Burns, Hemofiltration, Kidney Failure, Acute, Shock, Septic
Conditions
Keywords
Burns, Hemofiltration, Vasopressins, Kidney Failure Acute, Shock, Septic
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.
Interventions
DEVICEAn 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
OTHERControl 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
Sponsors
United States Army Institute of Surgical Research
Tampa General Hospital
Medstar Health Research Institute
Loyola University
University of Texas Southwestern Medical Center
Valleywise Health
University of Tennessee
University of Kansas Medical Center
Doctors Hospital-Joseph M Still Burn Center
American Burn Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| ICU days | Total number of days in ICU from date of Therapy Initiated through discharge |
| Ventilator free days | First 28 days after enrollment |
| Survival | 14 days, 28 days, and discharge |
Countries
United States
Outcome results
None listed