소아 중환자실에서 일차 진정제로 DEXmedetomidine 사용이 섬망에 미치는 영향 (PEDIADEX)
소아 중환자실에서 일차 진정제로 덱스메데토미딘 사용이 섬망에 미치는 영향: PEDIADEX 무작위 대조 시험
The goal of this clinical trial is to learn if dexmedetomidine can reduce delirium in critically ill children, needing mechanical ventilation for more than 12 hours. The main question it aims to answer is :
• Does dexmedetomidine reduce the proportion of children presenting at least one episode of delirium during their intensive care unit (ICU) stay ? Researchers will compare dexmetomidine to midazolam, to see if the use of dexmedetomidine reduces the prevalence of delirium.
Participants will be sedated with midazolam or dexmedetomidine, according to randomization arm, and the rest of sedation is determined by the study protocol.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
- In the experimental group, participants will receive dexmedetomidine as primary sedative, with opioids for analgesia in order to reach sedation within the target range evaluated with the COMFORT B scale every 4 hours.
The initial dose of dexmedetomidine continuous infusion is 0.7 µg/kg/h with increases of 0.2 µg/kg/h if needed associated to an opioid continuous infusion (sufentanil at 0.2 µg/kg/h or morphine at 40 µg/kg/h). A protocol to adjust level of sedation according to the COMFORT B scale will be followed with maximal doses of 1.4 µg/kg/h for dexmedetomidine, 1.5 µg/kg/h for sufentanil and 300 µg/kg/h for morphine. Other drugs like ketamine up to 2 mg/kg/h, propofol, other opioids, midazolam at bolus or small doses (beginning between 20 µg/kg/h and 0.5 mg/h according to age/weight) are possible and will be reported.
- In the control group, participants with invasive ventilation will receive midazolam as first line therapy with opioids in order to reach sedation within the target sedation range evaluated with the COMFORT B scale every 4 hours.
The initial dose of midazolam is 40 µg/kg/h for children <2 years, 60 µg/kg/h for children after 2 years, and 1 mg/h for children >40kg associated with sufentanil at 0.2 µg/kg/h or intravenous morphine at 40 µg/kg/h. A protocol to adjust level of sedation according to the COMFORT B scale will be followed with maximal doses of 200 µg/kg/h and 10 mg/h if >40kg for midazolam and 1.5 µg/kg/h for sufentanil or 300 mcg/kg/h for morphine. Other drugs like ketamine up to 2 mg/kg/h, propofol, other opioids, are possible and noted. In case of failure, addition of dexmedetomidine will be possible only if midazolam is used at maximal doses.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 3단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Julie Chantreuil, Dr
- 전화번호: +33247478214
- 이메일: j.chantreuil@chu-tours.fr
연구 연락처 백업
- 이름: Lea Savary, Dr
- 전화번호: +33147474756
- 이메일: l.savary@chu-tours.fr
연구 장소
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Angers, 프랑스, 49933
- CHU d'Angers
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연락하다:
- Amandine Prenant, Dr
- 전화번호: +33241355088
- 이메일: amandine.prenant@chu-angers.fr
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Caen, 프랑스, 14033
- CHU de Caen
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연락하다:
- David Brossier, Dr
- 전화번호: +33231063106
- 이메일: brossier-d@chu-caen.fr
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Lille, 프랑스, 59120
- CHU de Lille
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연락하다:
- Stephane Leteurtre, Pr
- 전화번호: +33320445982
- 이메일: stephane.LETEURTRE@chu-lille.fr
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Marseille, 프랑스, 13385
- CHU de Marseille
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연락하다:
- Fabrice Michel, Pr
- 전화번호: +33413429525
- 이메일: fabrice.michel@ap-hm.fr
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Nantes, 프랑스, 44093
- CHU de Nantes
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연락하다:
- Bénédicte Gaillard-Leroux, Dr
- 전화번호: +33240083483
- 이메일: benedicte.gaillardleroux@chu-nantes.fr
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Strasbourg, 프랑스, 67200
- CHU de Strasbourg
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연락하다:
- Charlie Demelo, Dr
- 전화번호: +33388127317
- 이메일: charlie.demelo@chru-strasbourg.fr
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Tours, 프랑스, 37000
- CHU de Tours
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연락하다:
- Julie Chantreuil, Dr
- 전화번호: +33247478214
- 이메일: j.chantreuil@chu-tours.fr
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Children between 1month to 17 years and 6 months
- Sedation and analgesia for mechanical ventilation for more than 12 hours
- Participants covered by or entitled to French social security
- Informed consent, dated and signed, from the participant's legal representative(s). (The emergency inclusion procedure will be used if the legal representative(s) cannot be contacted. When the legal representative(s) and the patient are available and/or able to consent, informed consent from the participant's legal representative(s)
- Ability for participant to comply with the requirements of the study
- Receiving sedation by benzodiazepines for less than 6 hours at the time of inclusion
Exclusion Criteria:
- Patients under guardianship, curatorship or legal protection
- Pregnant or breastfeeding woman (positive pregnancy test for women of childbearing age)
- High-grade heart conduction disorder (Second or third-degree atrioventricular block)
- Status epilepticus
- Intracranial hypertension
- Sedation for more than 6 hours by benzodiazepines at the time of inclusion
- Need for paralytic medication (neuromuscular blocker) at admission to PICU
- Following cardiac surgery
- Palliative care on admission
- Significant bradycardia
- Severe hepatic dysfunction (CHILD score C or worse) due to the hepatic metabolism of dexmedetomidine
- Patient already enrolled in the study previously
- Expected duration of invasive mechanical ventilation inferior to 12 hours
- Hospitalized in a pediatric intensive care unit without computerized prescription software
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: dexmedetomidine
Participants with invasive ventilation will receive dexmedetomidine as primary sedative, with opioids for analgesia in order to reach sedation within the target range evaluated with the COMFORT B scale every 4 hours. |
Participants in intervention arm will receive dexmedetomidine as primary sedative. We will assess if there is less delirium in the intervention arm |
|
활성 비교기: midazolam
In the control group, participants will receive midazolam as first line therapy with opioids in order to reach sedation within the target sedation range evaluated with the COMFORT B scale every 4 hours |
participant will receive midazolam as the comparator group |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of children with at least one episode of delirium during the ICU stay.
기간: From enrollment to the end of ICU stay, up to 90 days
|
Surveillance of delirium is part of the routine neurological monitoring in pediatric ICU. CAPD score is an 8-items scale. A score of 9 points or higher indicates the presence of delirium. We will evaluate the proportion of children with at least one CAPD score higher than 9. |
From enrollment to the end of ICU stay, up to 90 days
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Sedation efficacy
기간: From enrollment to the end of sedation, up to 90 days
|
Investigators will assess:
|
From enrollment to the end of sedation, up to 90 days
|
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Duration of delirium
기간: from enrollment to the end of ICU stay, up to 90 days
|
Investigators will assess the number of days with CAPD score higher than or equal to 9 |
from enrollment to the end of ICU stay, up to 90 days
|
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Adverse events and serious adverse events
기간: From enrollment to the end of ICU stay, up to 90 days
|
Investigators will record:
|
From enrollment to the end of ICU stay, up to 90 days
|
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Mechanical ventilation
기간: From enrollment to extubation, for an average of 7 days
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Investigators will report the mechanical ventilation time in hours |
From enrollment to extubation, for an average of 7 days
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Health economic end points
기간: From enrollment to the end of hospital stay, up to 90 days
|
Investigators will assess the cumulative doses of IV sedative and analgesic drugs so we can compare:
|
From enrollment to the end of hospital stay, up to 90 days
|
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Severity of delirium
기간: from enrollement to the end of hospital stay, up to 90 days
|
Investigators will assess the severity of delirium defined by the need for antipsychotic drugs |
from enrollement to the end of hospital stay, up to 90 days
|
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Need for re-intubation
기간: from enrollment, to the end of hospital stay, up to 90 days
|
Investigators will report the need for re-intubation post extubation |
from enrollment, to the end of hospital stay, up to 90 days
|
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Need for neurological investigations
기간: from enrollement to the end of hospital stay, up to 90 days
|
Investigators will report the percentage of brain imaging and electroencephalogramm |
from enrollement to the end of hospital stay, up to 90 days
|
|
Length of stay
기간: from enrollement to the end of hospital stay, up to 90 days
|
Investigators will report
|
from enrollement to the end of hospital stay, up to 90 days
|
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Mortality
기간: from enrollement, to the end of follow-up, up to 90 days
|
Investigators will assess: hospital mortality |
from enrollement, to the end of follow-up, up to 90 days
|
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Withdrawal
기간: from enrollement to the end of ICU stay, up to 90 days
|
Investigators will assess the incidence of iatrogenic withdrawal syndrome, measured with WAT-score (defined by WAT > 4) |
from enrollement to the end of ICU stay, up to 90 days
|
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Associated sedation
기간: from enrollement, to the end of sedation, up to 90 days
|
Investigators will assess the daily cumulative weight-adjusted dose of IV sedative agents (benzodiazepine, ketamine, propofol) and opioids required in each group. |
from enrollement, to the end of sedation, up to 90 days
|
|
Duration of sedation
기간: from enrollment, to the end of sedation, up to 90 days
|
Invesitgators will assess the number of days exposed to sedatives and opioids |
from enrollment, to the end of sedation, up to 90 days
|
공동 작업자 및 조사자
협력자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- PEDIADEX
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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