- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07637435
Role of Vascular Endothelial Markers in Predicting Renal Prognosis and Mortality in Patients Undergoing HD-AKI (VEMhemodiAKI)
The Role of Vascular Endothelial Markers in Predicting Renal Function Prognosis and Mortality in Patients Undergoing Emergency Hemodialysis Due to Acute Kidney Injury
The aim of this study was to evaluate the role of Activin A, Nostrin, and Angiopoetin-2 levels in predicting the prognosis of renal function and in-hospital and 6-month mortality in patients undergoing emergency hemodialysis treatment for acute kidney injury. The main questions it aims to answer are:
Acute renal injury is a clinical entity with very important consequences. Mortality and morbidity are high in patients requiring hemodialysis. This study aims to evaluate the predictive effects of certain biomarkers on outcomes such as short- and long-term monitoring of renal function, weaning or continuation of hemodialysis, in-hospital and 6-month mortality in these patients. In patients with an indication for emergency hemodialysis, the following levels will be measured before hemodialysis:
- Serum Activin A,
- Serum Nostrin,
- Serum Angiopoetin-2
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Menteşe
-
Muğla, Menteşe, Turkiet (Türkiye), 48000
- Mugla Sitki Kocman University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Patients 18 years and older of age requiring hemodialysis for acute kidney injury
Exclusion Criteria:
- Patients under 18 years of age
- Patients under chronic renal replacement therapy
- Patients with a history of renal transplantation
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: AKI-HD GROUP
Acute kidney injury (undergoing hemodialysis) arm.
The only group in the study.
Measurement of serum Activin A, serum Nostrin, serum Angiopoetin-2
|
Except from taking a venous blood sample there are no interventions.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Correlation of serum nostrin, activin A, angiopoetin-2 levels and in-hospital clinical results and outcomes (mortality, weaning from HD)
Tidsram: From the day of the first hemodialysis session until in-hospital death or discharge. (maximum up to 100 days)
|
Up to 3 months were sufficient for patient recruitment for the study.
After patient recruitment was completed, the investigators followed the patients during their in-hospital days monitoring their need for hemodialysis and survival/death status.
|
From the day of the first hemodialysis session until in-hospital death or discharge. (maximum up to 100 days)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
All cause mortality and need for hemodialysis or weaning from hemodialysis
Tidsram: 180 days after the initiation of first hemodialysis session
|
Patients who were discharged from the hospital after the initiation of hemodialysis were followed up for 180 days in terms of discontinuing or continuing hemodialysis treatment and survival/death status.
|
180 days after the initiation of first hemodialysis session
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Alper Alp, Assoc Prof,MD, Muğla Sıtkı Koçman University
Publikationer och användbara länkar
Allmänna publikationer
- Erfurt S, Lauxmann M, Asmus K, Oess S, Patschan D, Hoffmeister M. Serum Nostrin-A risk factor of death, kidney replacement therapy and acute kidney disease in acute kidney injury. PLoS One. 2024 Apr 11;19(4):e0299131. doi: 10.1371/journal.pone.0299131. eCollection 2024.
- Kovacevic I, Hu J, Siehoff-Icking A, Opitz N, Griffin A, Perkins AC, Munn AL, Muller-Esterl W, Popp R, Fleming I, Jungblut B, Hoffmeister M, Oess S. The F-BAR protein NOSTRIN participates in FGF signal transduction and vascular development. EMBO J. 2012 Aug 1;31(15):3309-22. doi: 10.1038/emboj.2012.176. Epub 2012 Jun 29.
- Robinson-Cohen C, Katz R, Price BL, Harju-Baker S, Mikacenic C, Himmelfarb J, Liles WC, Wurfel MM. Association of markers of endothelial dysregulation Ang1 and Ang2 with acute kidney injury in critically ill patients. Crit Care. 2016 Jul 3;20(1):207. doi: 10.1186/s13054-016-1385-3.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 25/22
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