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Angiotensin in Septic Kidney Injury Trial

NCT00711789 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2011-06-23

No results posted yet for this study

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.

Conditions

  • Acute Renal Failure
  • Sepsis
  • Septic Shock

Interventions

DRUG

Angiotensin II

Angiotensin II will be given by continuous infusion for 24 hours starting at a dose of 5ng/kg/min and then titrated to a maximum dose of 15 ng/kg/min according to a blood pressure based protocol

DRUG

Saline placebo

Saline placebo will be given by continuous infusion according to a blood-pressure base protocol. This protocol will also incorporate noradrenaline for blood pressure control (as is true in the active drug arm), such that blood pressure targets will be rapidly achieved in both arms of the study; the only difference being that in the active drug arm, at least part of the pressor effect will be provided by angiotensin II.

Sponsors & Collaborators

  • Northern Health and Social Care Trust

    collaborator OTHER_GOV

  • Western Hospital, Australia

    collaborator OTHER_GOV

  • Austin Health

    lead OTHER_GOV

Principal Investigators

  • Michael C Reade, MBBS DPhil · Northern Hospital, Epping, Victoria, Australia

  • Forbes McGain, MBBS FJFICM · Western Hospital, Footscray, Victoria. Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2013-02-28

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00711789 on ClinicalTrials.gov