Covid 19 Research using Clinical Trials (Home Page)
Report for D011183: Postoperative Complications NIH
(Synonyms: Postoperative Complicat, Postoperative Complicatio, Postoperative Complications)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
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There are 2 clinical trials
Clinical Trials
1 Outcomes of Vascular Surgery in COVID-19 Infection: National Cohort Study (Covid-VAS)
There is an urgent need to understand the outcomes of COVID-19 infected patients who undergo surgery, specially vascular surgery. Capturing real-world data and sharing Spanish national experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care. The global community has recognised that rapid dissemination and completion of studies in COVID-19 infected patients is a high priority, so we encourage all stakeholders (local investigators, ethics committees, IRBs) to work as quickly as possible to approve this project. This investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk. This study does not collect any patient identifiable information (including no dates) and data will not be analysed at hospital-level.
NCT04333693 Vascular Surgical Procedures COVID-19 Postoperative Complications Procedure: Vascular surgery MeSH:Postoperative Complications
Primary Outcomes
Description: 30-days mortality after vascular surgery in patients with COVID-19 infection
Measure: 30-days mortality Time: 30-daysSecondary Outcomes
Description: 7-days mortality after vascular surgery in patients with COVID-19 infection
Measure: 7-days mortality Time: 7-daysDescription: 30-days reoperation after vascular surgery in patients with COVID-19 infection
Measure: 30-days reoperation Time: 30-daysDescription: Postoperative ICU admission after vascular surgery in patients with COVID-19 infection
Measure: Postoperative ICU admission Time: 30-daysDescription: Postoperative respiratory failure after vascular surgery in patients with COVID-19 infection
Measure: Postoperative respiratory failure Time: 30-daysDescription: Postoperative acute respiratory distress syndrome (ARDS) after vascular surgery in patients with COVID-19 infection
Measure: Postoperative acute respiratory distress syndrome (ARDS) Time: 30-daysDescription: Postoperative sepsis after vascular surgery in patients with COVID-19 infection
Measure: Postoperative sepsis Time: 30-days2 SURgical Outcomes in COvid Patients - the SUROCO Multicenter Cohort Study
Overall mortality of COVID-19 is variable and has been reported to be between less than 1% and 7%. Many authors around the world also reported data on hospitalization rate, need for intensive care unit (ICU) care and need for mechanical ventilation in SARS-CoV-2 infected patients. To provide anesthetic and surgical care to SARS-CoV-2 infected patients, many health workers have to organize surgical platforms, personal protections and in-hospital trajectories to prevent dissemination and cross-contamination. However, no data has been published on the surgical need of these patients, their postoperative outcomes and the impact they may have on the operating room. Postoperative outcomes in SARS-CoV-2 infected patients are completely unknown. Expected benefits that justify a surgical procedure may be different in this population as well as the effects of preoperative characteristics on postoperative outcomes. The surgical needs of these patients, their postoperative outcomes as well as the associated workload imposed to operating rooms are unknown. There is a need to better quantify these and inform needed surgical resources in a pandemic. To address this knowledge gap, the investigators propose to conduct a multicenter observational cohort study in SARS-CoV-2 infected patients undergoing a surgical procedure.
NCT04458337 Covid-19 SARS-CoV2 Surgery Surgical Procedure; Complications, Late Effect of Complications Postoperative Complications MeSH:Postoperative Complications
Primary Outcomes
Description: Survival was calculated from the date of participant randomization to the date of participant death due to any cause, within 30 days after the surgery. If the participant was discharged from the hospital and not seen afterwards, the date of hospital discharge was entered as the last day seen alive.
Measure: Survival up to 30 days Time: 30 days post-operationSecondary Outcomes
Description: The respiratory complications were recorded as diagnosed by medical personnel and/or medical imaging. The complications included atelectasis, pneumonia, acute respiratory distress syndrome (ARDS) and pulmonary aspiration.
Measure: Occurrence of postoperative respiratory complications Time: 30 days post-operationDescription: The infection site complications were recorded as diagnosed by medical personnel and/or medical imaging. The infectious site included surgical incision or puncture site, surgical abscess, anastomotic leak, central nervous system, urinary tract infection, osteomyelitis, positive blood culture, etc. A postoperative infection had to be accompanied by an antimicrobial therapy lasting longer than 72 hours. In the event a patient suffered from two infections in the same site, both dates were recorded.
Measure: Occurrence of postoperative non-pulmonary infectious complications Time: 30 days post-operationDescription: The grade of AKI was classified according to the KDIGO-AKI criteria using the highest reported creatinine or the need for new renal replacement therapy after surgery, including any mode of renal replacement therapy.
Measure: Occurrence of acute kidney injury (AKI) Time: 30 days post-operationDescription: The thromboembolic complications were recorded as diagnosed by medical personnel and/or medical imaging. These included myocardial infarction, stroke, pulmonary embolism and cardiac arrest. Myocardial infarction was defined as a physician's diagnosis of a MI, which includes ST Elevation Myocardial Ischemia (STEMI) or Non-ST Elevation Myocardial Ischemia (NSTEMI).
Measure: Occurrence of postoperative thromboembolic complications Time: 30 days post-operationDescription: The dates for all ICU admissions and dates of ICU discharge were recorded. If the patient was readmitted to ICU following his initial admission to ICU, the dates for admissions and discharges were recorded.
Measure: The need for a new postoperative ICU admission Time: 30 days post-operationDescription: The number of days of hospital length of stay was calculated using the difference between the local date of discharge from the hospital and the date of hospital admission (day of surgery if ambulatory surgery). If the patient died during surgery or prior to hospital discharge, the patient's date of death was recorded as the date of discharge.
Measure: Hospital length of stay Time: An average of 7 daysDescription: The total number of days the patient was on invasive mechanical support was recorded. If mechanical ventilation was weaned and started again, the days when the patients were under mechanical ventilation were indicated. Non-invasive ventilation or high-flow nasal cannula (HFNC) were not included.
Measure: 30-day mechanical ventilation free-days Time: 30 days post-operationDescription: The total number of days the patient was: on invasive mechanical ventilator, under vasopressor therapy for more than 2 hours up to 30 days after surgery and spent under renal replacement therapy was recorded.
Measure: 30-day organ dysfunction free days Time: 30 days post-operationDescription: Any surgical reintervention in the operating room either related or unrelated to the initial intervention was recorded.
Measure: Surgical reinterventions Time: 30 days post-operationDescription: The dates for all ICU admissions and dates of ICU discharge were recorded. If the patient was admitted to ICU just after the index surgery, the date of ICU admission and time at which it occurred were recorded.
Measure: Any ICU admission during the index hospital stay Time: 30 days post-operationDescription: Time of room cleaning was defined from the time at which patient was transferred out of the operating room to the time at which the cleaning of the operating room ended.
Measure: Time of room cleaning Time: Number of minutes following patient transfer out of the operating room to end of cleaning, up to 60 minutes.Description: Survival was calculated from the date of participant randomization to the date of participant death due to any cause, within 6 months after the surgery.
Measure: 6-month survival Time: 6 months post-operation