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

April 5, 2018 updated by: American Burn Association

The American Burn Association's Randomized Controlled Evaluation of Hemofiltration in Adult Burn Patients With Septic Shock and Acute Renal Failure

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Arizona Burn Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • The Burn Center at Washington Hospital Center
    • Florida
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Doctors Hospital-Joseph M Still Burn Center
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Regional Medical Center at Memphis
    • Texas
      • Dallas, Texas, United States, 75235
        • University of Texas Southwestern Medical Center-Burn Center Parkland Health
      • Fort Sam Houston, Texas, United States, 78234
        • US Army Institute of Surgical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-volume hemofiltration at 70ml/kg/hr
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
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 Names:
  • High volume hemofiltration
Active Comparator: Control group
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.
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
Other Names:
  • Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vasopressor dependency index
Time Frame: first 48 hours

Vasopressor dependency index = MAP/Inotropic score • This index will correct for the inter-center variability that exists with regards to the point (minimum MAP) at which vasopressors are initiated or weaned off. Thus, this eliminates the need to 'standardize' starting/stopping criteria of vasopressors.

Modified Inotropic index (30) = (dopamine dose X1)+(dobutamine dose X1)+(epi doseX100)+(norepi doseX100)+(phenylephrine doseX100)+(vasopressin doseX100)

• All units recorded at each time point in mcg/kg/min

Mean Arterial Pressure (mmHg)
first 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
PaO2/FiO2 ratio and Oxygenation index
Time Frame: first 48 hours
first 48 hours
Vasopressors-free days
Time Frame: first 14 days
first 14 days
Survival
Time Frame: 14 days, 28 days, and discharge
14 days, 28 days, and discharge
ICU days
Time Frame: Total number of days in ICU from date of Therapy Initiated through discharge
Total number of days in ICU from date of Therapy Initiated through discharge
Ventilator free days
Time Frame: First 28 days after enrollment
First 28 days after enrollment
Renal loss (need for long term renal replacement therapy)
Time Frame: greater than 28 days
greater than 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Burn Association

Collaborators

University of Kansas Medical Center
University of Texas Southwestern Medical Center
University of Tennessee
Medstar Health Research Institute
Valleywise Health
Loyola University
Tampa General Hospital
United States Army Institute of Surgical Research
Doctors Hospital-Joseph M Still Burn Center

Investigators

  • Study Chair: Kevin K Chung, MD, United States Army Institute of Surgical Research
  • Study Director: Amy M Sprague, MD, Doctors Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

September 30, 2010

First Submitted That Met QC Criteria

October 1, 2010

First Posted (Estimate)

October 4, 2010

Study Record Updates

Last Update Posted (Actual)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-09-046
  • W81XWH-09-2-0194 (Other Grant/Funding Number: U.S. Army Medical Research and Materiel Command)
  • Combat Casualty Grant (Other Identifier: American Burn Association)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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