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

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT05824260
Collaborator
(none)
350
Enrollment
1
Location
12.3
Anticipated Duration (Months)
28.6
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    350 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Risk Factors for Postoperative Complications in Major Non-cardiac Surgery: Post-hoc Analysis of the OPHIQUE Multicentre Study
    Actual Study Start Date :
    Jun 23, 2022
    Actual Primary Completion Date :
    Oct 21, 2022
    Anticipated Study Completion Date :
    Jul 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    patients with complications
    patients without complication

    Outcome Measures

    Primary Outcome Measures

    1. NUmber of risk factors associated with postoperative morbidity in major non-cardiac surgery [2 years]

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

    Secondary Outcome Measures

    1. Number of risk factors associated with the occurrence of postoperative renal dysfunction. [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Amiens-Picardie Amiens France 80054

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire, Amiens

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire, Amiens
    ClinicalTrials.gov Identifier:
    NCT05824260
    Other Study ID Numbers:
    • PI2022_843_0099
    First Posted:
    Apr 21, 2023
    Last Update Posted:
    Apr 27, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Centre Hospitalier Universitaire, Amiens
    Goal directed therapy
    postoperative morbi-mortality
    individualised target
    Additional relevant MeSH terms:
    Postoperative Complications

    Study Results

    No Results Posted as of Apr 27, 2023