NCT01213914

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: American Burn Association · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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	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

Timeline

• Start date: 2011-08-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2010-10-04
• Last updated: 2018-04-06

Locations

9 sites across 1 country: United States