Acute Kidney Injury Clinical Trial
Official title:
A Phase IIb Multiple Blind Randomized Controlled Trial of Sodium Bicarbonate in Cardiac Surgery at High-risk of Acute Kidney Injury
With over one million operations a year, cardiac surgery with cardiopulmonary bypass is one
of the most common major surgical procedures worldwide (1). Acute kidney injury is a common
and serious postoperative complication of cardiopulmonary bypass and may affect 25% to 50%
of patients (2-4). Acute kidney injury carries significant costs (4) and is independently
associated with increased morbidity and mortality (2,3). Even minimal increments in plasma
creatinine are associated with an increase in mortality (5,6).
Multiple causes of cardiopulmonary bypass-associated acute kidney injury have been proposed,
including ischemia-reperfusion, generation of reactive oxygen species, hemolysis and
activation of inflammatory pathways (7-10). To date, no simple, safe and effective
intervention to prevent cardiopulmonary bypass-associated acute kidney injury in a broad
patient population has been found (11-14).
Urinary acidity may enhance the generation and toxicity of reactive oxygen species induced
by cardiopulmonary bypass (10,15). Activation of complement during cardiac surgery (16) may
also participate in kidney injury. Urinary alkalinization may protect from kidney injury
induced by oxidant substances, iron-mediated free radical pathways, complement activation
and tubular hemoglobin cast formation (9,17,18). Of note, increasing urinary pH - in
combination with N-acetylcysteine (19,20) or without (21) - has recently been reported to
attenuate acute kidney injury in patients undergoing contrast-media infusion.
In a pilot double-blind, randomized controlled trial the investigators found sodium
bicarbonate to be efficacious, safe, inexpensive and easy to administer. These findings now
need to be confirmed or refuted by further clinical investigations in other geographic and
institutional settings.
Accordingly, the investigators hypothesized that urinary alkalinization might protect kidney
function in patients at increased risk of acute kidney injury undergoing cardiopulmonary
bypass needs to be confirmed in an international multicenter, double-blind, randomized
controlled trial of intravenous sodium bicarbonate.
Status | Terminated |
Enrollment | 427 |
Est. completion date | January 2012 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 70 Years and older |
Eligibility |
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 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Austin Hospital | Melbourne | Victoria |
Australia | Warringal Private Hospital | Melbourne | Victoria |
New Zealand | Auckland City Hospital | Auckland | |
New Zealand | Waikato Hospital | Hamilton |
Lead Sponsor | Collaborator |
---|---|
Austin Health |
Australia, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | within first five postoperative days | No | |
Secondary | Mean changes in serum creatinine after adjustment for relevant baseline variables | within first five postoperative days | No | |
Secondary | mean changes in serum cystatin C after adjustment for relevant baseline variables | within first five postoperative days | No | |
Secondary | mean changes in urinary neutrophil gelatinase-associated lipocalin (NGAL)after adjustment for relevant baseline variables | within first five postoperative days | No | |
Secondary | Duration of ventilation | Until time of extubation from mechanical ventilation | No | |
Secondary | Proportion of patients developing any of the RIFLE criteria: R, I or F | within first five postoperative days | No | |
Secondary | Incidence of post-operative atrial fibrillation | within first five postoperative days | No | |
Secondary | Duration of stay in the intensive care unit (ICU) | from admission to the ICU | No | |
Secondary | Duration of stay in hospital | from admission to discharge from hospital | No | |
Secondary | 90-day mortality | during 90 days postoperatively | No | |
Secondary | Change in electrolyte status from baseline to peak | within first 24-48hrs postoperatively | Yes |
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