Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00878956




Registration number
NCT00878956
Ethics application status
Date submitted
8/04/2009
Date registered
9/04/2009
Date last updated
1/08/2012

Titles & IDs
Public title
Bicarbonate in Cardiac Surgery
Scientific title
A Phase IIb Multiple Blind Randomized Controlled Trial of Sodium Bicarbonate in Cardiac Surgery at High-risk of Acute Kidney Injury
Secondary ID [1] 0 0
H2007/02808
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Kidney Injury 0 0
Condition category
Condition code
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 - Sodium Bicarbonate
Treatment: Drugs - Sodium Chloride

Active comparator: 1 - In all patients body weight adjusted dose of study medication will be achieved by infusion of sodium bicarbonate at a dose of 0.5 mmol/kg body weight (=bolus) diluted in 250 mL over 1 hour immediately after the induction of anesthesia, prior to the first surgical incision followed by continuous intravenous infusion of 0.2 mmol/kg/hr (=maintenance) diluted in 1000 mL 23 hours (total dose of 5 mmol/kg over 24 hours).

Placebo comparator: 2 - In all patients body weight adjusted dose of study medication will be achieved by infusion of sodium chloride at a dose of 0.5 mmol/kg body weight (=bolus) diluted in 250 mL over 1 hour immediately after the induction of anesthesia, prior to the first surgical incision followed by continuous intravenous infusion of 0.2 mmol/kg/hr (=maintenance) diluted in 1000 mL 23 hours (total dose of 5 mmol/kg over 24 hours).


Treatment: Drugs: Sodium Bicarbonate
In all patients body weight adjusted dose of study medication will be achieved by infusion of sodium bicarbonate at a dose of 0.5 mmol/kg body weight (=bolus) diluted in 250 mL over 1 hour immediately after the induction of anesthesia, prior to the first surgical incision followed by continuous intravenous infusion of 0.2 mmol/kg/hr (=maintenance) diluted in 1000 mL 23 hours (total dose of 5 mmol/kg over 24 hours).

Treatment: Drugs: Sodium Chloride
In all patients body weight adjusted dose of study medication will be achieved by infusion of sodium chloride at a dose of 0.5 mmol/kg body weight (=bolus) diluted in 250 mL over 1 hour immediately after the induction of anesthesia, prior to the first surgical incision followed by continuous intravenous infusion of 0.2 mmol/kg/hr (=maintenance) diluted in 1000 mL 23 hours (total dose of 5 mmol/kg over 24 hours).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients developing an increase in serum creatinine greater than 25% or 44 mmol/L (0.5 mg/dL) postoperative increase in serum creatinine after adjustment for relevant baseline variables
Timepoint [1] 0 0
within first five postoperative days
Secondary outcome [1] 0 0
Mean changes in serum creatinine after adjustment for relevant baseline variables
Timepoint [1] 0 0
within first five postoperative days
Secondary outcome [2] 0 0
mean changes in serum cystatin C after adjustment for relevant baseline variables
Timepoint [2] 0 0
within first five postoperative days
Secondary outcome [3] 0 0
mean changes in urinary neutrophil gelatinase-associated lipocalin (NGAL)after adjustment for relevant baseline variables
Timepoint [3] 0 0
within first five postoperative days
Secondary outcome [4] 0 0
Duration of ventilation
Timepoint [4] 0 0
Until time of extubation from mechanical ventilation
Secondary outcome [5] 0 0
Proportion of patients developing any of the RIFLE criteria: R, I or F
Timepoint [5] 0 0
within first five postoperative days
Secondary outcome [6] 0 0
Incidence of post-operative atrial fibrillation
Timepoint [6] 0 0
within first five postoperative days
Secondary outcome [7] 0 0
Duration of stay in the intensive care unit (ICU)
Timepoint [7] 0 0
from admission to the ICU
Secondary outcome [8] 0 0
Duration of stay in hospital
Timepoint [8] 0 0
from admission to discharge from hospital
Secondary outcome [9] 0 0
90-day mortality
Timepoint [9] 0 0
during 90 days postoperatively
Secondary outcome [10] 0 0
Change in electrolyte status from baseline to peak
Timepoint [10] 0 0
within first 24-48hrs postoperatively

Eligibility
Key inclusion criteria
* Age above 70 years
* Pre-existing renal impairment (preoperative plasma creatinine concentration > 1.4 mg/dL
* New York Heart Association class III/IV or impaired left ventricular function (left ventricular ejection fraction < 50%)
* Valvular surgery or concomitant valvular and coronary artery bypass graft surgery
* Redo cardiac surgery
* Insulin-dependent diabetes mellitus
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* End stage renal disease (plasma creatinine concentration > 3.4 mg/dL)
* Emergency cardiac surgery
* Planned off-pump cardiac surgery
* Known blood-borne infectious disease
* Chronic inflammatory disease on immunosuppression
* Chronic moderate to high dose corticosteroid therapy (> 10 mg/d prednisone or equivalent)
* Enrolled in conflicting research study
* Age < 18 years

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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
427
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Melbourne
Recruitment hospital [2] 0 0
Warringal Private Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton

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
Rinaldo Bellomo, MD, FRACP
Address 0 0
Austin Hospital, Melbourne Australia
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/NCT00878956