Acute Kidney InjuryNCT03457987
Acute Kidney Injury After Cardiac Surgery
An observational study of Acute Kidney Injury, run by University of Giessen at 1 site in Germany.
Trial summary
The investigators seek to determine whether a reduced preoperative renal functional reserve predicts postoperative acute kidney injury in patients with normal estimated glomerular filtration rates undergoing elective cardiac surgery. 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
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2018to 21 Jan 2023
- 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: Adults undergoing elective cardiac surgery (with or without cardiopulmonary bypass) with an estimated GFR ≥60 ml/min/1.73 m2 (CKD-Epidemiology Collaboration equation)
Who may be able to join
- Subjects older than 18 years
- Subjects undergoing elective cardiac surgery (with or without cardiopulmonary bypass)
- Subjects with an estimated GFR ≥60 ml/min/1.73 m2 (CKD-Epidemiology Collaboration equation)
- Subjects who signed informed consent forms
Who cannot join
- Preexisting acute kidney injury (as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days)
- Chronic kidney disease ≥ stage III (KDIGO)
- Subjects undergoing transcatheter aortic valve implantation (TAVI)
- Pregnancy
- Solitary kidney
- Diabetes mellitus type 1
Show all 22Show fewer
- Recent cardiac arrest (within last 3 months)
- Liver failure or cirrhosis
- Total parenteral nutrition
- Hemoglobin <11 g/dl
- Sepsis
- History of malabsorption, chronic inflammatory bowel disease, short bowel, or pancreatic insufficiency
- Transplant donor or recipient
- Active autoimmune disease with renal involvement
- Rhabdomyolysis
- Prostate hypertrophy with International Prostate Symptom Score ≥20
- Active neoplasm
- Decompensated heart failure / inability to pause angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers minimum 2 days before protein load
- Known iodine allergy (exclusion criteria only for those centres who use iohexol plasma clearance for determination of GFR)
- TSH <0.3 µU/l (exclusion criteria only for those centres who use iohexol)
- Subjects who received intravenous radiocontrast agents within the 72 hours before the protein load
- Subjects who received NSAIDs within 48 hours before the protein load
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Clinic Giessen and Marburg - Campus Giessen
Giessen, Hesse, 35392
About this study
Official title: Preoperative Renal Functional Reserve to Predict Risk of Acute Kidney Injury After Cardiac Surgery: The IRRIV Task Force and Collaborators for the Prevention of Acute Kidney Injury
The investigators seek to determine whether a reduced preoperative renal functional reserve predicts postoperative acute kidney injury in patients with normal estimated glomerular filtration rates undergoing elective cardiac surgery.
Read the detailed description
Although acute kidney injury (AKI) frequently complicates cardiac surgery, methods to determine AKI risk in patients without underlying kidney disease are lacking. Renal functional reserve (RFR) can be used to measure the capacity of the kidney to increase glomerular filtration rate under conditions of physiological stress and may serve as a functional marker that assesses susceptibility to injury.
The investigators seek to determine whether a reduced preoperative RFR predicts postoperative AKI in patients with normal estimated glomerular filtration rates undergoing elective cardiac surgery. All centres will measure RFR with creatinine clearance, except University Hospital Giessen where in addition iohexol plasma-clearance will be used.
- Conditions
- Acute Kidney Injury
- Keywords
- protein load, cardiac surgery
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether a reduced preoperative RFR ≤15 ml/min/1.73 m2 increased the odds ratio for postoperative acute kidney injury in patients undergoing elective cardiac surgery.
Renal functional reserve
Measured: Preoperative
Secondary outcomes (9)
determine preoperative RFR accuracy based on receiver operating characteristic curve curve to predict acute kidney injury.
Renal functional reserve
Measured: Preoperative
To analyze an acute kidney injury risk prediction model based on clinical covariates.
Renal functional reserve
Measured: Preoperative
Mortality at 30 and 90 days
Mortality
Measured: 30 and 90 days after surgery
Length of stay in intensive care unit and hospital.
Hospital stay
Measured: Postoperative
Use and duration of renal replacement therapy during hospital stay.
Renal replacement therapy
Measured: Postoperative
Renal replacement therapy dependence at days 30 and 90.
Renal replacement therapy
Measured: 30 and 90 days after surgery
To evaluate renal function at three months after surgery.
Estimated glomerular filtration rate
Measured: 3 months after surgery
To evaluate whether preoperative RFR is correlated to renal function at three months after surgery.
Renal functional reserve
Measured: Preoperative
To evaluate whether chronic kidney disease is associated to preoperative RFR.
Renal functional reserve
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start1 Mar 2018
- Primary completion23 Jun 2022
- Study completion21 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Shanghai Jiao Tong University School of Medicine, Robert Bosch Medical Center, Ospedale San Bortolo di Vicenza, Azienda Ospedaliero Universitaria Maggiore della Carita, Charite University, Berlin, Germany
- Responsible party
- Principal investigator, Faeq Husain-Syed, University of Giessen
- Investigators
- Claudio Ronco, MD, Study director, San Bortolo Hospital, Vicenza, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457987
- Sponsor's protocol ID
- AZ 216/17
- Status last verified
- Jun 2022
- First submitted
- 1 Mar 2018
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Husain-Syed F, Ferrari F, Sharma A, Danesi TH, Bezerra P, Lopez-Giacoman S, Samoni S, de Cal M, Corradi V, Virzi GM, De Rosa S, Mucino Bermejo MJ, Estremadoyro C, Villa G, Zaragoza JJ, Caprara C, Brocca A, Birk HW, Walmrath HD, Seeger W, Nalesso F, Zanella M, Brendolan A, Giavarina D, Salvador L, Bellomo R, Rosner MH, Kellum JA, Ronco C. Preoperative Renal Functional Reserve Predicts Risk of Acute Kidney Injury After Cardiac Operation. Ann Thorac Surg. 2018 Apr;105(4):1094-1101. doi: 10.1016/j.athoracsur.2017.12.034. Epub 2018 Jan 31.
PubMed 29382510Sharma A, Zaragoza JJ, Villa G, Ribeiro LC, Lu R, Sartori M, Faggiana E, de Cal M, Virzi GM, Corradi V, Brocca A, Husain-Syed F, Brendolan A, Ronco C. Optimizing a kidney stress test to evaluate renal functional reserve. Clin Nephrol. 2016 Jul;86(7):18-26. doi: 10.5414/CN108497.
PubMed 27285313Ronco C, Kellum JA, Haase M. Subclinical AKI is still AKI. Crit Care. 2012 Jun 21;16(3):313. doi: 10.1186/cc11240.
PubMed 22721504Husain-Syed F, Ferrari F, Sharma A, Hinna Danesi T, Bezerra P, Lopez-Giacoman S, Samoni S, de Cal M, Corradi V, Virzi GM, De Rosa S, Mucino Bermejo MJ, Estremadoyro C, Villa G, Zaragoza JJ, Caprara C, Brocca A, Birk HW, Walmrath HD, Seeger W, Nalesso F, Zanella M, Brendolan A, Giavarina D, Salvador L, Bellomo R, Rosner MH, Kellum JA, Ronco C. Persistent decrease of renal functional reserve in patients after cardiac surgery-associated acute kidney injury despite clinical recovery. Nephrol Dial Transplant. 2019 Feb 1;34(2):308-317. doi: 10.1093/ndt/gfy227.
PubMed 30053231
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Renal Functional Reserve to Predict Risk of Acute Kidney Injury After Cardiac Surgery: The IRRIV Task Force and Collaborators for the Prevention of Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT03457987
- Acronym / sponsor ID
- AZ 216/17
- Conditions
- Acute Kidney Injury
- Keywords
- protein load, cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Shanghai Jiao Tong University School of Medicine, Robert Bosch Medical Center, Ospedale San Bortolo di Vicenza, Azienda Ospedaliero Universitaria Maggiore della Carita, Charite University, Berlin, Germany
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 21 Jan 2023 (actual)
- First posted
- 8 Mar 2018 (actual)
- 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.
The investigators seek to determine whether a reduced preoperative renal functional reserve predicts postoperative acute kidney injury in patients with normal estimated glomerular filtration rates undergoing elective cardiac surgery.
Detailed description
Although acute kidney injury (AKI) frequently complicates cardiac surgery, methods to determine AKI risk in patients without underlying kidney disease are lacking. Renal functional reserve (RFR) can be used to measure the capacity of the kidney to increase glomerular filtration rate under conditions of physiological stress and may serve as a functional marker that assesses susceptibility to injury.
The investigators seek to determine whether a reduced preoperative RFR predicts postoperative AKI in patients with normal estimated glomerular filtration rates undergoing elective cardiac surgery. All centres will measure RFR with creatinine clearance, except University Hospital Giessen where in addition iohexol plasma-clearance will be used.
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
- Adults undergoing elective cardiac surgery (with or without cardiopulmonary bypass) with an estimated GFR ≥60 ml/min/1.73 m2 (CKD-Epidemiology Collaboration equation)
Key inclusion criteria (4 listed)
- Subjects older than 18 years
- Subjects undergoing elective cardiac surgery (with or without cardiopulmonary bypass)
- Subjects with an estimated GFR ≥60 ml/min/1.73 m2 (CKD-Epidemiology Collaboration equation)
- Subjects who signed informed consent forms
Key exclusion criteria (22 listed)
- Preexisting acute kidney injury (as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days)
- Chronic kidney disease ≥ stage III (KDIGO)
- Subjects undergoing transcatheter aortic valve implantation (TAVI)
- Pregnancy
- Solitary kidney
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
Whether a reduced preoperative RFR ≤15 ml/min/1.73 m2 increased the odds ratio for postoperative acute kidney injury in patients undergoing elective cardiac surgery.
Time frame: Preoperative
Renal functional reserve
9 secondary outcomes
determine preoperative RFR accuracy based on receiver operating characteristic curve curve to predict acute kidney injury.
Time frame: Preoperative
To analyze an acute kidney injury risk prediction model based on clinical covariates.
Time frame: Preoperative
Mortality at 30 and 90 days
Time frame: 30 and 90 days after surgery
Length of stay in intensive care unit and hospital.
Time frame: Postoperative
Use and duration of renal replacement therapy during hospital stay.
Time frame: Postoperative
Renal replacement therapy dependence at days 30 and 90.
Time frame: 30 and 90 days after surgery
To evaluate renal function at three months after surgery.
Time frame: 3 months after surgery
To evaluate whether preoperative RFR is correlated to renal function at three months after surgery.
Time frame: Preoperative
To evaluate whether chronic kidney disease is associated to preoperative RFR.
Time frame: Preoperative
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 25 Jan 2023.
- Results publication: PubMed 29382510Husain-Syed F, Ferrari F, Sharma A, Danesi TH, Bezerra P, Lopez-Giacoman S, Samoni S, de Cal M, Corradi V, Virzi GM, De Rosa S, Mucino Bermejo MJ, Estremadoyro C, Villa G, Zaragoza JJ, Caprara C, Brocca A, Birk HW, Walmrath HD, Seeger W, Nalesso F, Zanella M, Brendolan A, Giavarina D, Salvador L, Bellomo R, Rosner MH, Kellum JA, Ronco C. Preoperative Renal Functional Reserve Predicts Risk of Acute Kidney Injury After Cardiac Operation. Ann Thorac Surg. 2018 Apr;105(4):1094-1101. doi: 10.1016/j.athoracsur.2017.12.034. Epub 2018 Jan 31.
- Results publication: PubMed 27285313Sharma A, Zaragoza JJ, Villa G, Ribeiro LC, Lu R, Sartori M, Faggiana E, de Cal M, Virzi GM, Corradi V, Brocca A, Husain-Syed F, Brendolan A, Ronco C. Optimizing a kidney stress test to evaluate renal functional reserve. Clin Nephrol. 2016 Jul;86(7):18-26. doi: 10.5414/CN108497.
- Results publication: PubMed 22721504Ronco C, Kellum JA, Haase M. Subclinical AKI is still AKI. Crit Care. 2012 Jun 21;16(3):313. doi: 10.1186/cc11240.
- Results publication: PubMed 30053231Husain-Syed F, Ferrari F, Sharma A, Hinna Danesi T, Bezerra P, Lopez-Giacoman S, Samoni S, de Cal M, Corradi V, Virzi GM, De Rosa S, Mucino Bermejo MJ, Estremadoyro C, Villa G, Zaragoza JJ, Caprara C, Brocca A, Birk HW, Walmrath HD, Seeger W, Nalesso F, Zanella M, Brendolan A, Giavarina D, Salvador L, Bellomo R, Rosner MH, Kellum JA, Ronco C. Persistent decrease of renal functional reserve in patients after cardiac surgery-associated acute kidney injury despite clinical recovery. Nephrol Dial Transplant. 2019 Feb 1;34(2):308-317. doi: 10.1093/ndt/gfy227.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
Claudio Ronco, MD study director
San Bortolo Hospital, Vicenza, Italy
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 University of Giessen at 1 site in Germany.
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 4 inclusion and 22 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 25 Jan 2023. 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 Germany. 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?
Whether a reduced preoperative RFR ≤15 ml/min/1.73 m2 increased the odds ratio for postoperative acute kidney injury in patients undergoing elective cardiac surgery. (time frame: Preoperative). 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 NCT03457987, which also lists 4 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 25 Jan 2023.