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Sensitivity analyses | First, we performed a sensitivity analysis excluding patients from 2016, as only four patients received levosimendan this particular year (9% of total of patients eligible to our study in 2016), whereas the proportion of patients receiving levosimendan in 2017, 2018, and 2019 was quite stable (comprised between 26 and ... | PMC9906922 | ||
Subgroup analyses | ventricular heart failure | BIVENTRICULAR HEART FAILURE, ACUTE HEART FAILURE | Several subgroups were explored for the primary outcome, with tests for treatment-by-subgroup interaction. The interaction terms tested were: time to treatment assignment, or the effect of an early levosimendan administration versus a later one after beginning of VA-ECMO support (until day 2 or after day 2), time of EC... | PMC9906922 |
Missing data handling | Missing data for all covariates were handled with an approach that considers the time-dependence of the covariates in the imputation model [Robust variances were estimated by bootstrap (1000 iterations) to account for the fact that observations of patients have been duplicated in the analysis. Significance level was se... | PMC9906922 | ||
Results | PMC9906922 | |||
Population included at the beginning of ECMO support | transcatheter aortic valve, COPD | CHRONIC OBSTRUCTIVE PULMONARY DISEASE, COPD, VENTILATOR-ASSOCIATED PNEUMONIA | Between January 1, 2016, and December 31, 2019, 239 patients were included in the study, among whom 65 received levosimendan (flowchart, Fig. Flow diagram of the population included at the beginning of ECMO supportDescription of the population included at the beginning of ECMO supportBMI, body mass index; CABG, coronar... | PMC9906922 |
Outcomes of the population included at the beginning of ECMO support | Death | Levosimendan was administered after a median of 5 days after starting ECMO, Q1–Q3 [3–6]. The duration of ECMO was longer in the levosimendan group (median duration of 11 days, Q1–Q3 [7–16] versus 6 days, [3.25–9]), as well as the length of the ICU stay (median duration of 18 days, Q1–Q3 [14–33] versus 13 days, Q1–Q3 [6... | PMC9906922 | |
Target trial emulation | A total of 65 patients were included in the levosimendan group and 1369 copies of patients in the control group. The description of the target trial emulation population construction is shown in the flowchart in Fig. Flow diagram of the nested trials cohort. A nested trial was emulated each day (D) a patient received l... | PMC9906922 | ||
Outcomes | death, ECMO failure | SECONDARY, BIVENTRICULAR FAILURE | Regarding the time to successful ECMO weaning, no statistically significant association with levosimendan treatment was found in univariable analysis (cause-specific hazard ratio HR = 1.34, 95% confidence interval CI95 [0.92; 1.96], Cumulative incidences of ECMO weaning success in the presence of competing risks of dea... | PMC9906922 |
Discussion | primary graft dysfunction, postcardiotomy cardiogenic shock | PRIMARY GRAFT DYSFUNCTION | Our study did not find any association of levosimendan administration and ECMO weaning success or mortality in patients with refractory postcardiotomy cardiogenic shock. To our knowledge, this is the first emulated target trial evaluating the potential effect of levosimendan on ECMO weaning and mortality in this popula... | PMC9906922 |
Conclusion | postcardiotomy cardiogenic shock | Our study did not find an association of levosimendan administration and VA-ECMO-weaning or mortality in patients with refractory postcardiotomy cardiogenic shock. These results issued from one of the largest cohorts studied to date and the only one using the emulated target trial approach might cast some doubt on the ... | PMC9906922 | |
Author contributions | PD | JM performed the data collection and wrote the manuscript. NST and LB performed the statistical analysis and were major contributors in writing the manuscript. DH and YDR performed the statistical analysis. JT, GH, PD, BD, and ACh participated in medical care of the patients and performed the data collection. GL analyz... | PMC9906922 | |
Funding | No funding. | PMC9906922 | ||
Availability of data and materials | The datasets used and analyzed during the current study are available from the corresponding author on reasonable request. | PMC9906922 | ||
Declarations | PMC9906922 | |||
Ethics approval and consent to participate | CERAR | This is a single-center cohort study with retrospective data collection. Patients included in this study received standard of care without any change related to the research. Patient data were handled in accordance with the French regulations (MR004 reference methodology). The study protocol was approved by the Researc... | PMC9906922 | |
Competing interests | The authors declare no competing interests. | PMC9906922 | ||
References | PMC9906922 | |||
METHODS | PMC10189888 | |||
Statement of Ethics | The study protocol for ADMIRAL ( | PMC10189888 | ||
Patient Population and Study Design | REMISSION | Enrolled patients were age ≥18 years and in untreated first relapse after achieving complete remission (CR) with or without complete hematologic or platelet recovery with initial induction therapy or were refractory to initial induction therapy. All patients had a confirmed | PMC10189888 | |
Post-Transplantation Administration of Gilteritinib | For patients who proceeded to HSCT, gilteritinib therapy was stopped prior to beginning the conditioning regimen for HSCT. Patients could resume gilteritinib after HSCT if they achieved CRc and were between 30 and 90 days post-transplantation with successful engraftment (ie, absolute neutrophil count [ANC] ≥500/mm | PMC10189888 | ||
Data Analyses and Assessments | Response and survival outcomes were assessed in all patients who underwent HSCT. An analysis of a subset of gilteritinib arm patients who underwent HSCT and were without relapse for 60 days after HSCT was also performed. Response was assessed using modified International Working Group criteria ( | PMC10189888 | ||
Statistical Analyses | Descriptive statistics were used to assess continuous variables. Categorical data were reported as frequency and percentage. Hazard ratios (HRs) and supporting confidence intervals (CIs) were used to determine differences in OS between groups. Reported | PMC10189888 | ||
RESULTS | PMC10189888 | |||
Patient Disposition and Baseline Characteristics | As of the data cutoff date of September 20, 2020, 83 patients (gilteritinib arm, n = 64; SC arm, n = 19) in ADMIRAL had undergone HSCT (Demographic and baseline characteristics of the patients who underwent HSCT are shown in Detailed transplantation characteristics were available for 55 gilteritinib arm patients who un... | PMC10189888 | ||
OS by Transplantation and Remission Status | The median follow-up was similar in the HSCT and non-HSCT groups (35.9 months [95% CI, 34.0 to 39.9 months] versus 37.4 months [95% CI, 35.1 to 42.0 months]). The median OS was 20.2 months (95% CI, 14.1 to 36.2 months) in all patients who underwent HSCT (n = 83) and 6.8 months (95% CI, 6.1 to 7.9 months) in patients wh... | PMC10189888 | ||
Post-Transplantation Survival and Relapse | GVHD | DISEASE, GVHD | The median OS landmarked to the date of HSCT was 16.1 months in the gilteritinib arm and 15.3 months in the SC arm (HR, 1.076; 95% CI, .536 to 2.160) (Among gilteritinib arm patients who were alive and without relapse for 60 days after HSCT, the median OS land-marked from post-transplantation day 60 had not been reache... | PMC10189888 |
Pretransplantation Response | REMISSION | Although patients were not required to be in CRc to undergo HSCT, high pretransplantation remission rates were observed in both study arms ( | PMC10189888 | |
OS by Pretransplantation Treatment Response | Among the patients who underwent HSCT, no significant difference in OS (landmarked to the date of HSCT) was observed between the treatment arms among patients who achieved pretransplantation CRc and those who did not ( | PMC10189888 | ||
Post-Transplantation Relapse | death | Of the 64 gilteritinib arm patients who underwent HSCT, 52 (81%) achieved CRc either before or after transplantation; 36 of these 52 (69%) patients resumed gilteritinib after HSCT. Eight of these 36 patients relapsed; the median time to relapse was 6.6 months (range, 4.8 to 15.2 months) from the date of HSCT. The 17 pa... | PMC10189888 | |
Drug Exposure and Post-Transplantation Adverse Events after Restart of Gilteritinib Therapy | neutropenia, diarrhea, peripheral edema, thrombocytopenia, pyrexia, acute gastrointestinal GVHD, weight gain, hypokalemia | PLEURAL EFFUSION, DERMATOMYOSITIS, NEUTROPENIA, INCREASED BLOOD LACTATE, PERIPHERAL EDEMA, THROMBOCYTOPENIA, ACUTE GVHD, RESPIRATORY FAILURE, PLEURAL THICKENING, PANCYTOPENIA | In the patients who resumed gilteritinib after HSCT, the median dose of gilteritinib was 120 mg (range, 40 to 200), and the median duration of posttransplant gilteritinib maintenance therapy was 258.5 days (IQR, 51.5 to 823 days). The rate of grade ≥II acute GVHD after the restart of gilteritinib was 33% (n = 13 of 40)... | PMC10189888 |
DISCUSSION | transplantation-associated, AML, GVHD, Post-transplantation, transplantation-associated toxicities, hepatic dysfunction, myelosuppression | AML, SECONDARY, REMISSION, CARDIAC EVENTS, GVHD | The emergence of FLT3-targeted therapies administered in frontline or R/R settings enables patients with This post hoc analysis shows that bridging treatment with either gilteritinib or SC led to equivalent post-transplantation survival. Patients who resumed gilteritinib after HSCT had low relapse rates and longer OS c... | PMC10189888 |
Supplementary Material | PMC10189888 | |||
ACKNOWLEDGMENTS | PMC10189888 | |||
Financial disclosure: | This study was funded by Astellas Pharma, Inc. Medical writing/editorial support was provided by Kalpana Vijayan, PhD, and Cheryl Casterline, MA, from Peloton Advantage, LLC, an OPEN Health company and funded by the study sponsor. | PMC10189888 | ||
Conflict of interest statement: | N.H., Leukemia, R.T., AML, & Lymphoma, Celgene/Bristol, MaatPharma | ONCOLOGY, AML, LEUKEMIA | A.E.P. reports funding and other support from Astellas for this study; grants and contracts from AbbVie, Actinum Pharmaceuticals, Astellas, Daiichi Sankyo, Fujifilm, and Bayer; consulting fees from AbbVie, Astellas, Daiichi Sankyo, Forma Therapeutics, Sumitomo Dainippon Pharma, and Onconova; honoraria from Astellas and... | PMC10189888 |
Data sharing statement: | Researchers may request access to anonymized participant-level data, trial-level data, and protocols from Astellas-sponsored clinical trials at | PMC10189888 | ||
Subject terms | postoperative nausea and vomiting, hypotension | Serotonin 3 receptor antagonists, a commonly used drug for preventing postoperative nausea and vomiting, have recently been reported to decrease the incidence of hypotension and the need for vasoactive drugs after spinal anaesthesia in obstetric surgery. However, it remains unknown whether they could also prevent hypot... | PMC10354008 | |
Introduction | PONV, postoperative nausea and vomiting, Hypotension, hypotension | COMPLICATION | Hypotension is a common complication in patients under general anesthesiaEphedrine is an α- and β-adrenergic agonist that increases peripheral vascular resistance, cardiac output, and heart rate and thus maintains blood pressure. Prophylactic use of ephedrine at different doses (0.03–0.2 mg/kg) has been indicated to im... | PMC10354008 |
Materials and methods | PMC10354008 | |||
Study design and participants | ’ systolic blood pressure | RECRUITMENT | This study was approved by the Ethics Committee of Sir Run Shaw Hospital, School of Medicine, Zhejiang University (IRB No. 20200928-30) and all patients who participated in the study signed informed consent before recruitment. The trial was registered prior to patient enrollment at Chinese Clinical Trial Registry (regi... | PMC10354008 |
Statistical analysis | We decided to recruit 30 patients in each group because previous studies have suggested that data from 20 to 40 patients are sufficient to reliably estimate the ED50 for most scenarios in up-and-down method | PMC10354008 | ||
Discussion | postoperative pain, reduction in arterial blood pressure, hypotension, PONV, hypertension | BEZOLD, ADVERSE EVENTS, BLOOD, MOTION SICKNESS, HYPERTENSION | The current study is the first randomized placebo-controlled study that investigates the effect of intravenous granisetron on the ED50 of ephedrine for preventing hypotension after general anesthesia induction in elderly patients. We found that the ED50 of ephedrine for preventing hypotension after general anesthesia i... | PMC10354008 |
Acknowledgements | This work was supported by National Natural Science Foundation of China (No. 82171176 and No. 82001424), the Natural Science Foundation of Zhejiang Province (grant number: LZ19H090003, LQ23H090015) and the Health Commission of Zhejiang Province (grant number: 2021KY176). We would like to thank Fei Xiao, MD, the departm... | PMC10354008 | ||
Author contributions | Study design/planning: Y.Z., G.C., C.W. Study conduct: C.W., Y.Z., B.L., X.L., X.Y., Y.Z. Writing and revising of paper: all authors. | PMC10354008 | ||
Funding | This study was funded by by National Natural Science Foundation of China (No. 82171176 and No. 82001424), the Natural Science Foundation of Zhejiang Province (grant number: LZ19H090003, LQ23H090015), the Health Commission of Zhejiang Province (grant number:2021KY176) and registered at Chinese Clinical Trial Registry (C... | PMC10354008 | ||
Data availability | The de-identified data for individual participants underlying our results can be accessed with approval from the corresponding author 6 months after publication. The study protocol, statistical analyses, and clinical study report will also be available. | PMC10354008 | ||
Competing interests | The authors declare no competing interests. | PMC10354008 | ||
References | PMC10354008 | |||
PURPOSE | toxicity | ADVANCED CANCER, SECONDARY | Providing a geriatric assessment (GA) summary with management recommendations to oncologists reduces clinician-rated toxicity in older patients with advanced cancer receiving treatment. This secondary analysis of a national cluster randomized clinical trial (ClinicalTrials.gov identifier: | PMC9901996 |
METHODS | toxicity | LYMPHOMA, SOLID TUMORS | From 2014 to 2019, the study enrolled patients age ≥ 70 years, with advanced solid tumors or lymphoma and ≥ 1 GA domain impairment, who were initiating a regimen with high prevalence of toxicity. Patients completed PRO-CTCAEs, including the severity of 24 symptoms (11 classified as core symptoms) at enrollment, 4-6 wee... | PMC9901996 |
RESULTS | toxicity, GI or lung cancers | Mean age was 77 years (range, 70-96 years), 43% were female, and 88% were White, 59% had GI or lung cancers, and 27% received prior chemotherapy. In 706 patients who provided PRO-CTCAEs at baseline, 86.1% reported at least one moderate symptom and 49.7% reported severe/very severe symptoms at regimen initiation. In 623... | PMC9901996 | |
CONCLUSION | toxicity | ADVANCED CANCER | In the presence of a high baseline symptom burden, a GA intervention for older patients with advanced cancer reduces patient-reported symptomatic toxicity. | PMC9901996 |
INTRODUCTION | cancer | CANCER | More than 25% of all new cancer cases are diagnosed in patients age 75+ years. | PMC9901996 |
CONTEXT | toxicity, toxicities | ADVANCED CANCER |
Can geriatric assessment (GA)–based recommendations provided to oncologists improve patient-reported symptomatic toxicities in older adults initiating a new systemic treatment regimen?
In a clinical trial of older adults with advanced cancer initiating a new treatment regimen with a high prevalence of toxicity, 86% o... | PMC9901996 |
METHODS | PMC9901996 | |||
Study Design and Participants | toxicity | ONCOLOGY, LYMPHOMA, SECONDARY, SOLID TUMORS | This secondary analysis uses data from the GAP70+ trial, a nationwide study conducted in the University of Rochester NCI Community Oncology Research Program (UR NCORP). Community oncology practices were randomized to GA intervention or usual care. Eligible patients were age ≥ 70 years, had incurable solid tumors or lym... | PMC9901996 |
Measures | toxicity, toxicities, Cancer | DISEASES, CANCER | Demographics, including age, sex, ethnicity, and race, were collected as self-report measures. Cancer type and stage, history of prior chemotherapy, planned treatment, and physician-reported Karnofsky performance scoreSymptoms were evaluated with PRO-CTCAE to assess symptomatic toxicity and provide complementary data t... | PMC9901996 |
Statistical Analysis | toxicity, toxicities | ADVERSE EVENT | All patients who provided PRO-CTCAE data at baseline were included in the analysis of symptom burden at the initiation of the regimen, and those who also provided data for at least one postbaseline assessment were included in the analysis of symptomatic toxicity during treatment (Fig CONSORT flow diagram for symptomati... | PMC9901996 |
RESULTS | PMC9901996 | |||
Patient Characteristics | toxicity | Of 718 patients enrolled onto GAP70+, 706 (98.3%) provided PRO-CTCAEs at baseline. Of 706 patients, 83 (11.8%) patients provided PRO-CTCAE data only at baseline and could not be included in the analyses of symptomatic toxicity. Of these 83 patients, 39 (47.0%) died within 4-6 weeks, six (7.2%) withdrew from the study, ... | PMC9901996 | |
Baseline Symptom Burden as Measured by PRO-CTCAE | Figure Baseline symptom severity by arm. Patients reporting of symptom severity at baseline: (A) moderate or higher severity and (B) severe and very severe. * | PMC9901996 | ||
Symptomatic Toxicity | toxicity, toxicities, decreased appetite, Toxicity | After baseline, compared with usual care (n = 327), a lower proportion of patients who received the GA intervention (n = 296) reported grade ≥ 2 symptomatic toxicity (88.9% Effect of the GA intervention on patient-reported symptomatic toxicity reported over 6 months: (A) grade ≥ 2 and (B) grade ≥ 3. *When evaluating in... | PMC9901996 | |
DISCUSSION | tumor, dyspnea, fatigue, toxicities, pain, insomnia, small-cell lung cancer | ADVANCED CANCER, TUMOR | These analyses address important gaps in understanding the symptom experience of older adults with advanced cancer receiving systemic therapy. First, Gap70+ is the first nationwide cluster-randomized trial to demonstrate that a GA intervention can decrease patient-reported symptomatic toxicities. Second, the findings e... | PMC9901996 |
ACKNOWLEDGMENT | ONCOLOGY, ROSENTHAL | The authors would like to thank Susan Rosenthal, MD, for editing and Shuhan Yang, MS, for formatting of figures. The authors would like to thank the geriatric oncology research staff and University of Rochester NCI Community Oncology Research Base staff. The authors would also like to thank the patients, community onco... | PMC9901996 | |
PRIOR PRESENTATION | Presented in part at the 2020 ASCO Quality Care Symposium, virtual, October 9-10, 2020. | PMC9901996 | ||
SUPPORT | K24AG056589, Cancer | HAND PRESENTATION, CANCER | Supported by the National Cancer Institute (R01CA177592, U01CA233167, UG1CA189961, and R00CA237744) and the National Institute on Aging (K24AG056589 and P30-AG024832). The investigators were independent in the conduct of the analysis and presentation of the results. | PMC9901996 |
CLINICAL TRIAL INFORMATION |
E.C. and S.G.M. contributed equally to this work as co‐first authors. | PMC9901996 | ||
DATA SHARING STATEMENT | Cancer | CANCER | The study protocol, statistical analysis plan, informed consent form, and clinical study reports are available on the Cancer and Aging Research Group website ( | PMC9901996 |
AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST | PMC9901996 | |||
APPENDIX | toxicity, cancer type, Toxicity | Baseline symptom severity by study arm in patients analyzed for symptomatic toxicity. Patient-reported symptomatic toxicity over 6 months stratified by cancer type and prior treatment history: (A) grade ≥ 2 (all symptoms), (B) grade ≥ 2 (core symptoms), (C) grade ≥ 3 (all symptoms), and (D) grade ≥ 3 (core symptoms). G... | PMC9901996 | |
REFERENCES | PMC9901996 | |||
Purpose | Stage III gastric cancer | STAGE III GASTRIC CANCER | A phase III trial comparing S-1 and docetaxel with S-1 alone as postoperative chemotherapy for pathologically Stage III gastric cancer was conducted and clarified the superiority of the doublet in terms of 3-year relapse-free survival as the primary endpoint (67.7% versus 57.4%, hazard ratio [HR] 0.715, 95% confidence ... | PMC10640480 |
Patients and methods | STAGE III GASTRIC CANCER | Patients with histologically confirmed Stage III gastric cancer who underwent gastrectomy with D2 lymphadenectomy were randomly assigned to receive adjuvant chemotherapy with either S-1 plus docetaxel or S-1 alone. The same 912 patients who were evaluated for 3-year survival outcomes in the previous report were analyze... | PMC10640480 | |
Results | Five-year overall survival rate of the S-1 plus docetaxel group (67.91%) was significantly superior to that in the S-1 group (60.27%; HR 0.752, 95% CI 0.613–0.922; | PMC10640480 | ||
Conclusion | RECURRENCES, STAGE III GASTRIC CANCER | The survival benefit of postoperative chemotherapy with S-1 and docetaxel in terms of 5-year overall survival rate was confirmed for patients with pathologically Stage III gastric cancer, although late recurrences were not prevented. | PMC10640480 | |
Keywords | PMC10640480 | |||
Introduction | gastric cancer | RECURRENCES, RECURRENCE, WEST, SECONDARY, STAGE III GASTRIC CANCER, GASTRIC CANCER | The prognosis of patients with gastric cancer is dismal once recurrence occurs after curative surgery. Optimal adjuvant treatments to avoid recurrence have been explored extensively, resulting in some differences in current standards of care between the West and Far East [JACCRO GC-07 is a randomized phase III study ex... | PMC10640480 |
Patients and methods | PMC10640480 | |||
Patients and interventions | Details of this randomized phase III trial have already been published [Patients were to be followed-up for 5 years. The method of follow-up has been described previously [ | PMC10640480 | ||
Outcomes | death | ADVERSE EVENTS, DISEASE, RECURRENCE, RECURRENCE | The primary endpoint was 3-year RFS. Secondary endpoints were 3-year OS rate, 5-year OS rate, 5-year RFS rate, and incidence of adverse events. OS is defined as the time from randomization to death from all causes. RFS is defined as the time from randomization to either disease recurrence or death from all causes. Recu... | PMC10640480 |
Study design and statistical analysis | REGRESSION | Sample size calculations were based on data from the previous phase III studyCumulative survival curves and annual survival rates were estimated using Kaplan–Meier curves. Between-group analyses were conducted using stratified log-rank tests. Hazard ratios (HRs) and two-sided 95% confidence intervals (CIs) were estimat... | PMC10640480 | |
Results | death, armIncidence | ADVERSE EVENTS, RECURRENCES, RECURRENCE, METASTASIS | Final survival analyses were conducted at a median follow-up of 63.7 months (range: 3.5–111.9 months). Time from the date of randomization of the last enrolled case to the data cutoff date was 66.8 months. Data from the 55 patients lost to follow-up within 5 years from the date of random assignment were censored as of ... | PMC10640480 |
Acknowledgements | Cancer | CANCER | The authors wish to thank Dr. Toshifusa Nakajima, the former Vice President of the Japan Clinical Cancer Research Organization (JACCRO), for his advisory role, Drs. Yasuhiro Shimada, Kenji Omura, and Toru Takebayashi for their roles on the independent data and safety monitoring committee, and Ms. Sachika Koyama for dat... | PMC10640480 |
Data availability | Cancer | CANCER | The data that support the findings of this study are not openly available due to reasons of sensitivity and are available from Japan Clinical Cancer Research Organization (jaccro@jaccro.or.jp) upon reasonable request. Data are located in controlled access data storage at Japan Clinical Cancer Research Organization. | PMC10640480 |
Declarations | PMC10640480 | |||
Conflict of interest | Johnson & Johnson, Kaken Pharma, and Kyowa Kirin, Gastric Cancer | GASTRIC CANCER | Yasuhiro Kodera reports grants from Kaken Pharma, Otsuka, Shionogi, Nihon Kayaku, Daiichi Sankyo, Taiho Pharma, Abbot, Pfizer, and Bayer, and grants and personal fees from Chugai Pharma, Daiichi Sankyo, Taiho Pharma, Abbvie, Lilly Japan, Yakult, Ono Pharmaceutical, Bristol-Myers Squibb, Amgen, and MSD, and takes a role... | PMC10640480 |
Ethical approval | The study was conducted in accordance with the principles of the Declaration of Helsinki 2013 and the Japanese Ethical Guidelines for Medical and Health Research Involving Human Subjects. The study protocol was approved by the institutional review board of each participating hospital. Written informed consent was obtai... | PMC10640480 | ||
References | PMC10640480 | |||
1. Introduction | Endothelial dysfunction, inflammation, ischaemia | ACUTE CHOLECYSTITIS, VASODILATION, DISEASE PROGRESSION, HYPERAEMIA, ENDOTHELIAL DYSFUNCTION, INFLAMMATION, CARDIOVASCULAR MORBIDITY, EVENTS, ISCHAEMIA, ENDOTHELIAL DYSFUNCTION | Endothelial dysfunction result from inflammation and excessive production of reactive oxygen species as part of the surgical stress response. Remote ischemic preconditioning (RIPC) potentially exerts anti-oxidative and anti-inflammatory properties, which might stabilise the endothelial function after non-cardiac surger... | PMC10047371 |
2. Materials and Methods | PMC10047371 | |||
2.1. Trial Design and Setting | acute cholecystitis | ACUTE CHOLECYSTITIS | The trial was a single centre, randomised clinical trial including patients from the Department of Surgery, Zealand University Hospital in Denmark. It was designed to test the effect of RIPC on postoperative endothelial function in patients diagnosed with acute cholecystitis undergoing subacute laparoscopic cholecystec... | PMC10047371 |
2.2. Participants | acute cholecystitis, fractures, cholangitis | ACUTE CHOLECYSTITIS, PANCREATITIS, CHOLANGITIS | Inclusion criteria were adults (≥18 years) diagnosed with acute cholecystitis and scheduled for subacute laparoscopic cholecystectomy. Patients with symptoms for a maximum of seven days prior to surgery were eligible for inclusion if informed consent could be obtained. Surgeries were performed between 8 A.M. and 8 P.M.... | PMC10047371 |
2.3. Randomisation and Blinding | Patients were randomised into an intervention group or control group. A third party generated the allocation sequence at | PMC10047371 | ||
2.4. Intervention | ischaemia, diabetes | ISCHAEMIA, DIABETES | All patients received standard care according to local guidelines during their hospital stay, regardless of study allocation (standard regimen of (1) antibiotics: intra venous infusion with metronidazole 500 mg every eight hours and piperacillin/tazobactam 4 g every six hours; (2) analgetic: acetaminophen 1 g every six... | PMC10047371 |
2.5. Outcomes | SECONDARY, HYPERAEMIA | Our primary outcome was group-differences in perioperative changes in endothelial function, assessed as the reactive hyperaemia index (RHI), from baseline (preoperative assessment) to 2–4 h and 24 h (postoperative day 1, POD1) after surgery. Our secondary outcomes were group differences in perioperative changes in biom... | PMC10047371 | |
2.6. Data Sources | BLOOD | Non-invasive digital pulse amplitude tonometry (Endopat2000; Itamar Medical Ltd., Caesarea, Israel, Software Version 3.7.x) was used to assess endothelial function at patient inclusion (preoperative), 2–4 h after surgery and 24 h after surgery [Whole blood was withdrawn into ethylenediamine tetra-acetic acid (EDTA) tub... | PMC10047371 | |
2.7. Statistical Analyses | This was an explorative study and as such, no sample size calculation was performed. Patients undergoing RIPC, as described in the protocol, and having one preoperative blood sample and at least one postoperative blood sample withdrawn were included for analyses in this study. Categorical data are expressed as units (n... | PMC10047371 | ||
3. Results | PMC10047371 | |||
3.1. Patients | acute cholecystitis | ACUTE CHOLECYSTITIS | Sixty patients undergoing surgery due to acute cholecystitis were included in this study during a 24-month period. The details on the patient flow are illustrated in The demographics of the study population, including distribution of comorbidities, daily medication, and ASA group, were comparable between the control gr... | PMC10047371 |
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