NCT02921113

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

September 29, 2016

Last Update Submit

September 5, 2017

Conditions

Acute Kidney Injury

Keywords

suPARAcute Kidney InjuryOn-Pump Cardiac SurgeryBiomarker

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for elective on-pump cardiac surgery with no known kidney disease

You may qualify if:

  • Approved informed concent Age higher than 18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Marmara University School of Medicine

Istanbul, 34890, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 21133700BACKGROUND

  • 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.

    PMID: 9054745RESULT

  • 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.

    PMID: 21804539RESULT

  • 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.

    PMID: 23100007RESULT

  • 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.

    PMID: 15312219RESULT

Biospecimen

Retention: SAMPLES WITH DNA

plasma(suPAR) plasma(NGAL) urine NGAL serum creatinine plasma Cystatine C

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Bünyamin KIR, M.D

    Marmara University School of Medicine Dept of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

  • İsmail Cinel, Prof. M.D

    Marmara University School of Medicine Dept of Anesthesiology and Reanimation

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2016

First Posted

September 30, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

September 8, 2017

Record last verified: 2017-09

Locations

TU(1)