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Clinical Trials/NCT05824260
NCT05824260
Recruiting
Not Applicable

Risk Factors for Postoperative Complications in Major Non-cardiac Surgery: Post-hoc Analysis of the OPHIQUE Multicentre Study

Centre Hospitalier Universitaire, Amiens1 site in 1 country350 target enrollmentJune 23, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Goal Directed Therapy
Sponsor
Centre Hospitalier Universitaire, Amiens
Enrollment
350
Locations
1
Primary Endpoint
NUmber of risk factors associated with postoperative morbidity in major non-cardiac surgery
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Post-operative morbidity and mortality is related to many factors related to the patient's condition, the intra-operative period and the optimisation of intra-operative haemodynamic and respiratory parameters. Many studies have looked at the determinants and factors that increase postoperative complications. However, these have been randomised studies looking at one parameter in particular.

This analysis would be the first to investigate the determinants of postoperative complications in a large population of patients undergoing major non-cardiac surgery. This is a post-hoc analysis of patients included in the OPHIQUE study, whose main objective was to evaluate intraoperative haemodynamic management guided by a marker of tissue hypoperfusion (the respiratory quotient).

Registry
clinicaltrials.gov
Start Date
June 23, 2022
End Date
July 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Abdominal, orthopaedic or vascular surgery under general anaesthesia and with an estimated duration of surgery \> 2 hours
  • Adult patients (age ≥ 18 years)
  • ASA score ≥ II
  • Patient with at least two of the following comorbidities: age \> 50 years, high blood pressure (HTA), heart failure, ECG abnormality, smoking, stroke, transient ischemic attack (TIA), peripheral arterial disease (PAD), insulin-dependent or non-insulin-dependent diabetes mellitus (NIDDM), ascites, chronic renal failure (CRF)
  • Signature of the consent form
  • Affiliation to a social security scheme

Exclusion Criteria

  • Severe untreated or unbalanced hypertension
  • Preoperative renal failure on dialysis
  • Acute heart failure
  • Acute coronary insufficiency
  • Vascular surgery with renal plasty
  • Cardiac surgery
  • Permanent laparoscopy
  • Chronic respiratory failure with home oxygen therapy
  • Acute respiratory distress syndrome with FiO2\>60%.
  • Preoperative shock

Outcomes

Primary Outcomes

NUmber of risk factors associated with postoperative morbidity in major non-cardiac surgery

Time Frame: 2 years

Number of risk factors associated with postoperative mortality in major non-cardiac surgery

Time Frame: 2 years

Secondary Outcomes

  • Number of risk factors associated with the occurrence of postoperative renal dysfunction.(2 years)

Study Sites (1)

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