Immediate renal replacement therapy: Renal replacement therapy started within 6 hours of randomization
Study summary
CAPITAL OFFLOAD-SHOCK will aim to answer if early use of renal replacement therapy, like dialysis, in patients with reduced body fluids causing the heart to be unable to pump enough blood through the body reduces in-hospital death when compared to the current standard of care. The current standard of care is to wait until renal replacement therapy is clinically necessary.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* adult patients \>/= 18 years of age admitted to an intensive care unit
* Diagnosed clinically with Society for Cardiovascular Angiography and Interventions (SCAI) Class C or D cardiogenic shock
* Clinical or hemodynamic evidence of volume overload
Exclusion Criteria:
* Patients whose care plan, as determined by the treating clinical team, will not include renal replacement therapy
* Decision has already been made by the treating clinical team to initiate renal replacement therapy
* Hyperkalemia with serum potassium \>/= 6mmol/L at the time of screening
* Severe metabolic acidosis with serum bicarbonate \</= 12 mmol/L at the time of screening
* Severe azotemia with serum urea \>/= 40 mmol/L at the time of screening
* Acute intoxication necessitating use of renal replacement therapy
* Recent renal replacement therapy (within 30 days)
* Known end-stage renal disease (defined as an estimated glomerular filtration rate \<15 ml/min/1.73m2
* presentation with out-of-hospital cardiac arrest
Primary outcome measure(s)
All cause mortality — Baseline to 90 days Occurrences of death from any cause
Increased serum lactate — Randomization to 24 hours post randomization. Serum lactate greater than 3.5 mmol/L between 6 and 24 hours after randomization
Mechanical circulatory support — Baseline to Hospital Discharge - expected up to 90 days New need for, or replacement of, a mechanical circulatory support device.
Resuscitated cardiac arrest — Baseline to Hospital Discharge - expected up to 90 days Occurrences of resuscitated cardiac arrest
Trial sites (1)
Facility
City
Region
Status
University of Ottawa Heart Institute
Ottawa
Ontario
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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