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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by United States Army Institute of Surgical Research
Sponsor:
Collaborators:
United States Army Institute of Surgical Research
The University of Texas Health Science Center, Houston
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 Burnett Burn Center
Joseph M. Stills 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: March 6, 2014
Last verified: March 2014
  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: length of hospital stay ] [ 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 ]

Estimated Enrollment: 120
Study Start Date: August 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2014 (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
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

Contacts
Contact: Kevin K Chung, MD 210-916-1133 Kevin.k.chung.mil@mail.mil
Contact: Elsa C Coates, MS, RN, CCRN 210-916-6186 Elsa.c.coates.civ@mail.mil

Locations
United States, Arizona
Arizona Burn Center Recruiting
Phoenix, Arizona, United States, 85008
Contact: Daniel M Caruso, MD    602-344-5624    caruso@medprodoctors.com   
Contact: Karen J Richey, RN    602-344-6125    karen.richey@mihs.org   
Principal Investigator: Daniel M Caruso, MD         
United States, District of Columbia
The Burn Center at Washington Hospital Center Recruiting
Washington D.C., District of Columbia, United States, 20010
Contact: Laura S Johnson, MD    202-877-7259    laura.s.johnson@medstar.net   
Contact: Brittany N Hamilton    202-877-6181    brittany.n.hamilton@medstar.net   
Principal Investigator: Laura S Johnson, MD         
United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: David Smith, MD    813-259-0924    Dsmith3@health.usf.edu   
Contact: Rachel Karlnoski, PhD    813-844-4413    rkarlnoski@fgtba.com   
Principal Investigator: David Smith, MD         
United States, Georgia
Joseph M. Still Burn Center Recruiting
Augusta, Georgia, United States, 30909
Contact: Amy Sprague, MD    706-364-2966    asprague@msn.com   
Principal Investigator: Amy Sprague, MD         
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Richard L Gameli, MD    708-216-9222    rgamell@lumc.edu   
Contact: Marcia M Halerz, BSN, RN    708-327-2457    mhalerz@lumc.edu   
Principal Investigator: Richard L Gamelli, MD         
Sub-Investigator: Michael Mosier, MD         
United States, Kansas
University of Kansas Hospital Recruiting
Kansas City, Kansas, United States, 66160
Contact: James M Howard, MD    913-588-6265    jhoward3@kumc.edu   
Contact: Douglas Ross, RN, BSN    913-588-0068    dross6@kumc.edu   
Principal Investigator: James Howard, MD         
United States, Tennessee
Regional Medical Center at Memphis Recruiting
Memphis, Tennessee, United States, 38103
Contact: William L Hickerson, MD    901-448-2579    bhickerson@mac.com   
Contact: Angela Arnold-Ross, RN    901-448-2579    aarnold@uthsc.edu   
United States, Texas
University of Texas Southwestern Medical Center-Burn Center Parkland Health Recruiting
Dallas, Texas, United States, 75235
Contact: Brett Arnoldo, MD    214-648-5430    Brett.arnoldo@utsouthwestern.edu   
Contact: Agnes Burris, RN    214-648-3521    Agnes.burris@utsouthwestern.edu   
Principal Investigator: Brett Arnoldo, MD         
University of Texas Health Science Center, Houston Recruiting
Houston, Texas, United States, 77030
Contact: Kevin W Finkel, MD    713-500-7200    Kevin.W.Finkel@uth.tmc.edu   
Contact: Beatriz Efton, RN, BSN    713-500-6868    Beatriz.efron@uth.tmc.edu   
US Army Institute of Surgical Research Recruiting
JBSA Fort Sam Houston, Texas, United States, 78234
Contact: Kevin K Chung, MD, FACP    210-916-1133    kevin.k.chung.mil@mail.mil   
Contact: Elsa C Coates, MSN, RN, CCRN    210-916-6186    elsa.c.coates.civ@mail.mil   
Principal Investigator: Kevin K Chung, MD, FACS         
Sponsors and Collaborators
American Burn Association
United States Army Institute of Surgical Research
The University of Texas Health Science Center, Houston
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 Burnett Burn Center
Joseph M. Stills Burn Center
Investigators
Study Chair: Kevin K Chung, MD United States Army Institute of Surgical Research
Study Director: Amy M Sprague, MD Dwight D Eisenhower Army Medical Center
  More Information

Publications:

Responsible Party: United States Army Institute of Surgical Research ( 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: March 6, 2014
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:
Burns
Acute Kidney Injury
Renal Insufficiency
Shock
Shock, Septic
Wounds and Injuries
Kidney Diseases
Urologic Diseases
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on August 19, 2014