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The use of helium after cardiac arrest.


- candidate number7870
- NTR NumberNTR2257
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-mrt-2010
- Secondary IDsMEC 09/333 / NL 30466.018.09 ; METC AMC / CCMO
- Public TitleThe use of helium after cardiac arrest.
- Scientific TitleThe use of helium after resuscitation: a safety and feasibility study.
- ACRONYMHERES study
- hypothesisHelium can be safely used in patients admitted to the ICU after resuscitation for out-of-hospital cardiac arrest.
- Healt Condition(s) or Problem(s) studiedHelium, Cardiac arrest, Postanoxic coma, Resuscitation
- Inclusion criteria1. Admission to the ICU with postanoxic coma after OHCA;
2. First registered rhythm VF/VT;
3. Witnessed arrest;
4. Return of spontaneous circulation within 30 minutes;
5. Induced mild hypothermia;
6. Ability to start study medication within 6 hours.
- Exclusion criteria1. Life expectancy < 6 months prior to arrest;
2. Neurological disosrder prior to arrest;
3. Severly disabled prior to arrest;
4. Pregnancy;
5. Pulmonary illness, requiring ventilation with >50% FiO2 and > 10 cmH2O PEEP.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 6-apr-2010
- planned closingdate31-dec-2011
- Target number of participants25
- InterventionsVentilation with helium/oxygen (50%/50%) during the first 3 hours after inclusion.
- Primary outcomeOccurence of major adverse events (death, inability to effectivly ventilate using helium/oxygen).
- Secondary outcome1. Arterial blood gas;
2. Ventilator settings;
3. Creatine Kinase;
4. Creatine Kinase MB;
5. Troponin-T;
6. Neuro Specific Enolase;
7. Glassgow Outcome Score;
8. Mortality;
9. Duration of mechanical ventilation;
10. Length of stay on ICU.
- Timepoints1. ABG at 0, 1, 2, 3, 4, 5 and 6 hours;
2. Ventilator settings at 0, 1, 2, 3, 4, 5 and 6 hours;
3. CK at 0, 6, 12, 18, 24 and 48 hours;
4. CK-MB at 0, 6, 12, 18, 24 and 48 hours;
5. Troponin-T at 0, 6, 12, 18, 24 and 48 hours;
6. NSE at 24 and 48 hours;
7. Glassgow Outcome Score at 30 days;
8. Mortality at 30 days.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. Daniel Brevoord
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Janneke Horn
- Sponsor/Initiator University of Amsterdam (UvA), Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD24-mrt-2010 - 15-apr-2016


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