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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00334191




Registration number
NCT00334191
Ethics application status
Date submitted
5/06/2006
Date registered
6/06/2006
Date last updated
7/07/2009

Titles & IDs
Public title
Sodium Bicarbonate in Cardiac Surgery
Scientific title
A Randomised, Double Blind, Placebo Controlled Pilot Study of the Effect of Sodium Bicarbonate on Postoperative Renal Function and Oxidative Stress in Patients Undergoing Elective Cardiopulmonary Bypass.
Secondary ID [1] 0 0
H2005/02249
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients developing an increase in serum creatinine greater than 25% from baseline to peak level within first five postoperative days.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Proportion of patients developing an increase in serum creatinine greater than 50% from baseline to peak level within first five postoperative days.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Relative change in serum creatinine,
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Urinary output,
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Use of renal replacement therapy (RRT),
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Acute renal dysfunction,
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Duration of ventilation,
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Chest tube drainage,
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Need for return to operating room,
Timepoint [8] 0 0
Secondary outcome [9] 0 0
Incidence of post-operative atrial fibrillation (AF),
Timepoint [9] 0 0
Secondary outcome [10] 0 0
Duration of stay in the intensive care unit (ICU)
Timepoint [10] 0 0
Secondary outcome [11] 0 0
Duration of stay in hospital
Timepoint [11] 0 0

Eligibility
Key inclusion criteria
* Age above 70 years
* Preexisting renal impairment (preoperative serum creatinine level >120µmol/L
* New York Heart Association class III/IV or Moderate to poor left ventricular dysfunction
* Valve surgery or complex cardiac surgery
* Redo cardiac surgery
* Insulin-dependent diabetes mellitus
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Age <18 years
* Emergency cardiac surgery
* Planned off-pump cardiac surgery
* Enrolled in conflicting research study
* Known blood-borne infectious disease
* Chronic inflammatory disease on immunosuppression
* Chronic moderate to high dose corticosteroid therapy (>10mg/d prednisone or equivalent)
* End stage renal disease (serum creatinine >300µmol/L)
* Thiamine deficiency will be excluded on medical and dietary history.

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?



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
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
Many patients develop kidney failure after cardiac surgery. Although this kidney failure can usually be treated effectively, a longer stay in intensive care is often required. While many patients suffer no long term ill effects after developing post-operative kidney failure, some require long term kidney dialysis. We also know that patients who develop post-operative kidney failure are much more likely to die before they leave hospital.

Why some people develop kidney failure after cardiac surgery is not known. However, doctors suspect that the process of cardiopulmonary bypass (where the functions of the heart and lungs are taken over by a machine during the operation, to allow the surgeon to operate) overactivates some of the same mechanisms the body uses to defend itself against severe infection.

Many of the cell changes by which severe infection causes kidney failure also occur after cardiopulmonary bypass. One of the main overactive defence mechanisms is the release of highly toxic compounds derived from oxygen - a process called 'oxidative stress'.

The investigators believe that sodium bicarbonate might reduce the oxidative stress, which occurs during cardiac surgery, and so prevent or decrease the kidney failure, which occurs in many patients.

The investigators hope to give sodium bicarbonate (in similar doses to those used safely for treatment of acidosis) to patients during, and for 24 hours after cardiac surgery, and to compare the effects with patients who have not had sodium bicarbonate. The drug, or a placebo, will be given through the drip, which is present in all cardiac surgery patients. Whether a particular patient receives the drug or placebo will be decided at random, and neither the patient nor the investigators will know which has been given. We will measure kidney function before and after the operation using the standard blood tests.

The investigators will also take four 20ml samples of blood, spaced before, during, and after the operation, from the arterial catheter routinely inserted in every patient. This blood would be used to measure oxidative stress, and also some of the proteins inside the blood cells, which are responsible for creating the toxic oxygen compounds. In this way we will discover not only the effect of sodium bicarbonate, but also the mechanism of that effect.

Sodium bicarbonate is commonly used to treat metabolic acidosis in severe renal disease, circulatory insufficiency due to shock or severe dehydration and has been shown to be an effective drug in preventing contrast-induced nephropathy.

Sodium bicarbonate is considered to be safe in the setting of intensive care treatment and is often used in the treatment of patients with metabolic acidosis without any discernible adverse clinical effects.

This is a pilot study. If the drug proves effective in this context, further studies on a larger scale would be required to justify its general use.

There will be no extra risk to a patient who participates in the study, and no discomfort other than that normally associated with cardiac surgery.

Informed consent will be obtained from the patient prior to the operation by one of the investigators or the ICU research nurse. The clinical care of a patient who does not consent for any reason will not be affected.
Trial website
https://clinicaltrials.gov/study/NCT00334191
Trial related presentations / publications
Haase M, Haase-Fielitz A, Bellomo R, Devarajan P, Story D, Matalanis G, Reade MC, Bagshaw SM, Seevanayagam N, Seevanayagam S, Doolan L, Buxton B, Dragun D. Sodium bicarbonate to prevent increases in serum creatinine after cardiac surgery: a pilot double-blind, randomized controlled trial. Crit Care Med. 2009 Jan;37(1):39-47. doi: 10.1097/CCM.0b013e318193216f.
Haase M, Haase-Fielitz A, Ratnaike S, Reade MC, Bagshaw SM, Morgera S, Dragun D, Bellomo R. N-Acetylcysteine does not artifactually lower plasma creatinine concentration. Nephrol Dial Transplant. 2008 May;23(5):1581-7. doi: 10.1093/ndt/gfm818. Epub 2008 Jan 17.
Public notes

Contacts
Principal investigator
Name 0 0
Rinaldo Bellomo, MD, FRACP
Address 0 0
Austin Health
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/study/NCT00334191