Angiotensin in Septic Kidney Injury Trial

What Was Tested

The trial (phase 2) is built around Angiotensin II.

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.

It had two arms (groups): Angiotensin II (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Sepsis is the most common cause of ARF in the ICU.

It has been assumed that hypotension induced by severe sepsis results in organ hypoperfusion and subsequent kidney ischaemia.

This ischaemia has been believed to be one of the main factors, if not the principal factor, contributing to development of ARF in severe sepsis.

Surprisingly, there is little evidence to support this assumption.

Who Took Part

12 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: inability to provide or obtain consent;; 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;.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

Because people in this Angiotensin II study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between Angiotensin II and the comparison at some point, usually with a gap in between.

As a double-blind Angiotensin II study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2010-02 with completion listed for 2013-02.

It ran at 2 sites in Australia (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Urine output (time frame: During the 24 hours of infusion of study drug). Arterial blood pressure (time frame: During the 24 hour infusion of study drug).

It also tracked 9 secondary outcomes, for example Serum creatinine, Serum urea, Serum Cystatin C, Serum neutrophil gelatinase associated lipocalin (NGAL), Urinary cystatin C and Urinary NGAL.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Angiotensin II in 12 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Angiotensin II compound page, all human trials.