Washington Study of Hemofiltration After Out-of-Hospital Cardiac Arrest
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 6/10/2016 |
| Start Date: | January 2012 |
| End Date: | June 2014 |
The purpose of this study is to assess the feasibility of hemofiltration in patients
resuscitated from cardiac arrest. Cardiac arrest is the loss of mechanical activity of the
heart including the loss of detectable pulse, or spontaneous breathing. When heart function
is restored, the cells of the body release molecules into the blood that cause inflammation,
unstable blood pressure, organ dysfunction and death. Hemofiltration is a technique of
washing the blood to remove fluid and molecules from it. Hemofiltration is a proven therapy
for renal failure, but is considered investigational for treatment after resuscitation from
cardiac arrest. Some experts believe that hemofiltration after heart function is restored
can remove inflammation from the blood, maintain blood pressure and organ function. Others
believe that intravenous fluid and medications are sufficient to maintain blood pressure and
organ function. Since the inflammation that occurs after restoration of heart function
lasts, the investigators continue hemofiltration for up to 48 hours. Whether hemofiltration
or intravenous fluids and medications is better is not known. The investigators are checking
if they can wash the blood of patients resuscitated from cardiac arrest before the
investigators can begin a large randomized trial to test whether hemofiltration improves
their outcome.
The investigators are testing this by randomly allocating patients resuscitated from cardiac
arrest to receive low volume hemofiltration, high volume hemofiltration, or intravenous
fluids and medications alone. The null hypotheses are that less than 80% of eligible
patients will be enrolled, and that less than 80% of enrolled patients will undergo
low-volume or high-volume hemofiltration (HF) for at least 80% of 48 hours.
resuscitated from cardiac arrest. Cardiac arrest is the loss of mechanical activity of the
heart including the loss of detectable pulse, or spontaneous breathing. When heart function
is restored, the cells of the body release molecules into the blood that cause inflammation,
unstable blood pressure, organ dysfunction and death. Hemofiltration is a technique of
washing the blood to remove fluid and molecules from it. Hemofiltration is a proven therapy
for renal failure, but is considered investigational for treatment after resuscitation from
cardiac arrest. Some experts believe that hemofiltration after heart function is restored
can remove inflammation from the blood, maintain blood pressure and organ function. Others
believe that intravenous fluid and medications are sufficient to maintain blood pressure and
organ function. Since the inflammation that occurs after restoration of heart function
lasts, the investigators continue hemofiltration for up to 48 hours. Whether hemofiltration
or intravenous fluids and medications is better is not known. The investigators are checking
if they can wash the blood of patients resuscitated from cardiac arrest before the
investigators can begin a large randomized trial to test whether hemofiltration improves
their outcome.
The investigators are testing this by randomly allocating patients resuscitated from cardiac
arrest to receive low volume hemofiltration, high volume hemofiltration, or intravenous
fluids and medications alone. The null hypotheses are that less than 80% of eligible
patients will be enrolled, and that less than 80% of enrolled patients will undergo
low-volume or high-volume hemofiltration (HF) for at least 80% of 48 hours.
Patients resuscitated from out-of-hospital cardiac arrest will be randomly allocated to one
of three groups; Standard of care: Initiate standard of post-resuscitative care including a
triple lumen catheter to monitor central venous pressure, core temperature maintenance
between 32C and 34C if unconscious. Fluids, inotropes, vasopressors, vasodilators to
maintain hemodynamics.
Low-volume Hemofiltration for 48 hours: Initiate standard of post-resuscitative care
including a triple lumen catheter to monitor central venous pressure, core temperature
maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via a 11.5F double
lumen venous catheter, blood flow 250mL/h, ultrafiltration 45mL/kg/h. Fluids, inotropes,
vasopressors, vasodilators to maintain hemodynamics.
High-volume Hemofiltration for 48 hours: Initiate standard of post-resuscitative care
including a triple lumen catheter to monitor central venous pressure, core temperature
maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via 11.5F double
lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h. Fluids, inotropes,
vasopressors, vasodilators to maintain hemodynamics.
30 patients will be enrolled.
of three groups; Standard of care: Initiate standard of post-resuscitative care including a
triple lumen catheter to monitor central venous pressure, core temperature maintenance
between 32C and 34C if unconscious. Fluids, inotropes, vasopressors, vasodilators to
maintain hemodynamics.
Low-volume Hemofiltration for 48 hours: Initiate standard of post-resuscitative care
including a triple lumen catheter to monitor central venous pressure, core temperature
maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via a 11.5F double
lumen venous catheter, blood flow 250mL/h, ultrafiltration 45mL/kg/h. Fluids, inotropes,
vasopressors, vasodilators to maintain hemodynamics.
High-volume Hemofiltration for 48 hours: Initiate standard of post-resuscitative care
including a triple lumen catheter to monitor central venous pressure, core temperature
maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via 11.5F double
lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h. Fluids, inotropes,
vasopressors, vasodilators to maintain hemodynamics.
30 patients will be enrolled.
Inclusion Criteria:
- adults
- restoration of spontaneous circulation sustained to hospital arrival after OOHCA with
any first recorded rhythm
- aged >=65 years
- less than 1 h from call to 911 until emergency department arrival
- less than 6 h from arrival until randomization
- informed consent provided by legally-authorized representative
Exclusion Criteria:
- do not attempt resuscitation orders; known end-stage terminal illness pre-arrest;
major pre-arrest neurological dysfunction; another reason to be comatose (e.g. drug
overdose)
- chronic steroid use
- non-English speaking LAR
- previous enrollment in the trial
- blunt, penetrating, or burn-related injury; exsanguination; drowning, electrocution
or strangulation
- known pregnancy
- known prisoner
- weight > 100 kg
- persistent (i.e. 30 minutes) SBP< 80 mmHg despite pressors; refractory ventricular
arrhythmias; severe bradycardia without a pacemaker
- thrombocytopenia (i.e. < 50,000/microL) or coagulopathy (i.e. INR > 1.5) or inferior
vena cava filter in situ
- known cirrhosis
- serum ionized calcium < 2.2 mmol/L serum lactate > 6 mmol/L
- obeying verbal commands
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