Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The investigators will determine the feasibility, safety and efficacy of intravenous sodium
bicarbonate in reducing progression to overt acute renal failure in patients with the
systemic inflammatory response syndrome, and low urine output or early acute renal impairment
as defined by serum neutrophil gelatinase-associated lipocalin (NGAL).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00706771
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00706771