Trial Outcomes & Findings for Washington Study of Hemofiltration After Out-of-Hospital Cardiac Arrest (NCT NCT01509040)

NCT ID: NCT01509040

Last Updated: 2016-06-09

Results Overview

Intervention Compliance will be defined as the proportion of intervention patients who are alive and undergo hemofiltration (HF) for at least 80% of 48 hours from randomization.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2016-06-09

Participant Flow

Participant milestones

Measure	Control Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. 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.	Low Volume Hemofiltration Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. 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.	High Volume Hemofiltration High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . 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.
Overall Study STARTED	0	2	0
Overall Study COMPLETED	0	1	0
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Control Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. 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.	Low Volume Hemofiltration n=2 Participants Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. 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.	High Volume Hemofiltration High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . 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.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 participants n=7 Participants	—	0 participants n=4 Participants
Age, Categorical Between 18 and 65 years	—	0 participants n=7 Participants	—	0 participants n=4 Participants
Age, Categorical >=65 years	—	2 participants n=7 Participants	—	2 participants n=4 Participants
Age, Continuous	—	67 years n=7 Participants	—	67 years n=4 Participants
Gender Female	—	1 participants n=7 Participants	—	1 participants n=4 Participants
Gender Male	—	1 participants n=7 Participants	—	1 participants n=4 Participants
Region of Enrollment United States	—	2 participants n=7 Participants	—	2 participants n=4 Participants

PRIMARY outcome

Timeframe: 48 hours

Intervention Compliance will be defined as the proportion of intervention patients who are alive and undergo hemofiltration (HF) for at least 80% of 48 hours from randomization.

Outcome measures

Measure	Control Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. 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.	Low Volume Hemofiltration n=2 Participants Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. 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.	High Volume Hemofiltration High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . 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.
Intervention Compliance	—	1 participants	—

SECONDARY outcome

Timeframe: 12 hours

This will be defined as the proportion of eligible patients who are randomized.

Outcome measures

Measure	Control Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. 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.	Low Volume Hemofiltration n=2 Participants Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. 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.	High Volume Hemofiltration High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . 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.
Enrollment	—	2 participants	—

SECONDARY outcome

Timeframe: 48 hours

Population: The outcome was not assessed.

Venous blood samples will be obtained periodically after randomization, processed, stored, then tested for serum cytokine levels.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours

This will be defined as the volume of fluid (in mL) infused during the first 48 hours from enrollment.

Outcome measures

Measure	Control Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. 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.	Low Volume Hemofiltration n=2 Participants Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. 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.	High Volume Hemofiltration High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . 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.
Total Volume Intravenous Fluid Infused	—	10652.5 mL Interval 8043.0 to 13262.0	—

SECONDARY outcome

Timeframe: 48 hours

This includes use of dopamine, dobutamine, epinephrine, nesiritide, norepinephrine, or phenylephrine during the first 48 hours from enrollment.

Outcome measures

Measure	Control Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. 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.	Low Volume Hemofiltration n=2 Participants Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. 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.	High Volume Hemofiltration High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . 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.
Use of Pressors and Inotropes	—	1 participants	—

SECONDARY outcome

Timeframe: 48 hours

This will be defined as systolic blood pressure < 65 at the end of any four hour period during the initial 48 hours of enrollment in control and intervention patients.

Outcome measures

Measure	Control Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. 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.	Low Volume Hemofiltration n=2 Participants Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. 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.	High Volume Hemofiltration High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . 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.
Shock	—	0 participants	—

SECONDARY outcome

Timeframe: 48 hours

This will be assessed by standard transthoracic echocardiographic methods 48 hours after enrollment in control and intervention patients

Outcome measures

Measure	Control Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. 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.	Low Volume Hemofiltration n=2 Participants Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. 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.	High Volume Hemofiltration High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . 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.
Ejection Fraction	—	65 percentage Interval 55.0 to 75.0	—

SECONDARY outcome

Timeframe: 6 months

This will be described for all hospitalized patients as a measure of morbidity after resuscitation.

Outcome measures

Measure	Control Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. 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.	Low Volume Hemofiltration n=2 Participants Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. 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.	High Volume Hemofiltration High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . 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.
Number of Hospital Days	—	8.5 days Interval 2.0 to 15.0	—

SECONDARY outcome

Timeframe: 1 year

This will be described for all hospitalized patients as a measure of morbidity after resuscitation.

Outcome measures

Measure	Control Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. 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.	Low Volume Hemofiltration n=2 Participants Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. 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.	High Volume Hemofiltration High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . 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.
Time Interval From 911 Call to Patient Death	—	183.6 Days Interval 2.2 to 365.0	—

SECONDARY outcome

Timeframe: 48 hours

Device-Related Hematoma at insertion site, vessel perforation, wound infection, deep venous thrombosis or pulmonary embolism.

Device Failure Mechanical failure Hypertension- SBP>160 mmHg, or DBP >120 mmHg. Hypotension- SBP<60 mmHg. Hypervolemia- CVP > 12 cm. Hypovolemia- CVP < 2 cm. Hypokalemia- serum potassium concentration < 3.5 mmol/L. Alkalosis- serum bicarbonate > 32 mmol/L. Hyperglycemia- serum glucose > 240 mg/dL. Hypophosphatemia- serum phosphate concentration < 0.8 mmol/L. Hypocalcemia- serum ionized calcium < 2.2 mmol/L. Lactic acidosis- serum lactate > 6 mmol/L.

Outcome measures

Measure	Control Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. 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.	Low Volume Hemofiltration n=2 Participants Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. 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.	High Volume Hemofiltration High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . 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.
Expected Adverse Event	—	2 participants	—

SECONDARY outcome

Timeframe: 48 hours

ST-Elevation Myocardial Infarction- ECG criteria and biomarker criteria for acute infarction.

Radiographic Pulmonary Edema- radiographic presence of alveolar or interstitial edema, bilateral pleural effusions, cardiomegaly or venous congestion.

Arrhythmia- other than sinus rhythm observed after randomization. Arrhythmia requiring treatment- rhythm with subsequent use of an antiarrhythmic drug or electrical therapy observed after randomization.

Arrhythmia with cardiovascular instability- any rhythm with cardiovascular instability as determined by the DSMB, observed after randomization.

Outcome measures

Measure	Control Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. 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.	Low Volume Hemofiltration n=2 Participants Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. 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.	High Volume Hemofiltration High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . 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.
Safety Outcome, Number of Participants With STEMI, Radiographic Pulmonary Edema, or Arrhythmia	—	2 Participant	—

SECONDARY outcome

Timeframe: 48 hours

These will be defined as any unexpected adverse effect on health or safety or any unexpected life-threatening problem caused by, or associated with, a device, if that effect or problem was not previously identified in nature, severity, or degree of incidence in this investigation plan or application which will be submitted to the Food and Drug Administration (including a supplementary plan or application), or any other unexpected serious problem associated with a device. The death or neurological impairment of an individual patient will not be considered an adverse event in this study.

Outcome measures

Measure	Control Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. 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.	Low Volume Hemofiltration n=2 Participants Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. 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.	High Volume Hemofiltration High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . 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.
Unexpected Adverse Device Events (UADE)	—	0 participants	—

SECONDARY outcome

Timeframe: Discharge

Clinical diagnoses of cerebral bleeding, stroke, bleeding requiring transfusion or surgical intervention, rearrest, pulmonary edema, rib or sternal fractures, internal thoracic or abdominal injuries as noted in the discharge summary

Outcome measures

Measure	Control Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. 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.	Low Volume Hemofiltration n=2 Participants Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. 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.	High Volume Hemofiltration High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . 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.
Clinical Safety Outcomes; Number of Participants With Clinical Diagnoses	—	2 participants	—

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Volume Hemofiltration

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

High Volume Hemofiltration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. 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.	Low Volume Hemofiltration n=2 participants at risk Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. 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.	High Volume Hemofiltration High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . 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.
Cardiac disorders Arrhythmia associated with cardiovascular instability	— 0/0	50.0% 1/2	— 0/0

Other adverse events

Measure	Control Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics. 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.	Low Volume Hemofiltration n=2 participants at risk Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Low Volume Hemofiltration: Patients will receive isovolemic HF. 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.	High Volume Hemofiltration High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. . 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.
Cardiac disorders Arrhythmia associated with low blood pressure	— 0/0	50.0% 1/2	— 0/0

Additional Information

Dr. Graham Nichol

University of Washington Harborview Center for Pre Hospital Emergency Care

Phone: 206-521-1728

Email: nichol@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place