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

Summary

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.

Conditions

• Burns
• Hemofiltration
• Kidney Failure, Acute
• Shock, Septic

Interventions

DEVICE

An FDA approved continuous renal replacement device

70ml/kg/hr for treatment group for 48 hours with the following requirements: * double lumen dialysis catheter should be placed in the internal jugular or femoral vein * Anticoagulation will be determined by prescribing physician * Use of 1.4 m2 or larger biocompatible synthetic hollow-fiber dialysis membrane that is changed every 24 hours * Blood flow rate will be set to ensure a filtration fraction of no more than 25% * Monitoring for electrolytes (specifically K+, Mg, Ca, and phos) during HVHF must be performed at least every 6 hours * Replacement fluids will be bicarbonate-buffered with appropriate adjustments when citrate-anticoagulation is utilized * All antibiotics will be dose adjusted for renal replacement therapy

OTHER

Control Group

Both groups will receive 'contemporary' care via consideration of the Burn-specific Sepsis Bundle adapted from the most recent Surviving Sepsis Campaign (SSC) (1) recommendations and specifically modified to our patient population

Sponsors & Collaborators

• United States Army Institute of Surgical Research

  collaborator FED

• Tampa General Hospital

  collaborator OTHER

• Medstar Health Research Institute

  collaborator OTHER

• Loyola University

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• Valleywise Health

  collaborator OTHER

• University of Tennessee

  collaborator OTHER

• University of Kansas Medical Center

  collaborator OTHER

• Doctors Hospital-Joseph M Still Burn Center

  collaborator UNKNOWN

• American Burn Association

  lead OTHER

Principal Investigators

• Kevin K Chung, MD · United States Army Institute of Surgical Research

• Amy M Sprague, MD · Doctors Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-08-31

Primary Completion

2018-09-30

Completion

2018-09-30

Countries

• United States

Study Locations