The American Burn Associations Randomized controlled Evaluation of hemofiltration in adult burn patients with Septic shock and acute renal failure

Study ID
STU 022011-018

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Agnes Burris
214-648-3521
agnes.burris@utsouthwestern.edu

Principal Investigator
Brett Arnoldo

Summary

This is an interventional multicenter randomized controlled study. Patients will be randomized to therapy (with HVHF) in addition to `contemporary' care or 'contemporary' care only. The window for subject enrollment will be 24-hours after inclusion criteria have been met.
in order to not delay the initiation of therapy while informed consent is being obtained, subjects who meet local indications for initiation of renal replacement will be permitted to receive one hemodialysis treatment or up to 24-hours of CRRT prior to enrollment and randomization.

Primary endpoint
The primary endpoint for this study is the change in mean arterial pressure and vasopressor requirement at 48 hours. These same primary endpoints were utilized in a recent randomized controlled study assessing the use of Polymyxin B Hemoperfusion in septic shock. The following calculations will be performed to measure these outcomes.
Mean arterial Pressure (mmHg)
Modified inotropic index [?] (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
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.
Secondary endpoints
Secondary endpoints will include Pa021Fi02 ratio, oxygenation index, vasopressors-free days in the first 14 days. Survival at 14 days, 28 days and to discharge, iCu days, hospital days, ventilator-free days in the first 28 days after enrollment, and renal loss (need for long term RRT x greater than 28 days)

Participant Eligibility


* All adult patients admitted to the burn ICU with burns of any size

* Acute renal failure as previously defined by the VA/NIH ATN study investigators(2)

* Septic shock >48 hours after admission.

* Patients 18 or older

* Patient/legally authorized representative willing to provide consent