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Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit for Suspected for Brain Injury (Coolheart)

21. marts 2015 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

75

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 dag til 7 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Every child entering the PCICU, age < 7 years
  2. The child will enter arm 1 or 2 if he underwent the event described in section 3.

  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
  4. 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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.
Enhed: Whole body hypothermia
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 navne:
  • ThermoWrap® cover and Alon® Control Unit
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.
Enhed: Whole body hypothermia
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 navne:
  • ThermoWrap® cover and Alon® Control Unit
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sheba Medical Center

Efterforskere

  • Ledende efterforsker: Omer B Bar Yosef, MD-PhD, Chain Sheba Medical Ceneter

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2015

Primær færdiggørelse (Forventet)

1. april 2017

Studieafslutning (Forventet)

1. april 2020

Datoer for studieregistrering

Først indsendt

17. marts 2015

Først indsendt, der opfyldte QC-kriterier

20. marts 2015

Først opslået (Skøn)

23. marts 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SMC-0616-13

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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