Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
United States Army Institute of Surgical Research
Tampa General Hospital
Washington Hospital Center
Loyola University
University of Texas Southwestern Medical Center
Maricopa Integrated Health System
University of Tennessee Health Science Center
University of Kansas Medical Center
Doctors Hospital-Joseph M Still Burn Center
Information provided by (Responsible Party):
United States Army Institute of Surgical Research ( American Burn Association )
ClinicalTrials.gov Identifier:
NCT01213914
First received: September 30, 2010
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention
Burns
Hemofiltration
Kidney Failure, Acute
Shock, Septic
Device: An FDA approved continuous renal replacement device
Other: Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The American Burn Association's Randomized Controlled Evaluation of Hemofiltration in Adult Burn Patients With Septic Shock and Acute Renal Failure

Resource links provided by NLM:


Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • Vasopressor dependency index [ Time Frame: first 48 hours ] [ Designated as safety issue: No ]

    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)



Secondary Outcome Measures:
  • PaO2/FiO2 ratio and Oxygenation index [ Time Frame: first 48 hours ] [ Designated as safety issue: No ]
  • Vasopressors-free days [ Time Frame: first 14 days ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 14 days, 28 days, and discharge ] [ Designated as safety issue: No ]
  • ICU days [ Time Frame: Total number of days in ICU from date of Therapy Initiated through discharge ] [ Designated as safety issue: No ]
  • Ventilator free days [ Time Frame: First 28 days after enrollment ] [ Designated as safety issue: No ]
  • Renal loss (need for long term renal replacement therapy) [ Time Frame: greater than 28 days ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: August 2011
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Standard of care

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213914

Locations
United States, Arizona
Arizona Burn Center
Phoenix, Arizona, United States, 85008
United States, District of Columbia
The Burn Center at Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
Doctors Hospital-Joseph M Still Burn Center
Augusta, Georgia, United States, 30909
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Kansas
University of Kansas Hospital
Kansas City, Kansas, United States, 66160
United States, Tennessee
Regional Medical Center at Memphis
Memphis, Tennessee, United States, 38103
United States, Texas
University of Texas Southwestern Medical Center-Burn Center Parkland Health
Dallas, Texas, United States, 75235
US Army Institute of Surgical Research
JBSA Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
American Burn Association
United States Army Institute of Surgical Research
Tampa General Hospital
Washington Hospital Center
Loyola University
University of Texas Southwestern Medical Center
Maricopa Integrated Health System
University of Tennessee Health Science Center
University of Kansas Medical Center
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
  More Information

Publications:

Responsible Party: American Burn Association
ClinicalTrials.gov Identifier: NCT01213914     History of Changes
Other Study ID Numbers: H-09-046  W81XWH-09-2-0194  Combat Casualty Grant 
Study First Received: September 30, 2010
Last Updated: November 1, 2016
Health Authority: United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:
Burns
Hemofiltration
Vasopressins
Kidney Failure Acute
Shock, Septic

Additional relevant MeSH terms:
Acute Kidney Injury
Shock
Burns
Renal Insufficiency
Shock, Septic
Pathologic Processes
Wounds and Injuries
Kidney Diseases
Urologic Diseases
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on December 07, 2016