Washington Study of Hemofiltration After Out-of-Hospital Cardiac Arrest

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

November 30, 2013

Study Completion Date

June 30, 2014

Conditions
Cardiac Arrest
Interventions
OTHER

Standard Care

"Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.~Initiation and maintenance of therapeutic hypothermia, target core temperature of below 34°C via standard external cooling techniques.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."

DEVICE

Low Volume Hemofiltration

"Patients will receive isovolemic HF at a blood flow rate of 250 mL/min and ultrafiltration rate of 45 mL/kg/h for 48 hours. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."

DEVICE

High Volume Hemofiltration

"Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."

Trial Locations (1)

98040

Harborview Medical Center, Seattle

All Listed Sponsors
lead

University of Washington

OTHER

NCT01509040 - Washington Study of Hemofiltration After Out-of-Hospital Cardiac Arrest | Biotech Hunter | Biotech Hunter