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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00706771




Registration number
NCT00706771
Ethics application status
Date submitted
26/06/2008
Date registered
30/06/2008
Date last updated
30/06/2014

Titles & IDs
Public title
Bicarbonate and Lipocalin in Systemic Inflammatory Response Syndrome (SIRS) Study
Scientific title
A Randomized Double-blind Controlled Pilot Feasibility and Safety Trial of NGAL-directed Sodium Bicarbonate to Protect Renal Function in Patients With the Systemic Inflammatory Response Syndrome, Oliguria and Elevated Lipocalin Levels
Secondary ID [1] 0 0
TNH 18/08
Universal Trial Number (UTN)
Trial acronym
BLISS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Inflammatory Response Syndrome 0 0
Oliguria 0 0
Renal Impairment 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sodium bicarbonate
Treatment: Drugs - Sodium chloride

Active comparator: Sodium bicarbonate - sodium bicarbonate: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr

Active comparator: Sodium chloride - sodium chloride: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr


Treatment: Drugs: Sodium bicarbonate
Sodium bicarbonate: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr

Treatment: Drugs: Sodium chloride
0.9% sodium chloride: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The ability to deliver the study protocol safely and rapidly with a trend to improved renal outcomes
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
Attenuation in lipocalin levels
Timepoint [1] 0 0
28 days
Secondary outcome [2] 0 0
Decrease in the magnitude in serum creatinine rise
Timepoint [2] 0 0
28 days
Secondary outcome [3] 0 0
Ability to deliver the study protocol without significant biochemical side effects
Timepoint [3] 0 0
28 days

Eligibility
Key inclusion criteria
* Consent obtained
* Diagnosis of SIRS. Requires any TWO of:

temperature > 38°C or < 36°C OR heart rate > 90 beats/min OR respiratory rate > 20 breaths/min. PaCO2 < 32 mm Hg OR alteration of white blood cell count > 12,000 cells/mm3, < 4,000 cells/mm3, or the presence of > 10% immature neutrophils

* elevated lipocalin level
* Arterial line already in place
* Central venous catheter already in place
* Age = 18 years
* Within 24 hours of admission to the ICU
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unlikely to remain in ICU for >72 hours
* Moribund patient
* Pre-existing CKD, transplant or ESRD
* Receiving (or about to receive) continuous renal replacement therapy for acute renal failure at time of enrolment
* Diagnosis of acute GN, AIN, vasculitis or post-renal aetiology
* Known/suspected study allergy to sodium bicarbonate
* Enrolling physician concern about patient enrolment

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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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
1/09/2012
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Heidelberg, Melbourne
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg, Melbourne
Recruitment postcode(s) [2] 0 0
3154 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael C Reade, MBBS DPhil
Address 0 0
Austin & Northern Hospitals, University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00706771