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Phase 2 N=2 Randomized Single-blind Treatment

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

Cardiac Arrest

Enrolled (actual)
2
Serious AEs
50.0%
Results posted
Jun 2016
Primary outcome: Primary: Intervention Compliance — 1 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Standard Care (Other); Low Volume Hemofiltration (Device); High Volume Hemofiltration (Device)
Age
Older Adult · 65+ yrs
Sex
All
Sponsor
University of Washington
Primary completion
Nov 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Intervention Compliance
1
SECONDARY
Enrollment
2
SECONDARY
Clearance of Inflammatory Mediators
SECONDARY
Total Volume Intravenous Fluid Infused
10652.5
SECONDARY
Use of Pressors and Inotropes
1
SECONDARY
Shock
SECONDARY
Ejection Fraction
65
SECONDARY
Number of Hospital Days
8.5
SECONDARY
Time Interval From 911 Call to Patient Death
183.6
SECONDARY
Expected Adverse Event
2
SECONDARY
Safety Outcome, Number of Participants With STEMI, Radiographic Pulmonary Edema, or Arrhythmia
2
SECONDARY
Unexpected Adverse Device Events (UADE)
SECONDARY
Clinical Safety Outcomes; Number of Participants With Clinical Diagnoses
2

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.

Eligibility Criteria

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 1.5) or inferior vena cava filter in situ
  • known cirrhosis
  • serum ionized calcium 6 mmol/L
  • obeying verbal commands
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01509040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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