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ICU에서 침습적 기계 환기 및 승압 치료 후 환자 결과에 대한 개별 맞춤형 영양 및 신체 활동을 결합한 조기 및 확장 재활 프로그램의 영향 (NUTRIREA-4)

2026년 9월 29일 업데이트: Nantes University Hospital

ICU에서 침습적 기계 환기 및 승압 치료 후 환자 결과에 대한 개별 맞춤형 영양 및 신체 활동을 결합한 조기 및 확장 재활 프로그램의 영향: 다기관 무작위 대조 시험

The NUTRIREA-4 trial will test the hypothesis that an individually tailored rehabilitation program combining nutritional therapy, physiotherapy, and physical activity and started early in the ICU then continued uninterruptedly throughout the post-ICU stay and at home after hospital discharge improves the long-term outcomes of critical-illness survivors, compared to usual care.

From ICU admission to recovery at home, the trial patients will receive either usual care or the early extended rehabilitation program. Usual care will consist in nutritional support and physiotherapy according to usual local practice in each participating ICU. The early extended program will consist of nutritional therapy, physiotherapy, and physical activity according to a standardized protocol tailored to general- and muscle-health improvements achieved in each individual patient over time.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

830

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Invasive mechanical ventilation (MV) started in the ICU within the past 24 h, or started before ICU admission with ICU admission within the past 24 h, and expected to be required for at least 48 hours after randomization
  • Treatment with a vasoactive agent for shock (adrenaline, dobutamine, or noradrenaline)
  • Nutritional support expected to be started within 24 h after intubation (or within 24 h after ICU admission if intubation occurred before ICU admission)
  • Age 18 or older
  • Patient and/or next-of-kin informed about the trial and having consented to participation in the trial. If the patient is unable to receive information and no next-of-kin can be contacted during screening for the trial, trial inclusion will be completed as an emergency procedure by the ICU physician, in compliance with French law.
  • Covered by the French public health-insurance system

Exclusion Criteria:

  • MV started more than 24 hours earlier
  • Specific nutritional needs, such as pre-existing long-term home enteral or parenteral nutrition for chronic bowel disease
  • Dying patient, do-not-resuscitate order, or other treatment- limitation decision at ICU admission
  • Social circumstances hindering follow-up and telephone/video consultations (no fixed address, non-European residence)
  • Inability to provide a stable personal mobile phone number (temporary number or not in the owner's name)
  • Communication difficulties via telephone or video consultation (pre-existing severe hearing or visual impairment)
  • Pre-existing chronic illness with life expectancy <6 months
  • Pre-existing cognitive impairment
  • Pre-existing spinal injury
  • Inability to walk before the critical illness
  • Acute or chronic neuromuscular disease
  • Brain injury, e.g., due to cardiac arrest, stroke, or severe trauma
  • Pregnancy, recent delivery, or lactation
  • Adult under guardianship
  • Correctional facility inmate
  • Institutionalized patient
  • Prior inclusion in a randomized trial designed to compare rehabilitation programs delivered to patients during critical illness

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Rehabilitation group

Individualized rehabilitation program
절차: Rehabilitation group

In the rehabilitation group, patients will follow an individualized rehabilitation program started early in the ICU and continued in the post-ICU ward then at home for 12 weeks, combining goal-directed nutrition and physical activity, tailored to gains made over time by each patient, with the involvement of dieticians, physiotherapists, and adapted-physical-activity instructors.
활성 비교기: Control group

Usual care
절차: Control group

In the control group, patients will receive usual care from day-0 to day-180.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
6-minute-walk distance
기간: 6 months

The primary endpoint is the 6-minute-walk distance (6MWD), in meters, assessed by blinded physicians and research nurses during a hospital visit 6 months after randomization.
6 months

2차 결과 측정

결과 측정
측정값 설명
기간
Handgrip strength
기간: 6 months after randomization

Handgrip strength (Kg and percent of predicted strength) at 6 months after randomization
6 months after randomization
Medical Research Council (MRC) score
기간: 6 months after randomization

MRC score at 6 months after randomization
6 months after randomization
Muscle mass assessed by the mid-arm muscle circumference (MAMC)
기간: 6 months after randomization

MAMC at 6 months after randomization
6 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
기간: 3 months after randomization

IPAQ-SF score at 3 months after randomization
3 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
기간: 4 months after randomization

IPAQ-SF score at 4 months after randomization
4 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
기간: 5 months after randomization

IPAQ-SF score at 5 months after randomization
5 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
기간: 6 months after randomization

IPAQ-SF score at 6 months after randomization
6 months after randomization
Physical activity assessed by the International Physical Activity Questionnaire Short Form (IPAQ-SF)
기간: 12 months after randomization

IPAQ-SF score at 12 months after randomization
12 months after randomization
Calorie intakes
기간: From day 0 to 12 months

Calorie intakes (daily mean during the hospital stay and at home at D90, D120, D150, D180, and one year after randomization)
From day 0 to 12 months
Protein intakes
기간: From day 0 to 12 months

Protein intakes (daily mean during the hospital stay and at home at D90, D120, D150, D180, and one year after randomization)
From day 0 to 12 months
Body weight
기간: 6 months

Mean changes in body weight measured at 6 months)
6 months
Mortality rates
기간: Day 90

90-day mortality rates
Day 90
Mortality rates
기간: 6 months

6-month mortality rates
6 months
Mortality rates
기간: 12 months

12-months mortality rates
12 months
Hypoglycemia
기간: From day 0 to day 7

Proportion of patients with at least one hypoglycemia from day 0 to day 7
From day 0 to day 7
Blood glucose
기간: From day 0 to day 7

Mean blood glucose from day 0 to day 7
From day 0 to day 7
Quality of life assessed using the Short Form 36 Health Survey (SF-36)
기간: 6 and 12 months

SF-36 scores 6 and 12 months after randomization
6 and 12 months
Handgrip strength
기간: ICU discharge, an average of 10 days

Handgrip strength (Kg and percent of predicted strength) at ICU discharge
ICU discharge, an average of 10 days
Handgrip strength
기간: Hospital discharge, an average of 20 days

Handgrip strength (Kg and percent of predicted strength) at hospital discharge
Hospital discharge, an average of 20 days
Medical Research Council (MRC) score
기간: ICU discharge, an average of 10 days

MRC score at ICU discharge
ICU discharge, an average of 10 days
Medical Research Council (MRC) score
기간: Hospital discharge, an average of 20 days

MRC score at hospital discharge
Hospital discharge, an average of 20 days
Muscle mass assessed by the mid-arm muscle circumference (MAMC)
기간: ICU discharge, an average of 10 days

MAMC at ICU discharge
ICU discharge, an average of 10 days
Muscle mass assessed by the mid-arm muscle circumference (MAMC)
기간: Hospital discharge, an average of 20 days

MAMC at hospital discharge
Hospital discharge, an average of 20 days
Body weight
기간: ICU discharge, an average of 10 days

Mean changes in body weight measured at ICU discharge
ICU discharge, an average of 10 days
Mortality rates
기간: ICU discharge, an average of 10 days

ICU discharge mortality rates
ICU discharge, an average of 10 days
Mechanical Ventilation (MV) duration
기간: From D0 until the date of cessation of mechanical ventilation, an average of 7 days

Days of MV
From D0 until the date of cessation of mechanical ventilation, an average of 7 days
ICU-acquired infection
기간: From day 0 until the date of discharge from ICU, an average of 10 days

Proportion of patients with at least one ICU-acquired infection
From day 0 until the date of discharge from ICU, an average of 10 days
ICU and hospital stay lengths
기간: From day 0 until the day of discharge from hospital, an average of 20 days

ICU and hospital stay lengths (days)
From day 0 until the day of discharge from hospital, an average of 20 days
Mortality rates
기간: Hospital discharge, an average of 20 days

Hospital discharge mortality rates
Hospital discharge, an average of 20 days
Insulin
기간: From day 0 until the date of ICU discharge, an average of 10 days

Days on insulin in the ICU
From day 0 until the date of ICU discharge, an average of 10 days
Delay from randomization to first standing-up
기간: From date of randomization until the date of first standing-up, an average of 7 days

Delay from randomization to first standing-up (days)
From date of randomization until the date of first standing-up, an average of 7 days
Delay from randomization to first walking
기간: From date of randomization until the date of first walking, an average of 15 days

Delay from randomization to first walking (days)
From date of randomization until the date of first walking, an average of 15 days

기타 결과 측정

결과 측정
측정값 설명
기간
Hospital Anxiety and Depression Scale (HADS)
기간: 6 and 12 months

HADS score 6 and 12 months after randomization
6 and 12 months
Post-traumatic stress disorder Check List for DSM-5 (PCL-5)
기간: 6 and 12 months

PCL-5 score 6 and 12 months after randomization
6 and 12 months
Resilience assessed using the Connor-Davidson Resilience Scale (CD-RISC10)
기간: 6 and 12 months

CD-RISC-10 6 and 12 months after randomization
6 and 12 months
Posttraumatic growth using the Posttraumatic Growth Inventory Short Form (PTGI-SF)
기간: 6 and 12 months

PTGI-SF 6 and 12 months after randomization
6 and 12 months
Cognitive performance using the Montreal Cognitive Assessment (MoCA)
기간: 6 and 12 months

MoCA 6 and 12 months after randomization
6 and 12 months
Qualitative assessment on how the rehabilitation program influences resilience and psychological recovery after ICU
기간: 12 months

Semi-structured interviews
12 months
Time course of circulating Growth-differentiation factor-15 (GDF-15)
기간: Inclusion, H24, H72, Day 7, ICU discharge, Day 180

GDF-15 plasma level
Inclusion, H24, H72, Day 7, ICU discharge, Day 180
Effects of the individualized rehabilitation program, compared to usual care, on IFN-γ
기간: Inclusion, H24, H72, Day7, ICU discharge, Day 180

IFN-γ plasma level
Inclusion, H24, H72, Day7, ICU discharge, Day 180
Effects of the individualized rehabilitation program, compared to usual care, on IFN-γ
기간: Inclusion, H24, H72, Day7, ICU discharge, Day 180.

IL-1β plasma level
Inclusion, H24, H72, Day7, ICU discharge, Day 180.
Effects of the individualized rehabilitation program, compared to usual care, on IL-6
기간: Inclusion, H24, H72, Day7, ICU discharge, Day 180

IL-6 plasma level
Inclusion, H24, H72, Day7, ICU discharge, Day 180
Effects of the individualized rehabilitation program, compared to usual care, on TNF-α
기간: Inclusion, H24, H72, Day7, ICU discharge, Day 180

TNF-α plasma level
Inclusion, H24, H72, Day7, ICU discharge, Day 180
Effects of the individualized rehabilitation program, compared to usual care, on FGF-21
기간: Inclusion, H24, H72, Day7, ICU discharge, Day 180

FGF-21 plasma level
Inclusion, H24, H72, Day7, ICU discharge, Day 180
Effects of the individualized rehabilitation program, compared to usual care, on leptin
기간: Inclusion, H24, H72, Day7, ICU discharge, Day 180

leptin plasma level
Inclusion, H24, H72, Day7, ICU discharge, Day 180
Effects of the individualized rehabilitation program, compared to usual care, on C-peptide
기간: inclusion, H24, H72, Day7, ICU discharge, Day 180

C-peptide plasma level
inclusion, H24, H72, Day7, ICU discharge, Day 180
Effects of the individualized rehabilitation program, compared to usual care, on Ghrelin
기간: Inclusion, H24, H72, Day7, ICU discharge, Day 180

Ghrelin plasma level
Inclusion, H24, H72, Day7, ICU discharge, Day 180

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Nantes University Hospital

수사관

  • 수석 연구원: Jean REIGNIER, MD, PhD, Nantes University Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 12월 14일

기본 완료 (추정된)

2027년 12월 14일

연구 완료 (추정된)

2028년 6월 14일

연구 등록 날짜

최초 제출

2024년 8월 20일

QC 기준을 충족하는 최초 제출

2024년 8월 29일

처음 게시됨 (실제)

2024년 9월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 29일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RC23_0585

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

De-identified individual participant data underlying the demographic characteristics and primary and secondary outcomes reported in the main publication, together with the data dictionary.

IPD 공유 기간

From 6 months after publication of the main trial results, for a period of 3 years

IPD 공유 액세스 기준

Data will be shared with qualified academic researchers upon reasonable request submitted to the principal investigator. Requests must include a scientifically sound research proposal and a signed Data Use Agreement (DUA).

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

구독하다