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Methods
PMC10512773
Study participants
AKI, sepsis
SEPSIS
This was a single-center double-blind randomized clinical trial that screened all consecutive patients admitted for AKI who met the diagnostic criteria for sepsis and had been evaluated by the Nephrology Department at the Hospital Civil de Guadalajara Fray Antonio Alcalde, a large referral center that cares for patient...
PMC10512773
Definitions
nausea, diarrhea, vomiting, rash, AKI
ADVERSE EVENT, KIDNEY DISEASE
AKI was defined as an increase in serum creatinine (sCr) levels according to Kidney Disease Improving Global Outcomes (KDIGO) [All comorbidities and clinical data were prospectively collected during the first evaluation.Adverse events were prespecified according to those most frequently reported with the use of probiot...
PMC10512773
Study outcomes
ADVERSE EVENTS
The primary outcome was KFR on day 7 (sCr return to <0.30 mg/dL from the baseline value). Secondary outcomes included variables related to KFR during the treatment and the follow-up period, namely, the change in urinary volume, percentage of decrease in sCr levels, in-hospital mortality, mortality during follow-up, KRT...
PMC10512773
Randomization and treatment assignments
AKI
Randomization was carried out by a computer-generated stratified sequence with a 1:1 allocation ratio in blocks of 5, with the groups stratified by sex. The researchers, who used a concealed opaque envelope system, performed group assignment after informed consent was obtained. A double-blind, double-dummy design was u...
PMC10512773
Interventions
Patients in the intervention group received 2 capsules of Simbin-RNL® or 2 capsules of placebo (maltodextrin) every 24 h for 7 consecutive days. The gastro-resistant Simbin-RNL® capsule contained 540 mg of a mixture of
PMC10512773
Statistical analysis
death, SD
REGRESSION
Categorical variables are presented as numbers and percentages, and comparisons between groups were performed with the chi-square or Fisher exact test as appropriate. The Shapiro–Wilk test was performed to assess data distribution; continuous variables are summarized as the means ± standard deviations (SD) if the data ...
PMC10512773
Results
AKI, sepsis
SEPSIS
From February 2019 to March 2022, 621 patients with AKI underwent nephrology consultation, and 123 did not have sepsis or they lacked variables of interest for the analysis; thus, 498 were assessed for eligibility, among whom 372 did not meet inclusion criteria, and 34 did not sign the consent form; therefore, 92 patie...
PMC10512773
Primary outcome
The KFR by day 7 is presented in Primary objective, kidney function recovery during the 7 days of the study trial.Primary and Secondary objectives.
PMC10512773
Secondary outcomes
uremia
REGRESSION, SECONDARY, VOLUME OVERLOAD, UREMIA
The results of the secondary outcomes are shown in Secondary outcomes, A) Survival, B) serum urea, and C) urinary output, during the 7 days of the study trial.A total of 17 (19%) patients required KRT during the study follow-up period, which was mostly due to uremia, volume overload, and electrolyte abnormalities; this...
PMC10512773
Additional outcomes of interest
Potassium levels decreased, and chloride levels increased during the study in both groups, but they did not differ significantly between intervention groups. Only sodium levels decreased in the probiotic group (134 ± 5.9), and they increased in the placebo group (137 ± 5.8) (
PMC10512773
Adverse events
ADVERSE EVENTS, ADVERSE EVENT
The prespecified adverse events during the study period are presented in Adverse events during the 7 days of study period.
PMC10512773
Discussion
CKD, fibrosis, intestinal dysbiosis, kidney dysfunction, sepsis-induced AKI, AKI, sepsis
ADVERSE EVENTS, FIBROSIS, KIDNEY DYSFUNCTION, SECONDARY, SEPSIS
In this double-blind randomized clinical trial carried out in patients with AKI secondary to sepsis, we found for the first time that the administration of probiotics for 7 days did not improve KFR compared with placebo treatment, but it had a trend to decrease the mortality rate, in addition to having an acceptable sa...
PMC10512773
Limitations and strengths
inflammation, AKI septic
INFLAMMATION
Our results must be interpreted with caution, as this was a single-center study without an The strengths of the study lie in its design and the adequate adherence of the patient groups to treatment; to our knowledge, this is the first randomized control trial of AKI septic patients treated with probiotics [In the next ...
PMC10512773
Conclusion
AKI, sepsis
SEPSIS
In AKI associated with sepsis, the administration of probiotics for 7 days was safe, and compared with placebo, it did not improve renal function, but there was a trend toward decreased mortality.
PMC10512773
Ethics approval and consent to participate
DEL
The study was approved by the Institutional Review Board HCG/CEI-1342/18, was registered with the Clinical Trials identifier NCT03877081, 03/15/2019 Informed consent was obtained from all subjects. All methods were carried out in accordance with relevant guidelines and regulations. All experimental protocols were appro...
PMC10512773
Authors’ contributions
RCD
CPH, MAY, GCA
JSCI, MIE, AMG-G, ACH, RCD, GCA, were responsible for the design, analysis and interpretation of the data. EMHB, ACRM, FRA, MLPM, MPC, JATG, CPH, GNB, RMG, LAV, KRL and GGG were responsible for data collection. All authors have read and approved the manuscript.The preprint version of the manuscript was posted in May 30...
PMC10512773
Disclosure statement
No potential conflict of interest was reported by the author(s).
PMC10512773
Availability of data and materials
Are available in the historical archive of the Hospital Civil Fray Antonio Alcalde. If any information is requested, please contact Principal Investigator Dr. Jonathan Chávez-Iñiguez (
PMC10512773
References
PMC10512773
Background
PONV, postoperative nausea and vomiting
The use of multimodal pharmacological prophylactic regimes has decreased postoperative nausea and vomiting (PONV) in general but it still occurs in over 60% of female patients after bariatric surgery. This study aimed to evaluate the efficacy of ST36 acupoint injection with anisodamine in prevention of PONV among femal...
PMC10338617
Methods
PONV, depression, anxiety
COMPLICATIONS
Ninety patients undergoing laparoscopic sleeve gastrectomy were randomly allocated to anisodamine or control group at the ratio of 2:1. Anisodamine or normal saline was injected into Zusanli (ST36) bilaterally after induction of general anesthesia. The incidence and severity of PONV were assessed during the first 3 pos...
PMC10338617
Results
vomiting
Baseline and perioperative characteristics were comparable between two groups. In the anisodamine group, 25 patients (42.4%) experienced vomiting within postoperative 24 h compared with 21 (72.4%) in the control group (relative risk 0.59; 95% confidence interval 0.40–0.85). Time to first rescue antiemetic was 6.5 h in ...
PMC10338617
Conclusions
obesity, nausea
OBESITY
The addition of ST36 acupoint injection with anisodamine significantly reduced postoperative vomiting without affecting nausea in female patients with obesity undergoing laparoscopic sleeve gastrectomy.
PMC10338617
Supplementary Information
The online version contains supplementary material available at 10.1007/s00464-023-10037-6.
PMC10338617
Keywords
PONV, postoperative nausea and vomiting, arthritis, shock
CARDIAC ARRHYTHMIAS, CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING, ARTHRITIS, SHOCK
More than 30% of postoperative patients in general still suffer from postoperative nausea and vomiting (PONV) within 24 h after surgery, and can be as high as 60–80% of high-risk patients based on Apfel score [Previous in vivo and in vitro studies have found that anisodamine can have therapeutic benefits in cardiac arr...
PMC10338617
Materials and methods
PMC10338617
Trial design and ethics
This single-center prospective, randomised, double-blinded study was approved by the Ethics Committee of the Second Affiliated Hospital of Anhui Medical University, Anhui province, China (Chairperson Prof. Yanghua Tian) on December 2, 2021 (Ref YX2021-114) in accordance to the principles of the Declaration of Helsinki....
PMC10338617
Participants
OSAHS, obesity, psychological disorder, endocrine disorder, obstructive sleep apnea hypopnea syndrome, rash, liver, coagulation derangements, allergic diathesis
OBESITY, OBSTRUCTIVE SLEEP APNEA HYPOPNEA SYNDROME, GASTROESOPHAGEAL REFLUX, ENDOCRINE DISORDER, DISEASES OF THE HEART, SYSTEMIC INFECTION
All adult female patients with an American Society of Anesthesia (ASA) physical status I–III, scheduled for elective LSG surgery were screened. The exclusion criteria: contraindications to acupoint injection, such as a local rash at the site of skin injection or systemic infection, any history of allergic diathesis for...
PMC10338617
Randomization and blinding
All participants were randomly assigned to anisodamine group (bilateral ST36 acupoint injection with anisodamine) or control group (bilateral ST36 injection with normal saline) in a 2:1 ratio. The randomization was computer-generated by using The allocation sequence was concealed until the end of data collection, and t...
PMC10338617
Standardized anesthesia management
Dexmedetomidine (0.5 μg kg
PMC10338617
ST36 acupoint injection and PONV management
PONV, Acupuncture
Acupuncture treatment was performed by a licensed acupuncturist who had at least 5 years of acupuncture experience. All participants received bilateral ST36 acupuncture injection with anisodamine (5 mg/1 ml per site) or normal saline (1 ml per site) [All patients received prophylaxis for PONV with dexamethasone (10 mg ...
PMC10338617
Outcomes
PONV, depression, vomiting, anxiety
SECONDARY, POSTOPERATIVE COMPLICATIONS
The primary outcome is the incidence of vomiting within the first 24 h postoperatively.The secondary outcomes include: the time to the first rescue antiemetic; the incidence of PONV assessed at 2, 6, 48, and 72 h after surgery; the severity of PONV measured by the Verbal Rating Scale (VRS) (none, mild, moderate, or sev...
PMC10338617
Statistical analysis
postoperative vomiting, vomiting
Based on the incidence of postoperative vomiting in our pilot study, the proportions of patients who experienced vomiting within 24 h after surgery in the control group and anisodamine group were 80% and 40% respectively (Table S1). The sample size was calculated to be 84 patients (28 in control and 56 in anisodamine),...
PMC10338617
Discussion
PONV, vomiting, patients-specific
In this trial, anisodamine was creatively used on ST36 acupoint injection in female patients during LSG. During the first postoperative 24 h, we successfully observed a significant reduction of the incidence of vomiting, an increase of the time to first rescue antiemetic, as well as less rescue antiemetic in patients w...
PMC10338617
Strengths and limitations
postoperative vomiting, postoperative nausea., PONV, Vomiting
This trial, based on previous studies, simplifies the procedure and duration of acupuncture and provides a comparable preventive effect on postoperative vomiting, which contributes to the popularization of acupuncture in preventing PONV. The results also provide strong evidence using anisodamine for PONV prevention.Thi...
PMC10338617
Conclusions
PONV
ST36 acupoint injection with anisodamine had incremental benefit when used as part of combination prophylaxis for reducing PONV. It could be a new option contained in multimodal prophylactic antiemetic regime in female patients undergoing laparoscopic sleeve gastrectomy.
PMC10338617
Funding
This study was supported by Basic and clinical cooperative research promotion plan of Anhui Medical University (Grant 2019xkjT026), the National Natural Science Foundation of China (Grant 81801050), Scientific Research Platform Base Construction and Promotion Project of Anhui Medical University (Grant 2020xkjT060), Key...
PMC10338617
Declarations
PMC10338617
Disclosures
Dr. Qi Xue, Qijing Xing, Ling Dong, Min Guo, Xiaoyan Zhang, Xinchun Wei, Dr. Benli Jia, Prof. Yong Wang, Hong Chen, Prof. Xianwen Hu, Prof. Hong Liu, Prof. Ye Zhang, Prof. Gordon Tin Chun Wong, Dr. Chunxia Huang have no conflicts of interest or financial ties to disclose.
PMC10338617
References
PMC10338617
Keywords
Open access funding provided by SCELC, Statewide California Electronic Library Consortium
PMC10412661
Introduction
TNBC, mTNBC, breast cancers, tumor
TRIPLE-NEGATIVE BREAST CANCER, TUMOR, BREAST CANCER, CHEMOTHERAPY EFFECTS, SOLID TUMORS
Triple-negative breast cancer (TNBC) accounts for 10–15% of all breast cancers and is characterized by lack of estrogen receptor (ER), progression receptor (PR), and human epidermal growth factor receptor 2 (HER2) overexpression. TNBC is molecularly heterogeneous, and metastatic TNBC (mTNBC) carries poor prognosis due ...
PMC10412661
Methods
PMC10412661
Study design and patient population
TNBC, mTNBC
ONCOLOGY, DISEASE, IMMUNODEFICIENCY
This open-label single institutional phase I trial for patients with metastatic TNBC was conducted between March 2016 and November 2019 with institutional review board (IRB) approval in accordance with the World Medical Association Declaration of Helsinki, International Conference on Harmonization Good Clinical Practic...
PMC10412661
Study procedure
Eligible patients received pembrolizumab 200 mg IV with doxorubicin 50–60 mg/m
PMC10412661
Clinical response statistics
toxicities
SECONDARY
The primary objective of the study was to evaluate ORR of pembrolizumab plus doxorubicin. The secondary objective was to assess clinical benefit rate (CBR) (no progression for > 24 weeks), progression-free survival (PFS), and overall survival (OS). Additional secondary endpoints were to assess the safety and tolerabili...
PMC10412661
Tumor immune biomarkers
tumor, Tumor, Breast Cancer
TUMOR, TUMOR, BREAST CANCER
Tumor biopsies were formalin-fixed paraffin-embedded (FFPE). Percentage of stromal TILs (sTILs) in tumor was evaluated using hematoxylin and eosin (H&E) diagnostic sections per International Immuno-Oncology Biomarker Working Group on Breast Cancer Guidelines [
PMC10412661
Peripheral blood immune correlatives
SEPARATION
Peripheral blood was collected at baseline (pre-treatment), C2D1, and post-cycle 3 (C4D1 or C6D1) for flow cytometry analysis. Peripheral blood was obtained using heparin collection tubes, and peripheral blood mononuclear cells (PBMCs) were isolated within 6 h using Ficoll-Paque Separation according to manufacturer’s i...
PMC10412661
Correlative studies statistics
Graphs and statistics were performed using GraphPad Prism 8.4.3. Statistics were generated using unpaired two-tailed Student T tests or multiple comparisons T tests with Dunnet’s or Holm-Sidak corrections as described. Calculated p values are displayed as *
PMC10412661
Results
PMC10412661
Patients
anthracycline-naive, death, respiratory failure, chronic respiratory disease
RESPIRATORY FAILURE, CHRONIC RESPIRATORY DISEASE
Between March 2016 and November 2019, a total of 10 patients were enrolled and treated with doxorubicin and pembrolizumab. The trial was stopped early due to poor accrual because of difficulty in identifying patients who were anthracycline-naive. All 10 patients were included in the safety evaluation. One patient with ...
PMC10412661
Treatment
The first 3 patients received doxorubicin at 50 mg/m
PMC10412661
Response and survival
sepsis, death, neutropenia, Tumor
SEPSIS, NEUTROPENIA, TUMOR
Of 10 patients treated, one patient (age 87) developed neutropenia, sepsis, and death after 1Relative Change in Tumor Size (
PMC10412661
Exceptional responder
ER/PR-positive, adenopathy, high-grade TNBC
DISEASE, MAY, ADENOPATHY, RESIDUAL DISEASE, PATHOLOGY, HER2-NEGATIVE BREAST CANCER
Patient was initially diagnosed with ER/PR-positive, HER2-negative breast cancer in 2002. She was treated with surgery, adjuvant cyclophosphamide methotrexate fluorouracil (CMF), and radiation therapy, followed by 5 years of adjuvant tamoxifen. In 2011, patient who recurred with high-grade TNBC received neoadjuvant doc...
PMC10412661
Treatment associated toxicities
neutropenia
ADVERSE EVENTS, ADVERSE EVENT, NEUTROPENIA
Grade 3–4 adverse events (AEs) per CTCAE 4.0 were neutropenia Grade 2–4 adverse event with attributions in “definite”, “possible”, “probable” per CTCAE 4.0
PMC10412661
Tumor immune biomarkers
PD, tumor
DISEASE, TUMOR
PD-L1 (22C3) testing showed 4 patients who were PD-L1 positive, 4 patients who were PD-L1 negative, and 2 patients who did not have PD-L1 results. Stromal TILs analysis of available tumor tissue was performed for 4 patients and showed 1 CR patient with 90% TILs (lymph node), 1 UPR patient with 5% TILs (axillary mass), ...
PMC10412661
PMBC immune cell composition
PD, CR/PR/SD
Baseline and on-treatment characteristics of peripheral blood immune cell composition were analyzed in response to therapy. Two high parameter (> 28) spectral cytometry panels were designed to identify both broad immune subsets and detailed T cell subsets. At baseline, we found no association of response and frequencie...
PMC10412661
T cell compositional changes over the course of treatment
heterogenous, PD, tumor, CM
TUMOR
Given the increased frequency of T cells from pre-treatment to C2D1, we next set to dissect features of T cell subsets in greater detail over the course of therapy and in context of tumor response. Within CD8 + and CD4 + T cell populations, we found no significant differences in frequencies of canonical naïve, central ...
PMC10412661
Expansion of a proliferative, exhausted CD8 + T cell population over the course of treatment
PD
Among all patients, the increase in CD8 + proliferating T cells was greatest in the patient with CR (1.7-fold change vs. mean 0.8 in PD/SD/PR), which led us to further investigate this T cell subset. From pre-treatment to C2D1, CD8 + proliferating T cells increased from 5.2 to 9.2% in the patient with CR but reduced fr...
PMC10412661
Discussion
PD, mTNBC, pembrolizumab-treated melanoma
PROLIFERATIVE, BREAST CANCER
Although limited by small sample size, the results of the current trial provide evidence that doxorubicin can be safely combined with pembrolizumab with Several studies have demonstrated utility of chemo-immunotherapy combination in treatment of mTNBC. FDA accelerated approval was granted to atezolizumab in March 2019 ...
PMC10412661
Supplementary Information
PD, SD, CM
DISEASE PROGRESSION, DISEASE
Below is the link to the electronic supplementary material.Supplemental Fig. 1. Broad immune characterization of peripheral blood of patients treated with doxorubicin and pembrolizumab at baseline. A) Pre-treatment peripheral blood samples were examined by flow cytometry for lymphocyte composition frequencies, includin...
PMC10412661
Acknowledgements
Cancer
CANCER
Merck provided research funding this study. The COH Biostatistics Core and Analytical Cytometry Core was supported by the National Cancer Institute of the National Institutes of Health (P30CA033572). This work was also supported by the National Institutes of Health (NIH)/National Cancer Institute (NCI) grant RO1CA20691...
PMC10412661
Author contributions
GS designed and supervised the study; JW and YY supervised data collection and analysis, manuscript preparation; XG, JL and SEY provided clinical data, study operations support, and manuscript preparation; PHF, CR, and YC provided statistical design and data analysis; CE, WG, and PPL performed and interpreted correlati...
PMC10412661
Funding
Cancer
CANCER
Open access funding provided by SCELC, Statewide California Electronic Library Consortium. This study was funded by Merck and supported by City of Hope Comprehensive Cancer Center.
PMC10412661
Data availability
All data and materials are presented in the article and additional files. Raw data are available upon request.
PMC10412661
Declarations
PMC10412661
Conflict of interest
Dr. Yuan has contracted research sponsored by Imugene, Minerva, Merck, Novartis, Genentech, and Pfizer, is a consultant for Pfizer, Immunomedics, and is on the Speakers Bureau for Genentech, AstraZeneca, Daiichi Sankyo, and Gilead. The other authors declare that they have no competing interests.
PMC10412661
Ethics approval and consent to participate
The study was approved by City of Hope IRB registered under NCT02648477. Procedures were performed in accordance with the ethical standards of the City of Hope, the national research committee, and the 1964 Declaration of Helsinki and International Conference on Harmonization Guidelines for Good Clinical Practice and l...
PMC10412661
Consent for publication
Not applicable.
PMC10412661
References
PMC10412661
Abstract
MPD, ESRD
END-STAGE RENAL DISEASE, ESRD, COMPLICATIONS
These authors contributed equally to this work.During urgent-start peritoneal dialysis (USPD) in end-stage renal disease (ESRD) patients, both adequate dialysis and skill training for fluid exchange are essential. However, automated peritoneal dialysis (APD) alone or manual fluid exchange peritoneal dialysis (MPD) alon...
PMC10269400
Keywords
PMC10269400
Introduction
bacteremia, PD, MPD, ESRD
END-STAGE RENAL DISEASE, ESRD
Peritoneal dialysis (PD) is an effective treatment for patients with end-stage renal disease (ESRD). PD initiation is usually recommended at least two weeks after peritoneal dialysis catheter (PDC) implantation [Urgent-start peritoneal dialysis (USPD) is defined as the initiation of PD within two weeks of PDC implantat...
PMC10269400
Materials and methods
PMC10269400
Design
WEST
This single-center, prospective, randomized, open-label, controlled study was approved by the Ethics Committee of West China Hospital of Sichuan University (approval number: 2020-891) and registered in the Chinese Clinical Trials Registry (
PMC10269400
Participants
ESRD, PD, electrolyte disorders, sepsis, acute heart failure
SEPSIS, RECRUITMENT, ELECTROLYTE DISORDER, COMPLICATIONS, UREMIC ENCEPHALOPATHY, WEST, SYSTEMIC INFECTION, HEART, ESRD, DISEASES, ACUTE HEART FAILURE
Nephrologists provided patients with ESRD requiring urgent dialysis with detailed information on possible treatment modalities. Individuals who preferred PD and were suitable for PD were eligible if they were aged 18–75 years. The study recruitment period was from March to December 2021 at the Department of Nephrology,...
PMC10269400
PDC implantation and PD schemes
PD
All patients received Tenckhoff catheters and prophylactic antibiotics were administered preoperatively. Two experienced nephrologists performed catheter implantations using open dissection, and those through laparoscopy were performed by a surgeon. All the PDC were implanted at the day surgery center. USPD was initiat...
PMC10269400
Termination of the study
PD, hernia, peritonitis
PERITONITIS, COMPLICATIONS, LEAKAGE
When patients experienced complications, such as leakage and mechanical complications of PDC, which disturbed normal PD therapy, medication and conservative treatment were administered, and PD was suspended for 3 days. In addition, the patients continued the study and completed the five-day USPD after such complication...
PMC10269400
Outcome measurements
catheter-related infection, exit-site infection, inguinal hernia, PD, tunnel infection, peritonitis, Catheter-related infections
PERITONITIS, COMPLICATIONS, LEAKAGE
The primary outcomes included clearance of small-molecule uremic toxins and PD technical survival rate. All patients underwent laboratory measurements before and after USPD, including serum levels of creatinine, blood urea nitrogen, albumin, sodium, potassium, magnesium, phosphorus, carbon dioxide combining power (COSe...
PMC10269400
Statistical analysis
All statistical analyses were performed using the Statistical Package for Social Sciences (SPSS) software (version 26.0). Continuous variables, which conformed to the normal distribution, were expressed as mean ± standard deviation, and comparisons between groups were performed using the Student’s
PMC10269400
Results
PMC10269400
Demographic and baseline characteristics
MPD
Overall, 74 patients were enrolled in this study. Among these, 60 completed the study, including 29 and 31 patients in the MPD and A-MPD groups, respectively (Flow diagram of enrollment, randomization, and follow-up of patients. MPD: manual fluid exchange peritoneal dialysis; A-MPD: combination of automated peritoneal ...
PMC10269400
Comparison of the laboratory parameters
After the five-day USPD treatment, the serum levels of creatinine, blood urea nitrogen, albumin, potassium, magnesium, and iPTH decreased dramatically (Self-comparison of laboratory parameters before and after USPD within groups.COComparison of the difference of laboratory parameters before and after USPD between the t...
PMC10269400
Short-term PD-related complications
COMPLICATIONS
In total, 21 patients experienced short-term complications during USPD treatment (PD-related complications during 5-day USPD treatment.PDC: peritoneal dialysis catheter.Reasons of quitting the study.PDC: peritoneal dialysis catheter.
PMC10269400
Time expenditure of nurses treating PD and patients’ test scores
PD
The mean time expenditure for dialysate exchange by nurses for the A-MPD group was 248.45 ± 6.20 min during the five days (including two manual fluid exchanges and connection and disconnection of cycler per day). The mean time expenditure in the MPD group was 256.86 ± 11.70 min/day (including four manual fluid exchange...
PMC10269400
PD technique survival and patient survival
PD, peritonitis
PERITONITIS
Here, 60 patients were followed up for 6 months. Two patients in the A-MPD group developed peritonitis during follow-up; one underwent removal of the PDC and was switched to hemodialysis, while the other resumed peritoneal dialysis after antibiotic treatment. In contrast, one patient in the MPD group received renal tra...
PMC10269400
Discussion
PD, ’ mistakes, MPD
COMPLICATION, COMPLICATIONS, LEAKAGE
This study is the first to combine APD with MPD in the treatment of USPD. Compared with MPD, the A-MPD mode had a better effect on removing small-molecule toxins. Simultaneously, the A-MPD mode could effectively save time for nurses treating PD and improve the skill training of patients. The incidence of short-term com...
PMC10269400
Conclusion
PD, acidosis, hyperkalemia
ACIDOSIS
The combination of APD with MPD during USPD treatment had more advantages in removing small-molecule toxins, correcting hyperkalemia and acidosis, reducing the burden of nurses by saving time and improving patients’ skills in fluid exchange. Therefore, this mode could be recommended as an adoptable and suitable PD moda...
PMC10269400
Acknowledgments
The authors express their sincere appreciation to all colleagues involved in the study for their participation in this trial. The authors would also like to acknowledge all the patients who participated in this trial.
PMC10269400
Authors’ contributions
XXX
XXX and HXQ enrolled patients in the study, evaluated the effect and safety, and collected the data. HXQ, PL, LX, and ZXL performed manual fluid exchange, APD, patient education, and training. XXX, WXF, and ZZY contributed to data analysis and manuscript preparation. LZ contributed to the concept, design, data analysis...
PMC10269400
Ethics approval and consent to participate
WEST
The study was approved by the Medical Ethics Committee of the West China Hospital of Sichuan University, Sichuan, China. This study followed the Declaration of Helsinki and written informed consent was obtained from the participants.
PMC10269400
Disclosure statement
No potential conflict of interest was reported by the author(s).
PMC10269400
Data availability statement
The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.
PMC10269400
References
PMC10269400
Evaluation and scale of operating procedures
The total score is 200 points. The patient is considered to be qualified if he or she got more than 120 points.
PMC10269400
Introduction
The COVID-19 pandemic exposed people to significant and prolonged stress. The psychosocial impacts of the pandemic have been well recognised and reported in high-income countries (HICs) but it is important to understand the unique challenges posed by COVID-19 in low- and middle-income countries (LMICs) where limited in...
PMC10105919
Methods and analysis
post-traumatic, post-traumatic stress
This cross-sectional study uses an online survey to administer a novel COVID Psychosocial Impacts Scale (CPIS) alongside established measures of psychological distress, post-traumatic stress, well-being and post-traumatic growth in the appropriate language. Participants will include adults aged 18 years and above, recr...
PMC10105919
Ethics and dissemination
Ethical approval was granted by the Human Ethics Committee, University of Otago, New Zealand (Ref. No. 21/102). In addition, international collaborators obtained local authorisation or ethical approval in their respective host universities before data collection commenced.Participants will give informed consent before ...
PMC10105919
Strengths and limitations of this study
post-traumatic
RECRUITMENT
This cross-sectional observational study will make a significant contribution to understanding the psychosocial impacts of the COVID-19 pandemic in seven low- and middle-income countries with different pandemic impacts.This study will quantify psychometric measures in countries where there is currently limited access t...
PMC10105919