- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07636083
Acute Kidney Injury in Upper GI Bleeding Patients
Acute Kidney Injury Following Upper Gastrointestinal Bleeding: Incidence and Predictors
연구 개요
상세 설명
Upper gastrointestinal bleeding (UGIB) is a common medical emergency associated with significant morbidity and mortality. Acute kidney injury (AKI) is frequently observed in these patients, mainly due to hypovolemia and renal hypoperfusion. Despite its clinical importance, data regarding AKI incidence and predictors in UGIB patients, particularly in Middle Eastern populations, remain limited.
This prospective observational study aims to assess renal function abnormalities and identify predictors of AKI in patients with UGIB, including both variceal and non-variceal causes. The study will also evaluate clinical outcomes such as mortality, hospital stay duration, and need for renal replacement therapy.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Sohag, 이집트
- Sohag university hospitals
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Adult patients aged 18 years or older
- Patients presenting with clinical features suggestive of acute upper gastrointestinal bleeding (UGIB), including hematemesis, coffee-ground vomiting, or melena
- Diagnosis of UGIB confirmed by upper gastrointestinal endoscopy or strong clinical evidence when endoscopy is not immediately available
- Patients admitted to Sohag University Hospitals (medical wards or intensive care unit)
- Availability of renal function data, including at least one serum creatinine measurement at admission and serial measurements during hospitalization
- Availability of baseline renal function (previous serum creatinine within 3-12 months) or estimable baseline during hospitalization
Exclusion Criteria:
- Patients with end-stage renal disease (ESRD) on chronic dialysis
- Patients with a history of renal transplantation
- Patients with advanced chronic kidney disease stage 5 (eGFR <15 mL/min/1.73 m²) not on dialysis
- Patients with lower gastrointestinal bleeding
- Patients with incomplete or missing essential renal function data
- Patients discharged or deceased within 24 hours of hospital admission
- Pregnant patients
- Patients with acute kidney injury at presentation due to causes other than UGIB
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Patients with Acute Upper Gastrointestinal Bleeding
Adult patients (≥18 years) presenting with acute upper gastrointestinal bleeding (UGIB) and admitted to Sohag University Hospitals.
Patients will be followed prospectively to assess the incidence of acute kidney injury (AKI) and its predictors.
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No therapeutic intervention is applied.
Patients are managed according to standard hospital care, and data are collected observationally.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Acute Kidney Injury (AKI) According to KDIGO Criteria
기간: From hospital admission through hospital discharge, up to 30 days
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The incidence of acute kidney injury (AKI) among patients presenting with acute upper gastrointestinal bleeding (UGIB), defined according to KDIGO criteria based on changes in serum creatinine and/or urine output during hospitalization.
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From hospital admission through hospital discharge, up to 30 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Patients Developing AKI According to Bleeding Etiology
기간: Baseline (hospital admission) with AKI occurrence assessed through hospital discharge, up to 30 days
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Comparison of AKI incidence between variceal and non-variceal UGIB patients.
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Baseline (hospital admission) with AKI occurrence assessed through hospital discharge, up to 30 days
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Change in Serum Creatinine Concentration
기간: Through hospital discharge, up to 30 days
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Serum creatinine concentration (mg/dL) measured at admission and during hospitalization to assess changes in renal function.
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Through hospital discharge, up to 30 days
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SOHAG-UGIB-AKI-26
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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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