- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Menteşe
-
Muğla, Menteşe, Turkey (Türkiye), 48000
- Mugla Sitki Kocman University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation of serum nostrin, activin A, angiopoetin-2 levels and in-hospital clinical results and outcomes (mortality, weaning from HD)
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All cause mortality and need for hemodialysis or weaning from hemodialysis
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alper Alp, Assoc Prof,MD, Muğla Sıtkı Koçman University
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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