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NCT Number: NCT05824260

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

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).

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Key information

Conditions

Goal Directed Therapy Individualised Target Postopera Mortality Postoperative Morbidity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 2 years

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

    Time frame: 2 years

Secondary outcomes

  1. Number of risk factors associated with the occurrence of postoperative renal dysfunction.

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Stéphane Bar, MD

CONTACT

[email protected]

03 22 08 79 06

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: MULTIPAS

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2023
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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