Capital Offload-Shock

Phase 4Not Yet RecruitingNCT07756801

Ottawa Heart Institute Research Corporation456 enrolled

Overview

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.

The trial will evaluate the in-hospital mortality between starting renal replacement therapy (RRT) immediately upon confirmation of eligibility and consent and using standard medical therapy without RRT unless one of the following occurs: 1) clinical volume overload refractory to diuresis with high-dose intravenous furosemide plus either thiazide-like diuretic and/or acetazolamide, resulting in pulmonary edema, necessitation ventilation with FiO2 \> 50%, 2) hyperkalemia with serum potassium \>6mmol/L, or 3) severe metabolic acidosis with pH \<7.20 and bicarb \<=12 mmol/L thought to be due to renal insufficiency.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

456

Conditions

Hypervolemia Cardiogenic Shock Renal Replacement Therapies

Interventions

Immediate renal replacement therapyDRUG

Renal replacement therapy started within 6 hours of randomization

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

All cause mortality

Occurrences of death from any cause

Time frame: Baseline to 90 days

Increased serum lactate

Serum lactate greater than 3.5 mmol/L between 6 and 24 hours after randomization

Time frame: Randomization to 24 hours post randomization.

Mechanical circulatory support

New need for, or replacement of, a mechanical circulatory support device.