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

Primary Purpose

Burns, Hemofiltration, Kidney Failure, Acute

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

An FDA approved continuous renal replacement device

Control Group

About this trial

This is an interventional treatment trial for Burns focused on measuring Burns, Hemofiltration, Vasopressins, Kidney Failure Acute, Shock, Septic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arizona Burn Center
The Burn Center at Washington Hospital Center
Tampa General Hospital
Doctors Hospital-Joseph M Still Burn Center
Loyola University Medical Center
University of Kansas Hospital
Regional Medical Center at Memphis
University of Texas Southwestern Medical Center-Burn Center Parkland Health
US Army Institute of Surgical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-volume hemofiltration at 70ml/kg/hr

Control group

Arm 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

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.

Outcomes

Primary Outcome Measures

Vasopressor dependency index

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

Vasopressors-free days

Survival

ICU days

Ventilator free days

Renal loss (need for long term renal replacement therapy)

Full Information

NCT ID

NCT01213914

First Posted

September 30, 2010

Last Updated

April 5, 2018

Sponsor

American Burn Association

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01213914

Brief Title

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

Acronym

RESCUE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 2011 (undefined)

Primary Completion Date

September 2018 (Anticipated)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

American Burn Association

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-volume hemofiltration at 70ml/kg/hr

Arm Type

Experimental

Arm 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

Arm Title

Control group

Arm Type

Active Comparator

Arm 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.

Intervention Type

Device

Intervention Name(s)

An FDA approved continuous renal replacement device

Other Intervention Name(s)

High volume hemofiltration

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Control Group

Other Intervention Name(s)

Standard of care

Intervention Description

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

Primary Outcome Measure Information:

Title

Vasopressor dependency index

Description

Time Frame

first 48 hours

Secondary Outcome Measure Information:

Title

PaO2/FiO2 ratio and Oxygenation index

Time Frame

first 48 hours

Title

Vasopressors-free days

Time Frame

first 14 days

Title

Survival

Time Frame

14 days, 28 days, and discharge

Title

ICU days

Time Frame

Total number of days in ICU from date of Therapy Initiated through discharge

Title

Ventilator free days

Time Frame

First 28 days after enrollment

Title

Renal loss (need for long term renal replacement therapy)

Time Frame

greater than 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kevin K Chung, MD

Organizational Affiliation

United States Army Institute of Surgical Research

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Amy M Sprague, MD

Organizational Affiliation

Doctors Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Arizona Burn Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85008

Country

United States

Facility Name

The Burn Center at Washington Hospital Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

Tampa General Hospital

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Doctors Hospital-Joseph M Still Burn Center

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

Facility Name

Loyola University Medical Center

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

University of Kansas Hospital

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Regional Medical Center at Memphis

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38103

Country

United States

Facility Name

University of Texas Southwestern Medical Center-Burn Center Parkland Health

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

US Army Institute of Surgical Research

City

Fort Sam Houston

State/Province

Texas

ZIP/Postal Code

78234

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18492867

Citation

VA/NIH Acute Renal Failure Trial Network; Palevsky PM, Zhang JH, O'Connor TZ, Chertow GM, Crowley ST, Choudhury D, Finkel K, Kellum JA, Paganini E, Schein RM, Smith MW, Swanson KM, Thompson BT, Vijayan A, Watnick S, Star RA, Peduzzi P. Intensity of renal support in critically ill patients with acute kidney injury. N Engl J Med. 2008 Jul 3;359(1):7-20. doi: 10.1056/NEJMoa0802639. Epub 2008 May 20. Erratum In: N Engl J Med. 2009 Dec 10;361(24):2391.

Results Reference

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PubMed Identifier

9177886

Citation

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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

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