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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: An FDA approved continuous renal replacement device
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-volume hemofiltration at 70ml/kg/hr<br>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<br>* 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<br>* Other names: High volume hemofiltration;|
| Active Comparator: Control group<br>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<br>* 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<br>* Other names: Standard of care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | first 48 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burns, Hemofiltration, Vasopressins, Kidney Failure Acute, Shock, Septic