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A cluster randomized trial of duration of cooling in therapeutic hypothermia after resuscitation for cardiac arrest

A cluster randomized trial of duration of cooling in therapeutic hypothermia after resuscitation for cardiac arrest - J-PULSE-Hypo-DC trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007615
Enrollment
180
Registered
2012-03-31
Start date
2012-03-31
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Interventions

Targeted cooling duration 12-24 hours in Therapeutic hypothermia Targeted cooling duration 36 hours in Therapeutic hypothermia

Sponsors

J-PULSE-Hypo investigators
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Cardiac arrest 2)Stability of circulatory dynamics after ROSC(Return of spontaneous circulation) [including assisted with drug or auxiliary circulating pump] 3)Comatose state after ROSC 4)Adaptability status of therapeutic Hypothermia

Exclusion criteria

Exclusion criteria: Patients with: Pregnancy Acute aortic dissection Pulmonary thromboembolism Drug poisoning Poor daily activity

Design outcomes

Primary

MeasureTime frame
Incidence proportion of complications within 1 month. Definition of complications; infection, hemorrhage, Arrhythmia, decreasing blood pressure, shivering, convulsion and MACE(Major Adverse Cardiovascular Events) The evaluation of primary outcome is under blinded groups by Data Safety Monitoring Board

Secondary

MeasureTime frame
1) Proportion of death (within 24 hours, 7 days, 1 months, 3 months, at discharge) 2)Proportion of good neurological outcome (CPC: Cerebral Performance Categories) (within 24 hours, 7 days, 1 months, 3 months, at discharge) 3) Mortaliry rate 4) Incidence rate of complications

Countries

Japan

Contacts

Public ContactHiroyuki Yokoyama

National Cerebral and Cardiovascular Center Division of Cardiovascular Care Unit

hiyokoyama@hsp.ncvc.go.jp06-6833-5012(2231)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026