Hemofiltration in Burns: RESCUE (Randomized Controlled Evaluation of Hemofiltration in Adult Burn Patients With Septic Shock and Acute Renal Failure)

American Burn Association

Status: Unknown

Conditions: Kidney Failure, Acute; Shock, Septic; Burns; Hemofiltration

Treatments: Device: An FDA approved continuous renal replacement device; Other: Control Group

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01213914

Combat Casualty Grant (Other Identifier)

H-09-046

W81XWH-09-2-0194 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is determine if High-Volume Hemofiltration in addition to 'contemporary' care will result in an improvement of select clinical outcomes when compared to 'contemporary' care alone in the treatment of critically ill patients with ARF secondary to septic shock.

Full description

Acute renal failure (ARF) is a common and devastating complication in critically ill burn patients with mortality reported to be between 80 and 100%.(3-7) Despite recent advances in burn care, the unacceptably high mortality rate in this subgroup has not changed over time. The pathogenesis of ARF in burns, similar to other critically ill populations, is often multi-factorial with one major component being sepsis induced ischemic tubular necrosis. Thus, ARF secondary to septic shock is a common and devastating condition in the burn ICU.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All adult patients admitted to the burn intensive care unit (ICU) with burns of any size
• Acute renal failure as previously defined by the Veterans Affairs/ National Institutes of Health (VA/NIH) Acute Renal Failure Trial Network study investigators(2)
• Patient is > 48 hours post-burn and in Septic Shock
• Patients 18 or older
• Patient/legally authorized representative willing to provide consent

Exclusion criteria

• Age <18
• Non-thermal injury (exfoliating skin disorders or necrotizing fasciitis)
• Pre-admission diagnosis of end stage renal failure
• Patients already on renal replacement therapy for more than 24 hours
• Patient not expected to survive more than 24 hours after randomization.
• Pregnancy
• Prisoners

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

High-volume hemofiltration at 70ml/kg/hr

Experimental group

Description:

Paired randomization into four groups via central randomization center. Group 1: age 18-65 and \<40%TBSA Group 2: age 18-65 and \>40%TBSA Group 3: age \>65 and \<40%TBSA Group 4: age \>65 and \>40%TBSA

Treatment:

Device: An FDA approved continuous renal replacement device

Control group

Active Comparator group

Description:

Contemporary care via consideration of the Burn-Specific Sepsis Bundle adapted form the most recent Surviving Sepsis campaign recommendations and specifically modified to our patient population.

Treatment:

Other: Control Group