Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit for Suspected for Brain Injury (Coolheart)
21 marzo 2015 aggiornato da: Dr. Omer Bar-Yosef, Sheba Medical Center
Efficacy of Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit in Children Suspected for Brain Injury
Cardiac pathology is a major risk for brain injury and neurodevelopmental deficit.
The most common cause of cardiac pathology is congenital heart defects (CHD) about 4-8/1000 live births a year.
The most common etiology of the brain insult is hypoxic ischemic injury (HII) as result of hemodynamic instability in the perioperative period.
Similar insults in adults with cardiac arrest or infants with neonatal asphyxia, was successfully treated with hypothermia, initiated within 6 hours after the event.
Although, hypothermia is most likely an effective treatment for HII in children with cardiac anomaly, it also carries a risk for bleeding or infection of the surgical wound.
In this randomized control trial, hypothermia treatment will be compared to normothermia treatment of patients in the pediatric cardiac intensive care unit (PCICU) following severe HII in the PCICU or operating room.
The effect will be quantified by MRI, serum biomarkers of brain injury, amplitude integrated EEG, neurological evaluation coagulation and infection evaluation in the acute phase and by developmental assessment at 1, 6 months and 2, 5 years.
Favorable effect of hypothermia with minimal risks may open the door for the implementation of hypothermia as a standard care in PCICUs.
Panoramica dello studio
Stato
Sconosciuto
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Anticipato)
75
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 1 giorno a 7 anni (Bambino)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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.
Altri nomi:
|
|
Comparatore placebo: 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.
Altri nomi:
|
|
Nessun intervento: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Biomarkers
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Short term neuro-developmental outcome
Lasso di tempo: 2 months
|
Neurological assessment using standard neurological evaluation, pediatric stroke outcome measure and pediatric cerebral performance category
|
2 months
|
|
Short term neuro-developmental outcome
Lasso di tempo: 5 yrs
|
At 2 and 5 yrs after the hypothermia treatment a c.
Vineland adaptive behavior scale (Vineland™-II) will be done
|
5 yrs
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Omer B Bar Yosef, MD-PhD, Chain Sheba Medical Ceneter
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2015
Completamento primario (Anticipato)
1 aprile 2017
Completamento dello studio (Anticipato)
1 aprile 2020
Date di iscrizione allo studio
Primo inviato
17 marzo 2015
Primo inviato che soddisfa i criteri di controllo qualità
20 marzo 2015
Primo Inserito (Stima)
23 marzo 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
24 marzo 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 marzo 2015
Ultimo verificato
1 marzo 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattie cardiache
- Malattia cardiovascolare
- Malattie vascolari
- Disturbi cerebrovascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Ferite e lesioni
- Anomalie congenite
- Trauma craniocerebrale
- Trauma, sistema nervoso
- Segni e sintomi, respiratori
- Anomalie cardiovascolari
- Cambiamenti di temperatura corporea
- Ischemia cerebrale
- Ischemia
- Lesioni cerebrali
- Difetti cardiaci, congeniti
- Ipossia
- Ipotermia
Altri numeri di identificazione dello studio
- SMC-0616-13
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .