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Clinical Trials/ISRCTN39653756
ISRCTN39653756
Completed
未知

Open, multi-centre, randomised controlled trial of cardiac output-guided fluid therapy with low dose inotrope infusion compared to usual care in patients undergoing major elective gastrointestinal surgery

Queen Mary University of London0 sites2,502 target enrollmentNovember 23, 2016

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Queen Mary University of London
Enrollment
2502
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30647034 protocol (added 12/02/2020)

Registry
who.int
Start Date
November 23, 2016
End Date
March 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Age 65 years and over
  • 2\. Patients undergoing major elective surgery involving the gastrointestinal tract that is expected to take longer than 90 minutes

Exclusion Criteria

  • 1\. Inability or refusal to provide patient consent
  • 2\. Clinician refusal (including intention to monitor cardiac output from the start of surgery regardless of study group allocation)
  • 3\. American Society of Anesthesiologists (ASA) score of I
  • 4\. Patients expected to die within 30 days
  • 5\. Acute myocardial ischaemia within 30 days prior to randomisation
  • 6\. Acute pulmonary oedema within 30 days prior to randomisation
  • 7\. Contra\-indication to low\-dose inotropic medication
  • 8\. Pregnancy at time of enrolment
  • 9\. Previous enrolment in the OPTIMISE II trial
  • 10\. Current participation in another clinical trial of a treatment with a similar biological mechanism or primary outcome measure

Outcomes

Primary Outcomes

Not specified

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