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/NCT00672334




Registration number
NCT00672334
Ethics application status
Date submitted
1/05/2008
Date registered
6/05/2008
Date last updated
1/08/2012

Titles & IDs
Public title
Sodium Bicarbonate in Cardiac Surgery Study
Scientific title
A Multicenter, Randomized, Double Blind, Placebo Controlled Study of the Effect of Sodium Bicarbonate on Postoperative Renal Function in Patients Undergoing Elective Cardiopulmonary Bypass
Secondary ID [1] 0 0
EudraCT 2007-002223-32
Universal Trial Number (UTN)
Trial acronym
Bic-MC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Surgery 0 0
Cardiopulmonary Bypass 0 0
Condition category
Condition code

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

Placebo comparator: 2 - sodium chloride at 0.5 mmol/kg loading pre-induction and then at 0.2 mmol/kg/hr over 24 hours after induction until the next day

Experimental: 1 - The active intervention is loading (05. mmol/kg) pre-surgery and continuous infusion of bicarbonate at 0.2 mmol/kg/hr for 24 hours after induction


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 > 25% or >44µmicromol/L from baseline to peak level after adjustment for relevant baseline characteristics
Timepoint [1] 0 0
within first two-five postoperative days.
Secondary outcome [1] 0 0
Proportion of patients developing an increase in serum creatinine greater than 50% from baseline to peak level after adjustment for relevant baseline characteristics
Timepoint [1] 0 0
within first two-five postoperative days
Secondary outcome [2] 0 0
Proportion of patients developing an increase in serum creatinine greater than 100% from baseline to peak level after adjustment for relevant baseline characteristics
Timepoint [2] 0 0
within first two-five postoperative days
Secondary outcome [3] 0 0
Change in serum creatinine from baseline to peak level after adjustment for relevant baseline characteristics
Timepoint [3] 0 0
within first two-five postoperative days
Secondary outcome [4] 0 0
Proportion of patients developing any of the RIFLE criteria: R, I or F after adjustment for relevant baseline characteristics
Timepoint [4] 0 0
within first five postoperative days
Secondary outcome [5] 0 0
Proportion of patients developing any of the AKI stages: 1, 2 or 3 (using network definition)after adjustment for relevant baseline characteristics
Timepoint [5] 0 0
within 48 hours postoperatively
Secondary outcome [6] 0 0
Change in serum urea from baseline to peak
Timepoint [6] 0 0
within first two-five postoperative days
Secondary outcome [7] 0 0
Change in NGAL from baseline to peak
Timepoint [7] 0 0
within first 24 postoperatively
Secondary outcome [8] 0 0
Change in electrolyte status from baseline to peak
Timepoint [8] 0 0
within first 24-48hrs postoperatively
Secondary outcome [9] 0 0
Requirement of renal replacement therapy
Timepoint [9] 0 0
within first postoperative days
Secondary outcome [10] 0 0
Length of ventilation
Timepoint [10] 0 0
from commencement to end of intubation
Secondary outcome [11] 0 0
Length of stay in Intensive care
Timepoint [11] 0 0
from admission to discharge from Intensive care
Secondary outcome [12] 0 0
Length of stay in hospital
Timepoint [12] 0 0
from admission to discharge from hospital
Secondary outcome [13] 0 0
Hospital-Mortality
Timepoint [13] 0 0
during hospital stay
Secondary outcome [14] 0 0
90-day mortality
Timepoint [14] 0 0
during 90 days postoperatively
Secondary outcome [15] 0 0
COMT polymorphism
Timepoint [15] 0 0
sampling at induction of anesthesia

Eligibility
Key inclusion criteria
* Cardiac surgical patients in whom the use of cardiopulmonary bypass was planned and:
* Written informed consent of patient
* Age >18 years
* And having at least one ore more of the following risk factors for postoperative AKI:

* Age =/>70 years
* Preoperative plasma creatinine >120 µmol/L New York Heart Association class III / IV or LVEF <35%
* Insulin dependent diabetes mellitus
* Valve surgery (with or without coronary artery bypass graft)
* Redo cardiac surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Cardiac surgical patients will not be considered eligible if:
* An emergency operation is indicated (within 24 hours after hospital admission or on intra-aortic balloon pump) or
* Pregnancy is confirmed or breastfeeding is present or
* A renal allograft is present or
* Preoperative acute renal failure within 6 weeks (acute rise in serum creatinine >50% from baseline) is present or
* Pre-operative end stage renal disease (serum creatinine >300 µmol/L) is present or
* Chronic moderate to high dose corticosteroid therapy (>10 mg/d prednisone or equivalent) is present

Study design
Purpose of the study
Prevention
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
1/05/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
350
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Ireland
State/province [3] 0 0
Dublin

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 Health, 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/NCT00672334