A study to determine the feasibility of a trial investigating the effect of angiotensin II infusion on kidney damage in cardiac surgical patients

Phase 3

Completed

• Conditions: Acute kidney injury; Anaesthesiology - Other anaesthesiology; Surgery - Other surgery; Cardiovascular - Other cardiovascular diseases; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12621000195853
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-23
• Study Completion: 2021-11-29
• Last Update Posted: 28 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Adult > 18 years old; Cardiac surgery using cardiopulmonary bypass including coronary artery bypass grafting (CABG) surgery, valve surgery, combined CABG/valve surgery; Elevated risk of acute kidney injury (AKI) as predicted by a score >3 on the following scale (ie. 3.5 or greater):
- haemoglobin < 130g/l (2 points), creatinine >100umol/l (2 points), age > 70 (1.5 points), NYHA 4 (1.5 points), BMI > 30 (1.5points)

Exclusion Criteria

-Major aortic surgery, transplant surgery, pulmonary thrombendarterectomy, ventricular assist device placement
-Already receiving inotropic/vasopressor support
-Dialysis dependent
-Pre-existing uncontrolled hypertension
-Asthma with lung function tests demonstrating reversible airway obstruction or a history of admission to hospital with asthma exacerbations
-Severe LV systolic dysfunction (LVEF <30%)
-Significant pulmonary hypertension (ePSAP > 70mmHg, mPAP > 40mmHg)
-Pregnant or breastfeeding women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of study drug infusion as a percentage of total time. Assessed by patient record and infusion pump review.[Intraoperative and for up to 48 hours postoperative or discharge to ward];Percentage of patients approached who consent to the study. Assessed by screening log.[Prior to randomisation];Protocol compliance. Assessed by patient medical record.[At the conclusion of the study]