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

NCT05824260 | Unknown

• 1 other identifier: PI2022_843_0099
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Goal directed therapy; postoperative morbi-mortality; individualised target

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  2 years

Study Arms (2)

patients with complications

patients without complication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80054, France

RECRUITING

Central Study Contacts

Stéphane Bar, MD

CONTACT

03 22 08 79 06; bar.stephane@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 21, 2023
• Study Start: June 23, 2022
• Primary Completion: October 21, 2022
• Study Completion: July 1, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)