- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05285709
Evaluation of Novel Biomarkers in Early Recognition of Acute Kidney Injury After Orthopedic Operations.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Przemysław Bolewski
- Numéro de téléphone: 0048225021721
- E-mail: klinanest1@wum.edu.pl
Lieux d'étude
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Mazowieckie
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Otwock, Mazowieckie, Pologne, 05-400
- Recrutement
- Gruca Orthopaedic and Trauma Teaching Hospital
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Contact:
- Marek Janiak
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Warsaw, Mazowieckie, Pologne, 02-005
- Recrutement
- I Department of Anesthesiology and Intensive Care Warsaw Medical University
-
Contact:
- Marek Janiak, MD
- Numéro de téléphone: 0048225021724
- E-mail: klinanest1@wum.edu.pl
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- age at least 18 years
- be able to provide informed consent
Exclusion Criteria:
- end stage renal disease
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Any stage of acute kidney injury as defined by Kidney Diseases Improving Global Outcome
Délai: 120 hours
|
Concentration of novel biomarkers, its change and change of renal resistive index considering different stages of acute kidney injury
|
120 hours
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Kidney perfusion evaluated by Renal Resistive Index (RRI)
Délai: 48 hours
|
Correlation between RRI and concentration of biomarkers
|
48 hours
|
|
Analysis of proenkephalin concentration
Délai: 24 hours
|
Change of proenkephalin concentration in the blood sample left at room temperature
|
24 hours
|
|
Kidney dysfunction and mortality
Délai: 30 days
|
Evaluation of 30-day need for renal replacement therapy, hospitalization due to kidney failure and/or mortality
|
30 days
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BIAKOR
Informations sur les médicaments et les dispositifs, documents d'étude
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