Early Nutrition in Acute Pancreatitis (OZT)
Very Early and Early Nutrition in Acute Pancreatitis in Children: a Randomized Study
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Warsaw, 폴란드, 02-091
- Departement of Paediatric Gastroenterology and Nutrition.
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
AP diagnosis according to the generally accepted criteria ie. fulfilling two out of three criteria:
- Abdominal pain of pancreatic origin
- Radiologic findings supportive of AP on imaging
- Amylase or lipase levels elevation three times above the upper limit of normal
- Mild or moderate AP Mild AP: AP without organ failure, local or general complications Moderate AP: AP that may be accompanied by intermittent organ failure, local complications or concomitant disease worsening
- No contradictions to enteral treatment
- Informed consent from the parents or legal guardian and from the patient if older than 16 years
Exclusion Criteria:
- Severe general condition
- Severe AP
- Kidney insufficiency, cardiac insufficiency
- Diabetes type 1
- Cystic fibrosis
- Contraindications to enteral feeding
- Lack of required informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Very early refeeding
Very early diet intervention: refeeding within 24 hours from the hospital admission. Participants will be encouraged to start eating immediately after the time of admission. They will be able to choose the meal from the list with no amount or calories restriction.They will be asked to conduct the daily diet diary - time of feeding, quality and quantity of the foods ingested. Laboratory tests will be performed at the study entry, on the day of 3 and 5 of hospitalization and on the day of discharge. |
Participant's diet includes several low-fiber and low-fat commonly available meals and products.
Patients will choose what they want to eat with no amount or calories restriction.
|
|
활성 비교기: Early refeeding
Early diet intervention: refeeding after 24 hours from the hospital admission . During the first 24 hours after admission participants will be on fluid only (orally and/or intravenously). Later on they will be encouraged to start eating. They will be able to choose the meal from the list with no amount or calories restriction.They will be asked to conduct the daily diet diary - time of feeding, quality and quantity of the foods ingested. Laboratory tests will be performed at the study entry, on the day of 3 and 5 of hospitalization and on the day of discharge. |
Participant's diet includes several low-fiber and low-fat commonly available meals and products.
Patients will choose what they want to eat with no amount or calories restriction.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Length of hospitalization
기간: through study completion, an average of 2 years
|
Number days of hospitalization
|
through study completion, an average of 2 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time between the onset of symptoms and the first feeding
기간: assessed at the day of 2
|
Time between the onset of symptoms and the first feeding measured in hours
|
assessed at the day of 2
|
|
Adverse events
기간: daily assessment in the first three days of hospitalization
|
Severity of abdominal pain daily using a 10 point visual - analog scale (VAS).
0 means lack of the pain, 10 means the most severe pain
|
daily assessment in the first three days of hospitalization
|
|
Average calories intake
기간: through study completion, an average of 2 years
|
Average calories intake (kcal)
|
through study completion, an average of 2 years
|
|
Levels of proinflammatory cytokine levels.
기간: through study completion, an average of 2 years
|
Proinflammatory cytokine levels (ng/ml) using ELISA tests
|
through study completion, an average of 2 years
|
|
Zonulin level
기간: through study completion, an average of 2 years
|
Zonulin level (ng/ml) using ELISA test
|
through study completion, an average of 2 years
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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. .
급성 췌장염에 대한 임상 시험
-
National Medical Research Center for Therapy and...Stupino Clinical Hospital, Moscow Region State Medical Institution완전한
Early diet intervention에 대한 임상 시험
-
Mondelēz International, Inc.KGK Science Inc.완전한
-
Fu Wai Hospital, Beijing, ChinaThe First Affiliated Hospital with Nanjing Medical University모집하지 않고 적극적으로
-
Saranas, Inc.Cardiovascular Research Foundation, New York; Proxima Clinical Research, Inc.완전한
-
Human Development Research Foundation, PakistanUniversity of Liverpool; Institute of Psychiatry, WHO Collaborating Center for Mental Health...완전한우울증 | 불안 | 심리적 고통 | 정서적 문제파키스탄
-
Drexel UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)모병
-
Shanghai Yueyang Integrated Medicine Hospital아직 모집하지 않음
-
Second Affiliated Hospital, School of Medicine,...모집하지 않고 적극적으로