- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04693962
FGF23 as a Marker of Acute Kidney Injury
Fibroblast Growth Factor-23 as a Marker of Acute Kidney Injury After Partial Nephrectomy
A partial nephrectomy (PN) preserves renal parenchyma with a proper oncology outcome. PN is performed during transitory ischemia to avoid massive bleeding during tumor resection. Nevertheless, the transitory ischemia might cause an acute kidney injury(AKI). AKI diagnose is based on the increase in plasma creatinine concentration and a decrease in urine output. However, both plasma creatinine concentration and diuresis are useful for the diagnose, but not in the detection of the risk patients. Therefore, there is considerable interest to find a biomarkers of kidney injury that allow clinicians to predict the development of AKI. Hence, we propose Fibroblastic Growth Factor-23 (FGF23) as a novel early biomarker to detect patients in risk to develop postoperative AKI after a PN.
We will conduct an observational and prospective study in three different groups of patients: PN gropup, patients who underwent PN with a transient and controlled renal ischemia injury using a renal artery clamping; Hemicolectomy (HC) group, patients as non-renal ischemia surgery controls, with similar demographic characteristics, but submitted to HC; and Nephrolithotomy (NL) group, patients who underwent NL, as a control of kidney surgery with physical injury.
In each patient, a time curve of plasmatic creatinine, blood urea nitrogen (BUN), and FGF23 were measure.
Our study aims to describe the role of FGF23 as an early biomarker of AKI after PN, where patients are exposed to a controlled ischemic injury.
연구 개요
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Santiago, 칠레
- 모병
- Hospital Clinic Universidad de Chile
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연락하다:
- Nicolas J Valls, MD
- 전화번호: +56933741332
- 이메일: nvallsj@hotmail.com
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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:
- American Society of Anesthesiology physical status (ASA) I or II.
- Normal preoperative plasma creatinine level
- Baseline estimated glomerular filtration rate (eGFR) > 60 ml/min per 1.73 m2.
Exclusion Criteria:
- History of chronic kidney disease
- Anemia
- Alterations in the parathormone or vitamin D axis
- Pregnant women
- Subjects with concomitant use of nephrotoxic drugs.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
Partial Nephrectomy (PN)
Patients that will undergo PN with a transient and controlled renal ischemia injury using a renal artery clamping.
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Plasma levels of FGF-23 will be measured by ELISA
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Hemicolectomy (HC)
Patients who will undergo HC, as non-renal ischemia surgery controls, with similar demographic characteristics, but submitted to HC.
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Plasma levels of FGF-23 will be measured by ELISA
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Nephrolithotomy (NL)
Patients who undergo NL as non-renal ischemia surgery controls but with kidney physical injury
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Plasma levels of FGF-23 will be measured by ELISA
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Acute Kidney Injury
기간: 72 hours
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Patients that develop postoperative acute kidney injury
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72 hours
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
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 신장 손상에 대한 임상 시험
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The Second Hospital of Qinhuangdao완전한
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National Health Service, United KingdomUniversity of Bradford완전한