Evaluation of Novel Biomarkers in Early Recognition of Acute Kidney Injury After Orthopedic Operations.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Przemysław Bolewski
- 電話番号:0048225021721
- メール:klinanest1@wum.edu.pl
研究場所
-
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Mazowieckie
-
Otwock、Mazowieckie、ポーランド、05-400
- 募集
- Gruca Orthopaedic and Trauma Teaching Hospital
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コンタクト:
- Marek Janiak
-
Warsaw、Mazowieckie、ポーランド、02-005
- 募集
- I Department of Anesthesiology and Intensive Care Warsaw Medical University
-
コンタクト:
- Marek Janiak, MD
- 電話番号:0048225021724
- メール:klinanest1@wum.edu.pl
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- age at least 18 years
- be able to provide informed consent
Exclusion Criteria:
- end stage renal disease
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:コホート
- 時間の展望:見込みのある
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Any stage of acute kidney injury as defined by Kidney Diseases Improving Global Outcome
時間枠:120 hours
|
Concentration of novel biomarkers, its change and change of renal resistive index considering different stages of acute kidney injury
|
120 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Kidney perfusion evaluated by Renal Resistive Index (RRI)
時間枠:48 hours
|
Correlation between RRI and concentration of biomarkers
|
48 hours
|
|
Analysis of proenkephalin concentration
時間枠:24 hours
|
Change of proenkephalin concentration in the blood sample left at room temperature
|
24 hours
|
|
Kidney dysfunction and mortality
時間枠:30 days
|
Evaluation of 30-day need for renal replacement therapy, hospitalization due to kidney failure and/or mortality
|
30 days
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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