- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02395276
Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit for Suspected for Brain Injury (Coolheart)
Efficacy of Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit in Children Suspected for Brain Injury
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Every child entering the PCICU, age < 7 years
- The child will enter arm 1 or 2 if he underwent the event described in section 3.
Hypoxic ischemic event that would render hypothermia treatment is defined as
- During the hospitalization in the PCICU before or after the surgery:
Resuscitation comprised of chest compressions for more than 2 minutes, and the first blood tests immediately after the resuscitation show a serum lactate level of more than 90 mg/dl OR Resuscitation comprised of chest compressions for more than 2 minutes, and the first blood tests immediately after the resuscitation shows a serum lactate level of more than 40 mg/dl and a blood pH level of less than 7.1
- During the surgery Near infra red spectroscopy lower than 40 for more than 5 minutes AND Serum lactate levels of more than 90 mg/dl during the event OR The patient is re-connected to cardio-pulmonary bypass machine as a result of the event
- Initiation of hypothermia treatment within 6 hours following the hypoxic ischemic event defined in section 3.
Exclusion criteria
- Suspected hypoxic ischemic event as described in the Inclusion Criteria in the 2 weeks prior to the PCICU admission
- Prolonged low cerebral perfusion before the PCICU admission, with 3 repeated tests in 1 hour of lactate level higher than 40 mg/dl and pH lower than 7.1
- Rejection criteria
- A second resuscitation after the hypoxic ischemic event and before a brain MRI is done
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Whole body hypothermia
Children that had an event suspected for hypoxic ischemic brain injury, according to the inclusion criteria, will be randomly allocated for whole body hypothermia therapy.
Treatment will be initiated within 6 hours of the event, the child will be dressed with a cooling suit and their temperature will be monitored.
Whole body hypothermia will be to 33 +/- 1 °C .
Treatment period will be 48 hours with 24 hours warming up period.
|
Treatment will be initiated within 6 hours of the event, the child will be dressed with a cooling suit and their temperature will be monitored.
Cooling will be to 33 +/- 1 °C .
Treatment period will be 48 hours with 24 hours warming up period.
Andre navn:
|
Placebo komparator: Whole body normothermia
Children that had an event suspected for hypoxic ischemic brain injury, according to the inclusion criteria, will be randomly allocated for normothermia therapy.
Treatment will be initiated within 6 hours of the event, the child will be dressed with a cooling suit and their temperature will be monitored.
Cooling will be to 36-37 °C .
Treatment period will be 72 hrs.
|
Treatment will be initiated within 6 hours of the event, the child will be dressed with a cooling suit and their temperature will be monitored.
Cooling will be to 33 +/- 1 °C .
Treatment period will be 48 hours with 24 hours warming up period.
Andre navn:
|
Ingen inngripen: Control
A group of children that underwent a cardiac surgery and was not suspected to have an hypoxic ischemic brain injury.
This group will be undergo the similar biomarkers collection as arm 1 and 2. The information will be used to measure the change in biomarkers between surgeries with no HII to those in arm 1+2.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Biomarkers
Tidsramme: 48 hours after the surgery
|
Each child will have 4 blood samples for biomarkers including S100B, Glial Fibrillary Acidic Protein and Specific Neuronal Enolase at the following schedule: before the cardiac surgery, within 6 hr after the surgery, 24 and 48 hrs after the surgery
|
48 hours after the surgery
|
Magnetic Resonance Imaging
Tidsramme: 10 days after
|
In arms 1 and 2 an MRI with the sequences of T1, T2, Diffusion Weighted Imaging, Diffuse Tensor Imaging and Magnetic Resonance Spectroscopy
|
10 days after
|
Neurological Evaluation
Tidsramme: 1 week
|
Neurological assessment will be done prior to the cardiac surgery and and one week (or earlier if the child will be fully recovered and discharged before) using standard neurological evaluation, pediatric stroke outcome measure
|
1 week
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Short term neuro-developmental outcome
Tidsramme: 2 months
|
Neurological assessment using standard neurological evaluation, pediatric stroke outcome measure and pediatric cerebral performance category
|
2 months
|
Short term neuro-developmental outcome
Tidsramme: 5 yrs
|
At 2 and 5 yrs after the hypothermia treatment a c.
Vineland adaptive behavior scale (Vineland™-II) will be done
|
5 yrs
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Omer B Bar Yosef, MD-PhD, Chain Sheba Medical Ceneter
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Hjertesykdommer
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Sår og skader
- Medfødte abnormiteter
- Kraniocerebralt traume
- Traumer, nervesystemet
- Tegn og symptomer, luftveier
- Kardiovaskulære abnormiteter
- Endringer i kroppstemperaturen
- Hjerneiskemi
- Iskemi
- Hjerneskader
- Hjertefeil, medfødt
- Hypoksi
- Hypotermi
Andre studie-ID-numre
- SMC-0616-13
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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