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

Cardiac Arrest Clinical Trial

Official title: Washington Study of Hemofiltration After Out-of-Hospital Cardiac Arrest

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

• NCT number: NCT01509040
• Study type: Interventional
• Source: University of Washington
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2012
• Completion date: June 2014