Renal Replacement Therapy for Cardiogenic Shock

(OFFLOAD-SHOCK Trial)

HF
Overseen ByHannah Feagan, RN
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Ottawa Heart Institute Research Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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?

SP

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

I am 18 or older and have been admitted to an intensive care unit.
I have signs or symptoms of fluid overload in my body.
I have been diagnosed with severe cardiogenic shock (SCAI Class C or D).

Exclusion Criteria

Severe metabolic acidosis with serum bicarbonate 12 mmol/L or lower at the time of screening
Hyperkalemia with serum potassium 6 mmol/L or higher at the time of screening
Severe azotemia with serum urea 40 mmol/L or higher at the time of screening
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either immediate renal replacement therapy or standard medical treatment

Up to 90 days
Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 90 days

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

Group I: Immediate Renal Replacement TherapyExperimental Treatment1 Intervention
Group II: Standard Medical TreatmentActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials
200
Recruited
95,800+

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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