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

Not Applicable

• Conditions: Burns; Kidney Failure, Acute; Hemofiltration; Shock, Septic
• Interventions: Device: An FDA approved continuous renal replacement device; Other: Control Group

• Registration Number: NCT01213914
• Lead Sponsor: American Burn Association

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.

Study Timeline

• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-04
• Study Start: 2011-08
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-volume hemofiltration at 70ml/kg/hr	An FDA approved continuous renal replacement device	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
Control group	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.

Primary Outcome Measures

Name	Time	Method
Vasopressor dependency index	first 48 hours	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

Name	Time	Method
Vasopressors-free days	first 14 days
Renal loss (need for long term renal replacement therapy)	greater than 28 days
PaO2/FiO2 ratio and Oxygenation index	first 48 hours
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

Trial Locations

Locations (9)

Doctors Hospital-Joseph M Still Burn Center; 🇺🇸 Augusta, Georgia, United States

University of Texas Southwestern Medical Center-Burn Center Parkland Health; 🇺🇸 Dallas, Texas, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

US Army Institute of Surgical Research; 🇺🇸 Fort Sam Houston, Texas, United States

The Burn Center at Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Regional Medical Center at Memphis; 🇺🇸 Memphis, Tennessee, United States

University of Kansas Hospital; 🇺🇸 Kansas City, Kansas, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Arizona Burn Center; 🇺🇸 Phoenix, Arizona, United States