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Acute Kidney Injury After Cardiac Surgery

Sponsor
University of Giessen (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03457987
Collaborator
Guy's and St Thomas' NHS Foundation Trust (Other), Shanghai Jiao Tong University School of Medicine (Other), Robert Bosch Medical Center (Other), Ospedale San Bortolo di Vicenza (Other), Azienda Ospedaliero Universitaria Maggiore della Carita (Other), Charite University, Berlin, Germany (Other)
30
Enrollment
1
Location
55
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Mar 1, 2018
    Actual Primary Completion Date :
    Jun 23, 2022
    Anticipated Study Completion Date :
    Oct 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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. [Preoperative]

      Renal functional reserve

    Secondary Outcome Measures

    1. determine preoperative RFR accuracy based on receiver operating characteristic curve curve to predict acute kidney injury. [Preoperative]

      Renal functional reserve

    2. To analyze an acute kidney injury risk prediction model based on clinical covariates. [Preoperative]

      Renal functional reserve

    3. Mortality at 30 and 90 days [30 and 90 days after surgery]

      Mortality

    4. Length of stay in intensive care unit and hospital. [Postoperative]

      Hospital stay

    5. Use and duration of renal replacement therapy during hospital stay. [Postoperative]

      Renal replacement therapy

    6. Renal replacement therapy dependence at days 30 and 90. [30 and 90 days after surgery]

      Renal replacement therapy

    7. To evaluate renal function at three months after surgery. [3 months after surgery]

      Estimated glomerular filtration rate

    8. To evaluate whether preoperative RFR is correlated to renal function at three months after surgery. [Preoperative]

      Renal functional reserve

    9. To evaluate whether chronic kidney disease is associated to preoperative RFR. [Preoperative]

      Renal functional reserve

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Subjects older than 18 years

    2. Subjects undergoing elective cardiac surgery (with or without cardiopulmonary bypass)

    3. Subjects with an estimated GFR ≥60 ml/min/1.73 m2 (CKD-Epidemiology Collaboration equation)

    4. Subjects who signed informed consent forms

    Exclusion Criteria:

    1. Preexisting acute kidney injury (as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days)

    2. Chronic kidney disease ≥ stage III (KDIGO)

    3. Subjects undergoing transcatheter aortic valve implantation (TAVI)

    4. Pregnancy

    5. Solitary kidney

    6. Diabetes mellitus type 1

    7. Recent cardiac arrest (within last 3 months)

    8. Liver failure or cirrhosis

    9. Total parenteral nutrition

    10. Hemoglobin <11 g/dl

    11. Sepsis

    12. History of malabsorption, chronic inflammatory bowel disease, short bowel, or pancreatic insufficiency

    13. Transplant donor or recipient

    14. Active autoimmune disease with renal involvement

    15. Rhabdomyolysis

    16. Prostate hypertrophy with International Prostate Symptom Score ≥20

    17. Active neoplasm

    18. Decompensated heart failure / inability to pause angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers minimum 2 days before protein load

    19. Known iodine allergy (exclusion criteria only for those centres who use iohexol plasma clearance for determination of GFR)

    20. TSH <0.3 µU/l (exclusion criteria only for those centres who use iohexol)

    21. Subjects who received intravenous radiocontrast agents within the 72 hours before the protein load

    22. Subjects who received NSAIDs within 48 hours before the protein load

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Clinic Giessen and Marburg - Campus Giessen Gießen Hessen Germany 35392

    Sponsors and Collaborators

    • University of Giessen
    • 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

    Investigators

    • Study Director: Claudio Ronco, MD, San Bortolo Hospital, Vicenza, Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Faeq Husain-Syed, Senior Physician, University of Giessen
    ClinicalTrials.gov Identifier:
    NCT03457987
    Other Study ID Numbers:
    • AZ 216/17
    First Posted:
    Mar 8, 2018
    Last Update Posted:
    Jun 27, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Faeq Husain-Syed, Senior Physician, University of Giessen
    protein load
    cardiac surgery
    Additional relevant MeSH terms:
    Acute Kidney Injury
    Wounds and Injuries

    Study Results

    No Results Posted as of Jun 27, 2022