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Completed

NCT Number: NCT03457987

Acute Kidney Injury After Cardiac Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Clinic Giessen and Marburg - Campus Giessen

Giessen, Hesse, 35392, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Primary outcomes

  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.

    Time frame: Preoperative

    Renal functional reserve

Secondary outcomes

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

    Time frame: Preoperative

    Renal functional reserve

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

    Time frame: Preoperative

    Renal functional reserve

  3. Mortality at 30 and 90 days

    Time frame: 30 and 90 days after surgery

    Mortality

  4. Length of stay in intensive care unit and hospital.

    Time frame: Postoperative

    Hospital stay

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

    Time frame: Postoperative

    Renal replacement therapy

  6. Renal replacement therapy dependence at days 30 and 90.

    Time frame: 30 and 90 days after surgery

    Renal replacement therapy

  7. To evaluate renal function at three months after surgery.

    Time frame: 3 months after surgery

    Estimated glomerular filtration rate

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

    Time frame: Preoperative

    Renal functional reserve

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

    Time frame: Preoperative

    Renal functional reserve

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Collaborators

  • Azienda Ospedaliero Universitaria Maggiore della Carita
  • Charite University, Berlin, Germany
  • Guy's and St Thomas' NHS Foundation Trust
  • Ospedale San Bortolo di Vicenza
  • Robert Bosch Medical Center
  • Shanghai Jiao Tong University School of Medicine

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Mar 8, 2018
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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