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

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).

Study Overview

• Status: Recruiting
• Conditions: Postoperative Morbidity; Goal Directed Therapy; Individualised Target; Postopera Mortality

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

• Study Contact: Name: Stéphane BAR, MD; Phone Number: 03 22 08 79 06; Email: bar.stephane@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens-Picardie
    • Contact: Stephane BAR; Phone Number: 03 22 08 79 06; Email: bar.stephane@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
patients with complications
patients without complication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
NUmber of risk factors associated with postoperative morbidity in major non-cardiac surgery	2 years
Number of risk factors associated with postoperative mortality in major non-cardiac surgery	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of risk factors associated with the occurrence of postoperative renal dysfunction.	2 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Actual): October 21, 2022
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Goal directed therapy; postoperative morbi-mortality; individualised target
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: PI2022_843_0099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No