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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Severe untreated or unbalanced hypertension

Preoperative renal failure on dialysis

Acute heart failure

Acute coronary insufficiency

Trial 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)

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

350 Participants
are grouped into 2 trial groups
Group A: patients with complications
Group B: patients without complication

Trial outcomes

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

Other outcomes

Sponsors and contacts

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