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
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)
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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