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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00711789




Registration number
NCT00711789
Ethics application status
Date submitted
7/07/2008
Date registered
9/07/2008
Date last updated
23/06/2011

Titles & IDs
Public title
Angiotensin in Septic Kidney Injury Trial
Scientific title
A Pilot Crossover Randomised Controlled Trial of Angiotensin II in Critically Ill Patients With Severe Sepsis and Acute Renal Failure
Secondary ID [1] 0 0
TNH 23/08
Universal Trial Number (UTN)
Trial acronym
ASK-IT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Renal Failure 0 0
Sepsis 0 0
Septic Shock 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Renal and Urogenital 0 0 0 0
Kidney disease
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Angiotensin II
Treatment: Drugs - Saline placebo

Active comparator: Angiotensin II -

Placebo comparator: Placebo -


Treatment: Drugs: 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

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Urine output
Timepoint [1] 0 0
During the 24 hours of infusion of study drug
Primary outcome [2] 0 0
Arterial blood pressure
Timepoint [2] 0 0
During the 24 hour infusion of study drug
Secondary outcome [1] 0 0
Serum creatinine
Timepoint [1] 0 0
At the end of the 24 hour infusion of study drug
Secondary outcome [2] 0 0
Serum urea
Timepoint [2] 0 0
At the end of the 24 hour infusion of study drug
Secondary outcome [3] 0 0
Serum Cystatin C
Timepoint [3] 0 0
At the end of the 24 hour infusion of study drug
Secondary outcome [4] 0 0
Serum neutrophil gelatinase associated lipocalin (NGAL)
Timepoint [4] 0 0
At the end of the 24 hour infusion of study drug
Secondary outcome [5] 0 0
Urinary cystatin C
Timepoint [5] 0 0
At the end of the 24 hour infusion of study drug
Secondary outcome [6] 0 0
Urinary NGAL
Timepoint [6] 0 0
At the end of the 24 hour infusion of study drug
Secondary outcome [7] 0 0
Urinary IL-18
Timepoint [7] 0 0
At the end of the 24 hour infusion of study drug
Secondary outcome [8] 0 0
Need for renal replacement therapy
Timepoint [8] 0 0
During ICU admisison
Secondary outcome [9] 0 0
Mortality
Timepoint [9] 0 0
ICU and 28 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Northern Hospital - Epping
Recruitment hospital [2] 0 0
The Western Hospital - Footscray
Recruitment postcode(s) [1] 0 0
3074 - Epping
Recruitment postcode(s) [2] 0 0
3011 - Footscray

Funding & Sponsors
Primary sponsor type
Government body
Name
Austin Health
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Northern Health and Social Care Trust
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Western Hospital, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00711789
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael C Reade, MBBS DPhil
Address 0 0
Northern Hospital, Epping, Victoria, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael C Reade, MBBS DPhil
Address 0 0
Country 0 0
Phone 0 0
+61394964838
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00711789