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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02921113
Other study ID # 09.2016.236
Secondary ID
Status Completed
Phase N/A
First received September 29, 2016
Last updated September 5, 2017
Start date April 2016
Est. completion date May 2017

Study information

Verified date September 2017
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date May 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Department of Anesthesiology, Marmara University School of Medicine Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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 Confere — View Citation

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. — View Citation

Jalkanen V, Yang R, Linko R, Huhtala H, Okkonen M, Varpula T, Pettilä 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 — View Citation

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. Review. — View Citation

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, Rastal — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Acute Kidney Injury 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. 2 days
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