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Impact of Obesity on Postoperative Outcomes following cardiac Surgery (The OPOS study): rationale and design of an investigator-initiated prospective study.

ABSTRACT: INTRODUCTION:Increasing levels of obesity worldwide have led to a rise in the prevalence of obesity-related complications including cardiovascular risk factors such as diabetes, hypertension and dyslipidaemia. Healthcare providers believe that overweight and obese cardiac surgery patients are more likely to experience adverse postoperative outcomes. The body mass index (BMI) is the primary measure of obesity in clinical practice, without accounting for a patient's level of cardiopulmonary fitness or muscle mass. The objective of this study is to determine whether fitness capacity of obese cardiac surgical patients and biomarkers, alone or in combination, will help identify patients at risk for adverse outcomes when undergoing cardiac surgery. METHODS AND ANALYSIS:Patients between the ages of 18 and 75 years undergoing elective cardiac surgery are consented to participate in this prospective observational study. Patients will be invited to participate in measures of obesity, functional capacity and exercise capacity assessments, quality of life questionnaires, and blood and tissue sampling for biomarker analysis. The endpoints evaluated are measures other than BMI that could be predictive of short-term and long-term postoperative outcomes. Clinical outcomes of interest are prolonged ventilation, hospital length of stay, renal failure and all-cause mortality. Biomarkers of interest will largely focus on metabolism (lipids, amino acids) and inflammation (adipokines, cytokines and chemokines). ETHICS AND DISSEMINATION:This study has been approved by the institutional review board at the Horizon Health Network. On completion of the study, the results shall be disseminated through conference presentations and publications in peer-reviewed journals. Additionally, the report shall also be diffused more broadly to the general public and the cardiovascular community. TRIAL REGISTRATION NUMBER:NCT03248921.

SUBMITTER: Aguiar C

PROVIDER: S-EPMC6443054 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Impact of Obesity on Postoperative Outcomes following cardiac Surgery (The OPOS study): rationale and design of an investigator-initiated prospective study.

Aguiar Christie C MacLeod Jeffrey J Yip Alexandra A Melville Sarah S Légaré Jean-Francois JF Pulinilkunnil Thomas T Kienesberger Petra P Brunt Keith K Hassan Ansar A

BMJ open 20190303 3

<h4>Introduction</h4>Increasing levels of obesity worldwide have led to a rise in the prevalence of obesity-related complications including cardiovascular risk factors such as diabetes, hypertension and dyslipidaemia. Healthcare providers believe that overweight and obese cardiac surgery patients are more likely to experience adverse postoperative outcomes. The body mass index (BMI) is the primary measure of obesity in clinical practice, without accounting for a patient's level of cardiopulmonar ...[more]

PMID: 30833313

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Project description:BackgroundThe German Research Foundation (DFG) and the Federal Ministry of Education and Research (BMBF) initiated large research programs to foster high quality clinical research in the academic area. These investigator initiated trials (IITs) cover important areas of medical research and often go beyond the scope of industry sponsored trials (ISTs). The purpose of this project was to understand to what extent results of randomized controlled IITs and ISTs have an impact on medical practice, measured by their availability for decisions in healthcare and their implementation in clinical practice. We aimed to determine study characteristics influencing a trial's impact such as type of sponsor and place of conduct. In this article, we describe the rationale and design of this project and present the characteristics of the trials included in our study cohort.MethodsThe research impact of the following sub-cohorts was compared: German IITs (funded by DFG and BMBF or by other German non-commercial organizations), international IITs (without German contribution), German ISTs, and international ISTs. Trials included were drawn from the DFG-/BMBF-Websites, the German Clinical Trials Register, and from ClinicalTrials.gov . Research impact was measured as follows: 1) proportion of published trials, 2) time to publication, 3) proportion of publications appropriately indexed in biomedical databases, 4) proportion of openly accessible publications, 5) broadness of publication's target group, 6) citation of publications by systematic reviews or meta-analyses, and 7) appearance of publications or citing systematic reviews or meta-analyses in clinical practice guidelines. We also aimed to identify study characteristics associated with the impact of trials.ResultsWe included 691 trials: 120 German IITs, 200 International IITs, 171 German ISTs and 200 International ISTs. The median number of participants was 150, 30% were international trials and 70% national trials, 48% drug-trials and 52% non-drug trials. Overall, 72% of the trials had one pre-defined primary endpoint, 28% two or more (max. 36).ConclusionsThe results of this project deepen our understanding of the impact of biomedical research on clinical practice and healthcare policy, add important insights for the efficient allocation of scarce research resources and may facilitate providing accountability to the different stakeholders involved.

Project description:Background and objectivesHypothermia occurs commonly during surgery and can cause postoperative complications. We aimed to describe the characteristics and outcomes of hypothermia in patients undergoing major surgeries.MethodsThis prospective, observational, multicenter study of a nationally representative sample included all patients over 18 years of age admitted to an intensive care unit (ICU). Thirty ICUs were selected randomly at national level. The main outcome measure was the proportion of patients who developed postoperative hypothermia in the first 24 hours of ICU admission. Patients were divided into three groups based on temperature: <35°C, <36°C, and ≥36°C (no hypothermia). Patients' characteristics, postoperative complications, and risk factors were evaluated in all groups. To verify whether hypothermia was a strong risk factor for postoperative complications, a Kaplan-Meier curve was generated and adjusted using a Cox regression model.ResultsIn total, 738 patients had their temperatures measured. The percentage of patients with temperature <35°C (median [Q1-Q3], 34.7°C [34.3-34.9°C]) was 19.1% (95% confidence interval [CI] = 16.1-22.5) and that of patients with temperature <36°C (median [Q1-Q3], 35.4°C [35.0-35.8°C]) was 64% (95% CI = 58.3-70.0). The percentage of surgical complications was 38.9%. Patients with hypothermia were older, had undergone abdominal surgeries, had undergone procedures of longer duration, and had more comorbidities. A postoperative temperature ≤35°C was an independent risk for composite postoperative complications (hazard ratio = 1.523, 95% CI = 1.15-2.0), especially coagulation and infection.ConclusionsInadvertent hypothermia was frequent among patients admitted to the ICU and occurred more likely after abdominal surgery, after a long procedure, in elderly patients, and in patients with a higher number of comorbidities. Low postoperative temperature was associated with postoperative complications.

Project description:BackgroundInhibitor development is the most serious treatment-related complication of replacement coagulation factor VIII (FVIII) therapy for patients with haemophilia A. Immune tolerance induction (ITI), which involves intensive and prolonged treatment with plasma-derived or recombinant FVIII, is the only clinically proven strategy for eradication of inhibitors. The bispecific antibody emicizumab is approved for use in patients with and without inhibitors to prevent bleeding but does not eliminate inhibitors. MOTIVATE (www.motivate-study.com) aims to capture different approaches to the treatment and management of patients with haemophilia A and inhibitors, document current ITI approaches from real-world clinical experience, and evaluate the efficacy and safety of ITI, emicizumab prophylaxis and ITI with emicizumab prophylaxis.MethodsThe investigator-initiated MOTIVATE study [ClinicalTrials.gov identifier: NCT04023019; EudraCT 2019-003427-38] will investigate in real-life clinical practice the management of patients with haemophilia A of any severity who have developed inhibitors to FVIII. All treatment is at the investigator's discretion. The following treatment approaches will be evaluated: Group 1 - ITI with Nuwiq®, octanate® or wilate® and aPCC/rFVIIa if needed to treat bleeding episodes (BEs) or during surgery or for prophylaxis; Group 2 - ITI with Nuwiq®, octanate® or wilate® and emicizumab prophylaxis and aPCC/rFVIIa if needed to treat BEs or during surgery; Group 3 - routine prophylaxis with emicizumab, aPCC or rFVIIa without ITI and aPCC/rFVIIa if needed to treat BEs or during surgery. Patients will not be randomised to a treatment group and may change groups during the study.ConclusionsIt is planned to enrol 120 patients who will be followed for up to 5 years. Optional sub-studies will explore factors that may influence ITI results as well as the impact of different treatment approaches on important aspects of patient health, including joint and bone health and the risk of thrombotic events.

Dataset Information

Impact of Obesity on Postoperative Outcomes following cardiac Surgery (The OPOS study): rationale and design of an investigator-initiated prospective study.

Publications

Impact of Obesity on Postoperative Outcomes following cardiac Surgery (The OPOS study): rationale and design of an investigator-initiated prospective study.

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