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COMPLETED Phase 1

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

NCT01509040 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • OTHER Standard Care
  • DEVICE Low Volume Hemofiltration
  • DEVICE High Volume Hemofiltration

Study Locations (1)

Washington

  • Harborview Medical Center — Seattle

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2012-01
Est. Completion 2014-06
Phase Phase 1

Sponsor

University of Washington

987 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01509040

The ClinicalTrials.gov registry entry for NCT01509040 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 987 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cardiac Arrest appearing as the primary indexed condition, and to 3 interventions — of which Standard Care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01509040 reports 1 study location spanning 1 distinct geographic area — top geographies include Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01509040 about?

NCT01509040 is a clinical study titled "Washington Study of Hemofiltration After Out-of-Hospital Cardiac Arrest". 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 bo...

What is the current status of trial NCT01509040?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2012-01. Estimated completion is 2014-06.

What conditions does trial NCT01509040 study?

This clinical trial studies the following conditions: Cardiac Arrest. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01509040?

The interventions under investigation include: Standard Care (OTHER), Low Volume Hemofiltration (DEVICE), High Volume Hemofiltration (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01509040?

This trial is sponsored by University of Washington, which has 987 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01509040 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial