The American Burn Association's Randomized Controlled Evaluation of Hemofiltration in Adult Burn Patients With Septic Shock and Acute Renal Failure
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- American Burn Association
- Enrollment
- 37
- Locations
- 18
- Primary Endpoint
- Vasopressor dependency index
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
High-volume hemofiltration at 70ml/kg/hr
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
Intervention: An FDA approved continuous renal replacement device (Device)
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.
Intervention: Control Group (Other)
Outcomes
Primary Outcomes
Vasopressor dependency index
Time Frame: 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 Outcomes
- PaO2/FiO2 ratio and Oxygenation index(first 48 hours)
- Vasopressors-free days(first 14 days)
- Renal loss (need for long term renal replacement therapy)(greater than 28 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)