A study of indicators of heart and circulation injury in adult patients undergoing major abdominal surgery.

Not Applicable

Completed

• Conditions: Postoperative infection; Gastrointestinal surgery; Postoperative complications; Anaesthesiology - Anaesthetics; Surgery - Other surgery; Cardiovascular - Other cardiovascular diseases; Infection - Other infectious diseases

• Registration Number: ACTRN12618001320246
• Lead Sponsor: St Vincent's Hospital Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-06
• Study Completion: 2022-10-12
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

Patients who have consented and recruited to the OptimiseII trial which includes
patients aged 65 years and over undergoing major elective surgery involving the gastrointestinal tract that is expected to take longer than 90 minutes.

Exclusion Criteria

•Inability or refusal to provide patient consent
•clinician refusal (including intention to monitor cardiac output from the start of surgery regardless of study group allocation)
•American Society of Anesthesiologists (ASA) score of I
•patients expected to die within 30 days
•acute myocardial ischaemia within 30 days prior to randomisation
•acute pulmonary oedema within 30 days prior to randomisation
•contra-indication to low-dose inotropic medication
•pregnancy at time of enrolment
•current participation in another clinical trial of a treatment with a similar biological mechanism or primary outcome measure

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Syndecan-1 levels between the two groups, usual care vs. GDT, will be compared and analyzed for a significant difference. Syndecan-1 levels will be assayed from serum blood samples.[ 0 hours (baseline before surgery) , 6 hours after surgery, 1 day after surgery (primary endpoint) and 2 days after surgery. ];Troponin levels between the two groups, usual care vs. GDT, will be measured by serum assay and analyzed for a significant difference.[ 0 hours (baseline before surgery) , 6 hours after surgery, 1 day after surgery (primary endpoint) and 2 days after surgery. ]

Secondary Outcome Measures

Name	Time	Method
Additional exploratory biomarkers of endothelial dysfunction may be explored. They will use the same serum sample collected at the same timepoints as the biomarkers specified in the primary outcome.[ 0 hours (baseline before surgery) , 6 hours after surgery, 1 day after surgery and 2 days after surgery. ]