Study to Assess the Prognostic Value of the Antithrombin III in the Acute Pancreatitis (AT-PROPANC) (AT-PROPANC)
Epidemiologic , Observational, Prospective Study to Assess the Prognostic Value of the Antithrombin III in the Development of Moderate or Severe Acute Pancreatitis (AT-PROPANC)
연구 개요
상태
정황
상세 설명
This is an epidemiological, observational, prospective, multicentric study in 400 adult patients admitted to hospital for mild acute pancreatitis to to assess the prognostic value of the antithrombin III in the development of moderate or severe acute pancreatitis.
In the context of clinical practice of general surgery and apparatus digestive services, patients entering with mild acute pancreatitis will be asked to participate in the study and if so, they will sign the informed consent.
On admission, demographic and anthropometric data of the patient will be recorded, as well as medical history, patient's admission data and vital signs. Patient's blood will be drawn for analysys and the risk of organ failure will be measured by modified Marshall and Apache II scales. The assessments and procedures performed are the standard practice at the center.
At 24 hours (± 3 hours) and at 7 days (or nine days to avoid weekends) after admisison, vital signs will be recorded, laboratory tests will be performed and the risk of organ failure will be measured by modified Marshall and Apache II scales.
At discharge of the patient (regardless of when it occurs), the outcome of the acute pancreatitis will be recorded.
. Those patients discharged within the first month after admission will be visited or called (according to standard practice at the center) one month after arrival, to record follow-up data, including health condition, readmissions and abdominal pain evaluation by visual analog scale.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Barcelona
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Sabadell, Barcelona, 스페인, 08208
- 모병
- Corporacio Sanitaria Parc Tauli
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연락하다:
- Francisco Javier -García Borobia, Dr.
- 전화번호: 21461 +34 93 7231010
- 이메일: fjgarcia@tauli.cat
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수석 연구원:
- Francisco Javier García Borobia, Dr.
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Sant Joan Despí, Barcelona, 스페인, 08970
- 모병
- Hospital de Sant Joan Despí Moisès Broggi
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연락하다:
- Robert Memba, Dr.
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수석 연구원:
- Robert Memba, Dr.
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients diagnosed with mild acute pancreatitis according to seriousness criteria established by Banks et al, 2013.
- Patients of either sex aged ≥ 18 years .
- Patients who have given their written informed consent
Exclusion Criteria:
- Patients with exacerbated chronic pancreatitis.
- Patients with coagulation disorders (congenital and acquired antithrombin deficiency) .
- Patients with liver cirrhosis.
- Pregnant patients
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
antithrombin III levels vs maximum seriousness grade of acute pancreatitis
기간: At Admission and at 24h
|
Levels of antithrombin III at admission and at 24h will be related with maximum seriousness grade of acute pancreatitis reached during patient's admission at site by logistic regression models
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At Admission and at 24h
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
result of modified Marshall and Apache II scales
기간: Admission and at 24h
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Admission and at 24h
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|
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antithrombin III levels vs mortality
기간: From date of admission until the end of study or date of death from any cause, whichever came first, assessed up to 1 month"
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Levels of antithrombin III at admission and at 24h will be related with mortality rates by logistic regression models
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From date of admission until the end of study or date of death from any cause, whichever came first, assessed up to 1 month"
|
|
antithrombin III levels vs organic failure
기간: From date of admission until the end of study or date of organic failure, whichever came first, assessed up to 1 month"
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Levels of antithrombin III at admission and at 24h will be related with organic failure rates by logistic regression models
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From date of admission until the end of study or date of organic failure, whichever came first, assessed up to 1 month"
|
|
antithrombin III levels vs necrosis and infection rates
기간: From date of admission until the end of study or date of necrosis or infection diagnosis, whichever came first, assessed up to 1 month"
|
Levels of antithrombin III at admission and at 24h will be related with necrosis and infection rates by logistic regression models
|
From date of admission until the end of study or date of necrosis or infection diagnosis, whichever came first, assessed up to 1 month"
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Francisco Javier García Borobia, Dr., Corporacion Parc Tauli
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (예상)
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
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