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

Postoperative Morbidity Clinical Trial

— MULTIPAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05824260
• Other study ID #: PI2022_843_0099
• Status: Recruiting
• Start date: June 23, 2022
• Est. completion date: July 2023

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Stéphane Bar, MD
• Phone: 03 22 08 79 06
• Email: bar.stephane[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: July 2023
• Est. primary completion date: October 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Goal Directed Therapy
• Postoperative Complications
• Postoperative Morbidity

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NUmber of risk factors associated with postoperative morbidity in major non-cardiac surgery		2 years
Primary	Number of risk factors associated with postoperative mortality in major non-cardiac surgery		2 years
Secondary	Number of risk factors associated with the occurrence of postoperative renal dysfunction.		2 years