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

American Burn Association37 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Burns Hemofiltration Kidney Failure, Acute Shock, Septic

Interventions

An FDA approved continuous renal replacement deviceDEVICE

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

Control GroupOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Arizona Burn Center

Phoenix, Arizona, United States

The Burn Center at Washington Hospital Center

Washington D.C., District of Columbia, United States

Tampa General Hospital

Tampa, Florida, United States

Outcomes

Primary Outcomes

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)

Time frame: first 48 hours

Secondary Outcomes

PaO2/FiO2 ratio and Oxygenation index

Time frame: first 48 hours

Vasopressors-free days

Time frame: first 14 days

Survival

Time frame: 14 days, 28 days, and discharge

ICU days

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

Ventilator free days

Time frame: First 28 days after enrollment

Renal loss (need for long term renal replacement therapy)

Time frame: greater than 28 days

Data from ClinicalTrials.gov

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