- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02921113
suPAR in the Early Diagnosis of Acute Kidney Injury(AKI) After On-Pump Cardiac Surgery
September 5, 2017 updated by: Marmara University
Soluble Urokinase Plasminogen Activator Receptor (suPAR) in the Early Diagnosis of Acute Kidney Injury After On-Pump Cardiac Surgery
Acute Kidney Injury(AKI) is of the serious complications in patients with undergoing on-pump cardiac surgery.
End stage kidney failure requiring dialysis therapy after cardiac surgery is associated with more than 60% mortality rate.
Involvement of AKI after on-pump cardiac surgery increases the mortality rate 19 times.
suPAR is one of the novel biomarker which has potential prognostic value for renal dysfunction in patients with undergoing on-pump cardiac surgery.
Early diagnosis and prompt intervention to prevent AKI has great importance for management of postoperative cardiac patients.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
105
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34890
- Department of Anesthesiology, Marmara University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients scheduled for elective on-pump cardiac surgery with no known kidney disease
Description
Inclusion Criteria:
- Approved informed concent Age higher than 18 years old
Exclusion Criteria:
- Chronic kidney disease Renal transplantation Cancer history Previous cardiac surgery Sepsis Liver failure Thyroid dysfunction Having long term steroid therapy Having renal replacement therapy Exposure to nephrotoxic drug and radiocontrast substance before 5 days of surgery Diagnosis of Acute Kidney Injury Intraaortic balloon or Extracorporeal Membrane Oxygenation insertion after surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Kidney Injury
Time Frame: 2 days
|
Patients will be classified as AKI patients and non-AKI patients according to KDIGO classification.
AKI patients will be subdivided into 3 subgroup according to KDIGO criteria.
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2 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bünyamin KIR, M.D, Marmara University School of Medicine Dept of Anesthesiology and Reanimation
- Study Director: İsmail Cinel, Prof. M.D, Marmara University School of Medicine Dept of Anesthesiology and Reanimation
- Principal Investigator: Beliz Bilgili, Asst. Prof., Marmara University School of Medicine Dept. of Anesthesiology and Reanimation
- Principal Investigator: Sinan Arsan, Prof. M.D, Marmara University School of Medicine Dept. of Cardiovascular Surgery
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Khan E, Batuman V, Lertora JJ. Emergence of biomarkers in nephropharmacology. Biomark Med. 2010 Dec;4(6):805-14. doi: 10.2217/bmm.10.115.
- Chertow GM, Lazarus JM, Christiansen CL, Cook EF, Hammermeister KE, Grover F, Daley J. Preoperative renal risk stratification. Circulation. 1997 Feb 18;95(4):878-84. doi: 10.1161/01.cir.95.4.878.
- Wei C, El Hindi S, Li J, Fornoni A, Goes N, Sageshima J, Maiguel D, Karumanchi SA, Yap HK, Saleem M, Zhang Q, Nikolic B, Chaudhuri A, Daftarian P, Salido E, Torres A, Salifu M, Sarwal MM, Schaefer F, Morath C, Schwenger V, Zeier M, Gupta V, Roth D, Rastaldi MP, Burke G, Ruiz P, Reiser J. Circulating urokinase receptor as a cause of focal segmental glomerulosclerosis. Nat Med. 2011 Jul 31;17(8):952-60. doi: 10.1038/nm.2411.
- Jalkanen V, Yang R, Linko R, Huhtala H, Okkonen M, Varpula T, Pettila V, Tenhunen J; FINNALI Study Group. SuPAR and PAI-1 in critically ill, mechanically ventilated patients. Intensive Care Med. 2013 Mar;39(3):489-96. doi: 10.1007/s00134-012-2730-x. Epub 2012 Oct 26.
- Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
September 29, 2016
First Submitted That Met QC Criteria
September 29, 2016
First Posted (Estimate)
September 30, 2016
Study Record Updates
Last Update Posted (Actual)
September 8, 2017
Last Update Submitted That Met QC Criteria
September 5, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2016.236
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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