- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02894996
Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? (PEDIFLUID)
Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Elective Pediatric Anesthetized Patient?
연구 개요
상세 설명
The main objective is to determine whether the new test "the stroke volume variation after fluid challenge of 3ml/Kg" provides information about fluid responsiveness namely increased cardiac output. This new test will be compared to "gold standard" that is, "the stroke volume variation after standard fluid challenge of 15ml/Kg". It is the evaluation of the diagnostic accuracy of a diagnostic test based on an index obtained by transthoracic cardiac echocardiography for diagnosing fluid responsiveness. This index is the stroke volume variation measured by transthoracic cardiac echography.
The study will include anesthetized patients undergoing scheduled surgery. For hemodynamic optimization, these patients will benefit, early after anaesthetic induction, before the surgical procedure has started, from a fluid challenge of 15ml/kg achieved in two stages (3 ml/Kg then 12 ml/kg) separated by an interval of one minute. Three-time hemodynamic will be analyzed.
- T0: basal
- T1: one minute after first vascular filling with 3ml/Kg in 2 minutes
- T2: one minute after second vascular filling with 12 ml/Kg in 8 minutes which is performed one minute after the end of the first filling (a total of 15 ml/kg)
At each time, we will retrieve a collection of hemodynamic data (stroke volume, cardiac output) obtained by transthoracic echocardiography, standard method to assess fluid responsiveness. And at the same times, the PVI and hemodynamic parameters obtained by esophageal Doppler will be noted.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Rhone Alpes
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Bron, Rhone Alpes, 프랑스, 69500
- Hôpital Femme Mère Enfant
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- pediatric patient for scheduled surgery
- from 8 to 30 kg of weight
Exclusion Criteria:
- denied from the child or their parents
- congenital cardiopathy
- cardiovascular shunt
- respiratory dysfunction
- hepatic dysfunction
- renal dysfunction
- intracranial hypertension
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: Pediatric patient for general anesthesia
Pediatric patients for general anesthesia elected for scheduled surgery Patients weight between 8 and 30 kilograms
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fluid challenge realized after induction of anesthesia at a steady state, to assess fluid responsiveness and correct hypovolemia.
The usual fluid bolus of 15ml/kg in 10 minute will be fragmented in 2 fluid boluses (3ml/kg in 2 minutes followed by measurement of hemodynamic parameter after 1 minute of the end of the 1st fluid bolus and followed by 12 ml/kg in 8 minutes then followed by measurement of hemodynamic parameters after one minute after the end of the 2nd fluid fragmented fluid challenge.
Total administered: 15 ml/kg in 11 minutes.
end of the study at 12 minutes.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Stroke volume variation
기간: 12 minutes
|
The main objective is to determine whether the new test "the stroke volume variation after fluid challenge of 3mL/Kg" provides information about fluid responsiveness namely increased cardiac output.
This new test will be compared to "gold standard" that is, "the stroke volume variation after standard fluid challenge of 15mL/Kg".
It is evaluation of the diagnostic accuracy of a diagnostic test based on an index obtained by transthoracic echocardiography for diagnosing fluid responsiveness.
This index is the stroke volume variation.
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12 minutes
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Correlations between stroke volume variation after expansion of 3mL/Kg and after 15mL/Kg
기간: 12 minutes
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To compare the correlations between stroke volume variation after volume expansion of 3 mL/kg and after volume expansion of 15 mL/kg
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12 minutes
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Diagnostic capacity of PVI and esophageal doppler
기간: 12 minutes
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To assess the capacity of the PVI and of common parameters obtained by esophageal Doppler in diagnosing fluid responsiveness
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12 minutes
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공동 작업자 및 조사자
수사관
- 수석 연구원: Marc Lilot, MD, Hospices Civils de Lyon Direction de la Recherche Clinique et de l'Innovation
간행물 및 유용한 링크
일반 간행물
- Pereira de Souza Neto E, Grousson S, Duflo F, Ducreux C, Joly H, Convert J, Mottolese C, Dailler F, Cannesson M. Predicting fluid responsiveness in mechanically ventilated children under general anaesthesia using dynamic parameters and transthoracic echocardiography. Br J Anaesth. 2011 Jun;106(6):856-64. doi: 10.1093/bja/aer090. Epub 2011 Apr 26.
- Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F; Danish Study Group on Perioperative Fluid Therapy. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003 Nov;238(5):641-8. doi: 10.1097/01.sla.0000094387.50865.23.
- Durand P, Chevret L, Essouri S, Haas V, Devictor D. Respiratory variations in aortic blood flow predict fluid responsiveness in ventilated children. Intensive Care Med. 2008 May;34(5):888-94. doi: 10.1007/s00134-008-1021-z. Epub 2008 Feb 8.
- Gan H, Cannesson M, Chandler JR, Ansermino JM. Predicting fluid responsiveness in children: a systematic review. Anesth Analg. 2013 Dec;117(6):1380-92. doi: 10.1213/ANE.0b013e3182a9557e.
- Aya HD, Ster IC, Fletcher N, Grounds RM, Rhodes A, Cecconi M. Pharmacodynamic Analysis of a Fluid Challenge. Crit Care Med. 2016 May;44(5):880-91. doi: 10.1097/CCM.0000000000001517.
- Desgranges FP, Desebbe O, Pereira de Souza Neto E, Raphael D, Chassard D. Respiratory variation in aortic blood flow peak velocity to predict fluid responsiveness in mechanically ventilated children: a systematic review and meta-analysis. Paediatr Anaesth. 2016 Jan;26(1):37-47. doi: 10.1111/pan.12803. Epub 2015 Nov 6.
- Tibby SM, Hatherill M, Durward A, Murdoch IA. Are transoesophageal Doppler parameters a reliable guide to paediatric haemodynamic status and fluid management? Intensive Care Med. 2001 Jan;27(1):201-5. doi: 10.1007/s001340000795.
- Weber T, Wagner T, Neumann K, Deusch E. Low predictability of three different noninvasive methods to determine fluid responsiveness in critically ill children. Pediatr Crit Care Med. 2015 Mar;16(3):e89-94. doi: 10.1097/PCC.0000000000000364.
- Tibby SM, Hatherill M, Murdoch IA. Use of transesophageal Doppler ultrasonography in ventilated pediatric patients: derivation of cardiac output. Crit Care Med. 2000 Jun;28(6):2045-50. doi: 10.1097/00003246-200006000-00061.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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