Renal Replacement Therapy for Cardiogenic Shock
(OFFLOAD-SHOCK Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether starting dialysis early can help people with cardiogenic shock, a condition where the heart can't pump enough blood due to reduced body fluids. Researchers aim to determine if early treatment reduces the risk of in-hospital death compared to waiting until dialysis is absolutely necessary. Participants will either receive dialysis within a few hours or undergo standard care, which delays dialysis until clearly needed. The trial seeks patients in intensive care with cardiogenic shock and signs of fluid overload. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.
What is the safety track record for immediate renal replacement therapy?
Research has shown that treatments like dialysis, which assist when kidneys fail, are usually well-tolerated by patients. Since dialysis already treats kidney failure, its general safety is well-established. Patients often find it manageable, with side effects that are typically mild and temporary, such as low blood pressure or cramps. This trial tests dialysis in a new way, but its safety is supported by its established use in other contexts.12345
Why are researchers enthusiastic about this study treatment?
Researchers are excited about immediate renal replacement therapy for cardiogenic shock because it offers a new approach that might provide faster intervention. Unlike the standard medical treatment, which typically delays renal replacement to only when it's medically necessary, this method involves starting the therapy within 2 to 6 hours of diagnosis. The hope is that this rapid response can stabilize patients more quickly, potentially improving outcomes by swiftly addressing the kidney's role in managing the shock. This could be a game-changer for those experiencing this critical condition.
What evidence suggests that immediate renal replacement therapy could be effective for cardiogenic shock?
Research has shown that starting kidney treatments like dialysis early can benefit patients with cardiogenic shock, where the heart fails to pump enough blood. In this trial, participants in the "Immediate Renal Replacement Therapy" arm will receive renal replacement therapy within 2-6 hours of randomization. One study found that early treatment reduced the 90-day death rate from 54.7% to 39.3%. Another study reported fewer hospital deaths with earlier kidney treatment. However, not all research agrees, as some studies did not find a survival benefit with early treatment. Overall, early intervention might improve outcomes, but results can vary.678910
Who Is on the Research Team?
Simon Parlow, MD, FRCPC
Principal Investigator
Ottawa Heart Institute Research Corporation
Are You a Good Fit for This Trial?
This trial is for adults in the ICU with heart failure causing poor blood flow and fluid overload, but who do not have severe kidney problems, dangerously high potassium or urea levels, recent dialysis, or certain other serious conditions. They must not already be set to start dialysis by their care team.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either immediate renal replacement therapy or standard medical treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Immediate renal replacement therapy
Trial Overview
The study compares starting dialysis (renal replacement therapy) early versus waiting until it's clearly needed in patients with cardiogenic shock and too much body fluid. Patients are randomly assigned to either approach.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receive renal replacement therapy within 2-6 hours of randomization.
Participants will receive the standard of care medical therapy with discouragement of renal replacement therapy unless medically necessary.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Heart Institute Research Corporation
Lead Sponsor
Citations
Acute renal replacement therapy in cardiogenic shock ...
Efficacy of Continuous Renal Replacement Therapy ... AKI has previously been associated with increased short-term mortality, whereas data on long-term outcomes ...
Outcome of patients treated with renal replacement therapy for ...
Over a 10-year period, 1330 ICU patients had AKI-RRT. Results per year are presented in Table 1. Outcome improved (hazard ratio [HR] [/year] = 0.95 [0.93–0.98], ...
Early Treatment for Acute Kidney Injury Improves Outcomes
At 90 days, the mortality rate was lower in the early group than in the delayed group (39.3% vs 54.7%; P = .03), and the absolute risk reduction ...
Accelerated versus delayed initiation of renal-replacement ...
The primary end point of death at 90 days was similar between groups (43.9% vs 43.7%, P = .92). Prolonged RRT was observed at greater rates in ...
Using continuous renal replacement therapy to manage ...
Using continuous renal replacement therapy to manage patients of shock and acute renal failure ... Cardiogenic shock, 10. B. Pulmonary thromboembolism, 2. C.
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