Immuno Nutrition by L-citrulline for Critically Ill Patients (Immunocitre)
연구 개요
상세 설명
This is a multicentric therapeutic trial, randomized and double blind: standard enteral nutrition plus L-citrulline (5 grams/12 Hours for 5 days from the admission in Intensive Care Unit (ICU)) versus standard enteral nutrition plus placebo.
Methods-Patients: Non-surgical patients admitted in medical intensive care unit, under mechanical ventilation for an expected duration > 2 days, without severe sepsis or septic shock, will be enrolled. Symptoms leading for ICU admission ongoing for five days maximum. On admission (before treatment), the severity will be evaluated with the Sepsis-related Organ Failure Assessment (SOFA) score together with an assessment of plasmatic arginine, cytokines (InterLeukin-6 (IL6) ), and expression of Human Leukocyte Antigen - antigen D Related (HLA-DR) by monocytes. The same evaluation will be repeated on day 3 (during treatment) and on day 7 (after treatment).
The enrolment of 100 patients is statistically enough to demonstrate a decreased SOFA scores in the L-citrulline group as compared to the placebo group on day 7.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Angers, 프랑스
- CHU Angers
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Nantes, 프랑스
- CHU Nantes
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Paris, 프랑스
- Paris - HEGP
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Rennes, 프랑스, 35033
- Rennes Hospital University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- age > 18 years
- medical patient (absence of recent surgery or trauma)
- initial aggression < 5 days
- mechanically ventilated with expected duration of mechanical ventilation > 2 days
- exclusive enteral nutrition
- absence of previous immunosuppression
Exclusion Criteria:
- severe sepsis
- septic shock
- obesity defined as BMI above 40
- pregnancy
공부 계획
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디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: L-Citrulline group
Enteral nutrition 5-day L-citrulline treatment (10 grams/day)
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위약 비교기: Control group
Enteral nutrition 5-day placebo treatment
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Organ failure score comparison D7
기간: At day 7
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Organ failure score (SOFA score) on day 7 in the L-citrulline group as compared to the placebo group
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At day 7
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Organ failure score comparison D3
기간: At day 3
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Organ failure score (SOFA score) on day 3 in the L-citrulline group as compared to the placebo group
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At day 3
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SOFA score evolution between randomisation and D7
기간: up to 7 days
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Binary criterion of success or failure : - Success is defined by: an improved SOFA score of at least 2 points from randomization to Day 7 or an improvement in the general condition yielding the release of the unit; - Failure is defined by an improved SOFA score but less than 2 points, no improvement or worsening of the SOFA score from randomization to Day 7 or the patient's death before J7; |
up to 7 days
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Expression of HLA-DR
기간: At day 7
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Expression of HLA-DR in the L-citrulline group as compared to the placebo group
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At day 7
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Plasmatic concentration of IL6
기간: At day 7
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Comparison of the plasmatic concentration of interleukin-6 between the L-citrulline group and the placebo group
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At day 7
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HLA-DR
기간: At day 7
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Comparison of the percentage of expression of monocytic HLA-DR between the L-citrulline group and the placebo group
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At day 7
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Plasmatic concentration of L-arginine
기간: At day 7
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Comparison of the plasmatic concentration of L-arginine and its metabolites between the L-citrulline group and the placebo group
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At day 7
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Incidence of nosocomial infections
기간: during the stay in the ICU, an average of 7 days
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Comparison between the L-citrulline group and the placebo group
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during the stay in the ICU, an average of 7 days
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Length of stay
기간: during the stay in hospital, up to 28 days
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Length of stay in ICU and hospital: Comparison between the L-citrulline group and the placebo group
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during the stay in hospital, up to 28 days
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Mortality
기간: during the stay in hospital, up to 28 days
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during the stay in hospital, up to 28 days
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Duration of mechanical ventilation
기간: during the stay in ICU, an average of 7 days
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Duration of mechanical ventilation: Comparison between the L-citrulline group and the placebo group
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during the stay in ICU, an average of 7 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jean-Marc TADIE, MD, CHU Rennes
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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