Acute Kidney InjuryNCT02921113
suPAR in the Early Diagnosis of Acute Kidney Injury(AKI) After On-Pump Cardiac Surgery
An observational study of Acute Kidney Injury, run by Marmara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2016to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective on-pump cardiac surgery with no known kidney disease
Who may be able to join
- Approved informed concent Age higher than 18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Anesthesiology, Marmara University School of Medicine
Istanbul, 34890
About this study
Official title: 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.
- Conditions
- Acute Kidney Injury
- Keywords
- suPAR, Acute Kidney Injury, On-Pump Cardiac Surgery, Biomarker
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bünyamin KIR, M.D, Principal investigator, Marmara University School of Medicine Dept of Anesthesiology and Reanimationİsmail Cinel, Prof. M.D, Study director, Marmara University School of Medicine Dept of Anesthesiology and ReanimationBeliz Bilgili, Asst. Prof., Principal investigator, Marmara University School of Medicine Dept. of Anesthesiology and ReanimationSinan Arsan, Prof. M.D, Principal investigator, Marmara University School of Medicine Dept. of Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921113
- Sponsor's protocol ID
- 09.2016.236
- Status last verified
- Sep 2017
- First submitted
- 29 Sep 2016
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21133700Chertow 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.
PubMed 9054745Wei 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.
PubMed 21804539Jalkanen 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.
PubMed 23100007Bellomo 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.
PubMed 15312219
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble Urokinase Plasminogen Activator Receptor (suPAR) in the Early Diagnosis of Acute Kidney Injury After On-Pump Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02921113
- Acronym / sponsor ID
- 09.2016.236
- Conditions
- Acute Kidney Injury
- Keywords
- suPAR, Acute Kidney Injury, On-Pump Cardiac Surgery, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective on-pump cardiac surgery with no known kidney disease
Key inclusion criteria (1 listed)
- Approved informed concent Age higher than 18 years old
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Background: PubMed 21133700Khan E, Batuman V, Lertora JJ. Emergence of biomarkers in nephropharmacology. Biomark Med. 2010 Dec;4(6):805-14. doi: 10.2217/bmm.10.115.
- Results publication: PubMed 9054745Chertow 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.
- Results publication: PubMed 21804539Wei 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.
- Results publication: PubMed 23100007Jalkanen 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.
- Results publication: PubMed 15312219Bellomo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bünyamin KIR, M.D principal investigator
Marmara University School of Medicine Dept of Anesthesiology and Reanimation
İsmail Cinel, Prof. M.D study director
Marmara University School of Medicine Dept of Anesthesiology and Reanimation
Beliz Bilgili, Asst. Prof. principal investigator
Marmara University School of Medicine Dept. of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Injury (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02921113, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2017.