- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00495859
Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation (PROUD)
Randomized Controlled Double Blind Multi-Center Clinical Trial to Assess the Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation
연구 개요
상태
상세 설명
Background. Patients with end stage liver disease characteristically are malnourished which is associated with poor outcome. Formulas enriched with arginine, ω-3 fatty acids, and nucleotides, "immunonutrients", potentially improve their nutritional status. This study is designed to evaluate the clinical outcome of long-term "immunonutrition" of patients with end-stage liver disease while on the waiting list for liver transplantation.
Methods / design. A randomized controlled double blind multi-center clinical trial with two parallel groups comprising a total of 142 newly registered patients for primary liver transplantation has been designed to assess the safety and efficacy of the long-term administration of ORAL IMPACT®, an "immunonutrient" formula, while waiting for a graft. Patients will be enrolled the day of registration on the waiting list for liver transplantation. Study ends on the day of transplantation. Primary endpoints include patients' nutritional and physiological status, as measured by mid-arm muscle area, triceps skin fold thickness, grip strength, and fatigue score, as well as patients' health related quality of life. Furthermore, patients will be followed for 12 postoperative weeks to evaluate anabolic recovery after transplantation as shown by reduced post-transplant mechanical ventilation, hospital stay, wound healing, infectious morbidities (pneumonia, intra-abdominal abscess, sepsis, line sepsis, wound infection, and urinary tract infection), acute and chronic rejection, and mortality.
Discussion. Formulas enriched with arginine, ω-3 fatty acids, and nucleotides have been proven to be beneficial in reducing postoperative infectious complications and length of hospital stay among the patients undergoing elective gastrointestinal surgery. Possible mechanisms include downregulation of the inflammatory responses to surgery and immune modulation rather than a sole nutritional effect.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Baden-Württemberg
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Heidelberg, Baden-Württemberg, 독일, 69120
- 모병
- Department of Surgery, Ruprecht-Karls University
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연락하다:
- Peter Schemmer, MD
- 전화번호: +4962215636500
- 이메일: peter.schemmer@med.uni-heidelberg.de
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연락하다:
- Arash Nickkholgh, MD
- 전화번호: +4962215638584
- 이메일: arash.nickkholgh@med.uni-heidelberg.de
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수석 연구원:
- Peter Schemmer, MD
-
부수사관:
- Arash Nickkholgh, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Men and women between 18 and 68 years of age
- Scheduled for first liver transplantation
- Written informed consent
- Protein-calorie malnutrition: Mid-arm muscle area (MAMA) <85% standard
Exclusion Criteria:
- Patients < 18 and > 68 years
- Pregnant or nursing women
- History of hypersensitivity to arginine, ω-3 fatty acids, or nucleotides
- Inability to take oral nutrition
- Patients with fulminant or subacute hepatic failure requiring urgent transplantation
- Mental condition rendering the subject incapable to understand the nature, scope, and consequences of the trial
- Simultaneous participation in another clinical trial
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: 1
Study group will receive formula enriched with arginine, ω-3 fatty acids, and nucleotides once daily
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food for special medical purpose (FSMP)
다른 이름들:
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활성 비교기: 2
controls receive an isocaloric isonitrogenous non-specific nutritional support
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an isocaloric isonitrogenous non-specific nutritional support
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
improved patients' nutritional and physiological status, fatigue score, as well as patients' health related quality of life.
기간: while in the waiting list for liver transplantation
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while in the waiting list for liver transplantation
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2차 결과 측정
결과 측정 |
기간 |
---|---|
enhanced anabolic recovery after transplantation as shown by reduced post-transplant morbidities and mortalities
기간: the first 12 posttransplant weeks
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the first 12 posttransplant weeks
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Peter Schemmer, MD, Department of Surgery, Ruprecht-Karls University of Heidelberg, Germany
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PROUD
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