Angiotensin in Septic Kidney Injury Trial

NCT00711789 | Unknown Phase 2

• 1 other identifier: TNH 23/08
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Acute renal failure; Septic shock; angiotensin II; neutrophil gelatinase associated lipocalin (NGAL); cystatin C

Outcome Measures

Primary Outcomes (2)

• Urine output

  During the 24 hours of infusion of study drug

• Arterial blood pressure

  During the 24 hour infusion of study drug

Secondary Outcomes (9)

• Serum creatinine

  At the end of the 24 hour infusion of study drug

• Serum urea

  At the end of the 24 hour infusion of study drug

• Serum Cystatin C

  At the end of the 24 hour infusion of study drug

• Serum neutrophil gelatinase associated lipocalin (NGAL)

  At the end of the 24 hour infusion of study drug

• Urinary cystatin C

  At the end of the 24 hour infusion of study drug

Study Arms (2)

Angiotensin II

ACTIVE COMPARATOR

Drug: Angiotensin II

Placebo

PLACEBO COMPARATOR

Drug: Saline placebo

Interventions

Angiotensin II DRUG

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

Angiotensin II

Saline placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Austin Health: lead
• Northern Health and Social Care Trust: collaborator
• Western Hospital, Australia: collaborator

Study Sites (2)

Northern Hospital

Epping, Victoria, 3074, Australia

RECRUITING

The Western Hospital

Footscray, Victoria, 3011, Australia

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Sepsis; Shock, Septic

Interventions

Angiotensin II

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Angiotensins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Michael C Reade, MBBS DPhil

  Northern Hospital, Epping, Victoria, Australia

  PRINCIPAL INVESTIGATOR

• Forbes McGain, MBBS FJFICM

  Western Hospital, Footscray, Victoria. Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael C Reade, MBBS DPhil

CONTACT

+61394964838; michael.reade@austin.org.au

Forbes McGain, MBBS FJFICM

CONTACT

+613 8345 6639; forbes.mcgain@wh.org.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 9, 2008
• Study Start: February 1, 2010
• Primary Completion: February 1, 2013
• Last Updated: June 23, 2011

Record last verified: 2009-01

Locations

AU (2)