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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05824260

Acronym

MULTIPAS

Enrollment

350

Registered

2023-04-21

Start date

2022-06-23

Completion date

2026-06-01

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Goal Directed Therapy, Individualised Target, Postopera Mortality, Postoperative Morbidity

Keywords

Goal directed therapy, postoperative morbi-mortality, individualised target

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

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

Countries

France

Contacts

CONTACTStéphane Bar, MD

bar.stephane@chu-amiens.fr03 22 08 79 06

Outcome results