Perioperative medicine & outcomes

Cardiac output-guided haemodynamic therapy for patients undergoing major gastrointestinal surgery: OPTIMISE II randomised clinical trial

BMJPublished Randomised controlled trial

Primary resultResult — go to the resultAdjusted odds ratio 1.03 95% CI 0.84–1.25

Authors' conclusion

This clinical effectiveness trial in patients undergoing major elective gastrointestinal surgery did not provide evidence that cardiac output-guided intravenous fluid therapy with low dose inotrope infusion could reduce the incidence of postoperative infections. The intervention was associated with an increased incidence of acute cardiac events within 24 hours, in particular tachyarrhythmias.

Study context

Population
Adults aged ≥65 years, ASA physical status II or greater, undergoing major elective gastrointestinal surgery; 55 hospitals worldwide, January 2017–September 2022
Participants
2,498 adults
Comparison
Intervention vs Usual care
Primary endpoint
Postoperative infection
Follow-up
Within 30 days of randomisation
Methodological detailsmulticentre
  • Multicentre

Primary result

As reported in the abstract

Adjusted odds ratio

1.03

95% CI 0.84–1.25

P = 0.81

Events by treatment group

Intervention vs Usual care
aOR 1.03 (95% CI 0.84–1.25); P = 0.81

Secondary outcomes

Other secondary outcomes (AKI within 30 days, mortality within 180 days)

Other secondary outcomes did not differ

Safety

OutcomeInterventionUsual careaOR (CI)P value
Acute cardiac events · within 24 hours3.0%1.7%1.82 (1.06–3.13)P = 0.03
Acute cardiac events · within 30 days6.8%6.3%1.06 (0.77–1.47)P = 0.71
  • Acute cardiac events: difference primarily due to increased incidence of arrhythmias in intervention patients

Original publication

Cardiac output-guided haemodynamic therapy for patients undergoing major gastrointestinal surgery: OPTIMISE II randomised clinical trial. BMJ. Published 3 December 2024. doi:10.1136/bmj-2024-080439

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