- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05285709
Evaluation of Novel Biomarkers in Early Recognition of Acute Kidney Injury After Orthopedic Operations.
연구 개요
상세 설명
Extensive orthopedic surgical procedures may have many postoperative complications. One of those, sometimes overlooked, is acute kidney injury. Classically defined by KDIGO criteria as an increase in creatinine concentration, may go by unnoticed due to a late peak in serum concentration of this marker. There is still need for "nephrological troponin" which could easily and with a low margin of doubt identify acute kidney injury.
The investigators have planned a double-center study, in cooperation with the 'Department of Anesthesiology and Intensive Therapy with the Postoperative Subdivision' of the 'Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy CMKP' in Otwock, concentrating on measuring concentration of biomarkers known to indicate acute kidney injury in different situations: Proenkephalin (PENK), Dickkopf-3 (DKK3), circular RNA (circRNA), Liver-type Fatty Acid-binding Protein (L-FABP), Netrin-1, semaphorin 3a, Tissue Inhibitor of Matrix Metalloproteinase-2 (TIMP-2), Insulin-like Growth Factor-binding Protein 7 (IGFBP-7), Retinol-binding Protein-4 (RBP-4) aiming to find a marker, or group of markers that would allow recognition of renal injury at an early stage to help minimize the effect.
Patients aged at least 18 years, with a hip fracture undergoing, either hip alloplasty, or internal fixation, after providing informed consent, will be included. Patients with end stage renal disease will be excluded. Blood and urine samples will be collected at 5 points of time: 1 - after admission to the operating ward, 2 - following surgery, before leaving the operating ward, 3 - on the 1st postoperative day, 4 - on the 2nd postoperative day, 5 - on the 5th postoperative day, or the day the patient leaves hospital, whichever is first. Additionally patients who will be able to cooperate will have a renal resistive index measured using ultrasonography.
Blood collected from patients, not longer than 8 hours after collection will be tested for PENK concentration (Spingotec GmbH, Berlin, Germany), then plasma obtained from this sample after centrifuging will be frozen together with centrifugated samples of urine in -80 degrees Celsius till analysis.
Additionally, if the concentration of PENK is elevated, the same sample will be tested after 8, 12 and 24 hours of staying at room temperature, to define stability of the test from blood sampling till measurement.
30 days after surgery, an attempt to contact the patient or his/her family is going to be made, to check if the patient has developed need for renal replacement therapy or has required hospitalisation due to kidney dysfunction together with a 30 day mortality evaluation.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Przemysław Bolewski
- 전화번호: 0048225021721
- 이메일: klinanest1@wum.edu.pl
연구 장소
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Mazowieckie
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Otwock, Mazowieckie, 폴란드, 05-400
- 모병
- Gruca Orthopaedic and Trauma Teaching Hospital
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연락하다:
- Marek Janiak
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Warsaw, Mazowieckie, 폴란드, 02-005
- 모병
- I Department of Anesthesiology and Intensive Care Warsaw Medical University
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연락하다:
- Marek Janiak, MD
- 전화번호: 0048225021724
- 이메일: klinanest1@wum.edu.pl
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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:
- age at least 18 years
- be able to provide informed consent
Exclusion Criteria:
- end stage renal disease
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Any stage of acute kidney injury as defined by Kidney Diseases Improving Global Outcome
기간: 120 hours
|
Concentration of novel biomarkers, its change and change of renal resistive index considering different stages of acute kidney injury
|
120 hours
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Kidney perfusion evaluated by Renal Resistive Index (RRI)
기간: 48 hours
|
Correlation between RRI and concentration of biomarkers
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48 hours
|
|
Analysis of proenkephalin concentration
기간: 24 hours
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Change of proenkephalin concentration in the blood sample left at room temperature
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24 hours
|
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Kidney dysfunction and mortality
기간: 30 days
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Evaluation of 30-day need for renal replacement therapy, hospitalization due to kidney failure and/or mortality
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30 days
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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. .
고관절 골절에 대한 임상 시험
Biomarker에 대한 임상 시험
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