Determinants of postoperative complications after major non-cardiac surgery in a large patient group
Official title: Risk Factors for Postoperative Complications in Major Non-cardiac Surgery: Post-hoc Analysis of the OPHIQUE Multicentre Study
Run by Centre Hospitalier Universitaire, Amiens · NCT05824260 · Data updated 2026-11-12
This analysis tests which patient factors are linked to postoperative complications after major non-cardiac surgery using data from the OPHIQUE study.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | June 23, 2022 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT05824260 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) undergoing abdominal, orthopedic, or vascular major non-cardiac surgery under general anesthesia with expected duration >2 hours and at least moderate comorbidity (ASA II or higher).
✕Probably not a fit
Patients without the identified risk factors or those undergoing procedures outside the included surgical categories may not experience a benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This post-hoc analysis looks at how patient characteristics and intraoperative management relate to postoperative morbidity and mortality in adults undergoing major non-cardiac surgery lasting more than 2 hours. It uses data from a multicenter cohort focused on tissue perfusion during surgery, and aims to identify determinants of complications in a large real-world population. The study is observational and analyzes existing data rather than testing a single intervention. Results could help tailor perioperative care to reduce risks for high-risk patients.
Why it matters
Potential benefit: Finding actionable risk factors could help clinicians refine perioperative strategies to lower postoperative complications.
How similar studies have gone: Previous studies have explored single-parameter effects; this analysis extends understanding by examining determinants across a large, real-world population in an observational design.
Who can join: the full rules
Show full inclusion / exclusion 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 * Surgery under spinal anaesthesia and epidural only * Refusal to participate by the patient * Pregnant, parturient or breastfeeding women * Patients under guardianship or curators, under court protection or deprived of public rights * The patient already included in another therapeutic trial with an experimental molecule * Emergency surgery * Patients who do not want their personal data to be used in the framework of the research
Where it's running
-
CHU Amiens-Picardie
Amiens, France Recruiting
Study contacts
- Study coordinator: Stéphane Bar, MD
- Email: bar.stephane@chu-amiens.fr
- Phone: 03 22 08 79 06
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.