Angiotensin in Septic Kidney Injury Trial

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of a systemic infusion of angiotensin II on haemodynamics and urine output in critically ill patients with severe sepsis/septic shock and acute renal failure.

It will also help determine the feasibility of conducting a definitive and adequately powered randomised controlled trial of angiotensin II in such patients that would assess mortality and need for renal replacement therapy as endpoints.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Austin Health
• Collaborators: Northern Health and Social Care Trust; Western Hospital, Australia
• Treatments: Angiotensin II; Angiotensinogen; Giapreza

Criteria

Inclusion Criteria:

• age ≥ 18 years

• within the first 24 hours of ICU admission

• an expected duration of ICU admission of at least 72 hours

• informed consent by patient or by proxy (i.e. next of kin)

• diagnosis of severe sepsis/septic shock

• diagnosis of kidney dysfunction (minimum RIFLE criteria - 'R'); and

• presence of a central venous catheter.

Exclusion Criteria:

• inability to provide or obtain consent;

• patient is moribund with expected death within 24 hours;

• known chronic kidney disease (CKD) or end-stage renal disease (ESRD) receiving chronic RRT;

• confirmed or suspected acute glomerulonephritis, acute interstitial nephritis, renal vasculitis or post-renal aetiology for kidney dysfunction;

• patient is already receiving (or is about to start) CRRT for acute renal failure at the time of enrolment;

• known or documented allergy to angiotensin II;

• MAP consistently > 100 mmHg with no pressor support and no easily treatable cause (eg. pain); and

• enrolling physician's belief that the study drug could not be administered for the expected study duration.