Cardiac ArrestPhase 1/2NCT01509040
Washington Study of Hemofiltration After Out-of-Hospital Cardiac Arrest
A Phase 1/2 study testing Low Volume Hemofiltration and High Volume Hemofiltration in people with Cardiac Arrest, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Low Volume Hemofiltration and High Volume Hemofiltration
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98040
About this study
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.
Read the detailed 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.
- Conditions
- Cardiac Arrest
- Being tested
- Standard Care, Low Volume Hemofiltration, High Volume Hemofiltration
- Keywords
- Resuscitated from Out-of-Hospital Cardiac Arrest
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard CareOther
Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.
Initiation and maintenance of therapeutic hypothermia, target core temperature of below 34°C via standard external cooling techniques.
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 HemofiltrationDevice
Patients will receive isovolemic HF at a blood flow rate of 250 mL/min and ultrafiltration rate of 45 mL/kg/h for 48 hours. 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 HemofiltrationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Initiate standard post-resuscitative care including a triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Fluids, 500-mL bolus of intravenous crystalloid given 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. Receives: Other: Standard Care |
| Low Volume Hemofiltration | Experimental | Initiate standard 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 45 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given 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. Receives: Other: Standard Care; Device: Low Volume Hemofiltration |
| High Volume Hemofiltration | Experimental | Initiate standard 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/kg/h, ultrafiltration 90 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given 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. Receives: Other: Standard Care; Device: High Volume Hemofiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Compliance
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.
Measured: 48 hours
Secondary outcomes (12)
Enrollment
This will be defined as the proportion of eligible patients who are randomized.
Measured: 12 hours
Clearance of Inflammatory Mediators
Venous blood samples will be obtained periodically after randomization, processed, stored, then tested for serum cytokine levels.
Measured: 48 hours
Total Volume Intravenous Fluid Infused
This will be defined as the volume of fluid (in mL) infused during the first 48 hours from enrollment.
Measured: 48 hours
Use of Pressors and Inotropes
This includes use of dopamine, dobutamine, epinephrine, nesiritide, norepinephrine, or phenylephrine during the first 48 hours from enrollment.
Measured: 48 hours
Shock
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.
Measured: 48 hours
Ejection Fraction
This will be assessed by standard transthoracic echocardiographic methods 48 hours after enrollment in control and intervention patients
Measured: 48 hours
Number of Hospital Days
This will be described for all hospitalized patients as a measure of morbidity after resuscitation.
Measured: 6 months
Time Interval From 911 Call to Patient Death
This will be described for all hospitalized patients as a measure of morbidity after resuscitation.
Measured: 1 year
Expected Adverse Event
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.
Measured: 48 hours
Safety Outcome, Number of Participants With STEMI, Radiographic Pulmonary Edema, or Arrhythmia
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.
Measured: 48 hours
Unexpected Adverse Device Events (UADE)
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.
Measured: 48 hours
Clinical Safety Outcomes; Number of Participants With Clinical Diagnoses
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
Measured: Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Graham Nichol, University of Washington
- Investigators
- Graham Nichol, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509040
- Sponsor's protocol ID
- WASH CARDIAC
- Status last verified
- Jun 2016
- First submitted
- 9 Jan 2012
- Last updated
- 9 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Washington Study of Hemofiltration After Out-of-Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT01509040
- Acronym / sponsor ID
- WASH CARDIAC
- Conditions
- Cardiac Arrest
- Keywords
- Resuscitated from Out-of-Hospital Cardiac Arrest
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Posted 9 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Standard CareInitiate standard post-resuscitative care including a triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Fluids, 500-mL bolus of intravenous crystalloid given 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. |
| Low Volume Hemofiltration | Experimental | Other: Standard Care, Device: Low Volume HemofiltrationInitiate standard 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 45 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given 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. |
| High Volume Hemofiltration | Experimental | Other: Standard Care, Device: High Volume HemofiltrationInitiate standard 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/kg/h, ultrafiltration 90 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard CareTriple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above. Initiation and maintenance of therapeutic hypothermia, target core temperature of below 34°C via standard external cooling techniques. 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. | Other | Control, High Volume Hemofiltration, Low Volume Hemofiltration |
| Low Volume HemofiltrationPatients will receive isovolemic HF at a blood flow rate of 250 mL/min and ultrafiltration rate of 45 mL/kg/h for 48 hours. 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. | Device | Low Volume Hemofiltration |
| High Volume HemofiltrationPatients 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. | Device | High Volume Hemofiltration |
Primary outcome
Intervention Compliance
Time frame: 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.
12 secondary outcomes
Enrollment
Time frame: 12 hours
Clearance of Inflammatory Mediators
Time frame: 48 hours
Total Volume Intravenous Fluid Infused
Time frame: 48 hours
Use of Pressors and Inotropes
Time frame: 48 hours
Shock
Time frame: 48 hours
Ejection Fraction
Time frame: 48 hours
Number of Hospital Days
Time frame: 6 months
Time Interval From 911 Call to Patient Death
Time frame: 1 year
Expected Adverse Event
Time frame: 48 hours
Safety Outcome, Number of Participants With STEMI, Radiographic Pulmonary Edema, or Arrhythmia
Time frame: 48 hours
Unexpected Adverse Device Events (UADE)
Time frame: 48 hours
Clinical Safety Outcomes; Number of Participants With Clinical Diagnoses
Time frame: Discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham Nichol, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Low Volume Hemofiltration and High Volume Hemofiltration in people with Cardiac Arrest, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Compliance (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.