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Clinical Trials/NCT03457987
NCT03457987
Completed
Not Applicable

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

University of Giessen1 site in 1 country30 target enrollmentMarch 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
University of Giessen
Enrollment
30
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
3 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
January 21, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Faeq Husain-Syed

Senior Physician

University of Giessen

Eligibility Criteria

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)
  • Solitary kidney
  • Diabetes mellitus type 1
  • Recent cardiac arrest (within last 3 months)
  • Liver failure or cirrhosis
  • Total parenteral nutrition
  • Hemoglobin \<11 g/dl
  • History of malabsorption, chronic inflammatory bowel disease, short bowel, or pancreatic insufficiency

Outcomes

Primary Outcomes

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

  • determine preoperative RFR accuracy based on receiver operating characteristic curve curve to predict acute kidney injury.(Preoperative)
  • Mortality at 30 and 90 days(30 and 90 days after surgery)
  • To evaluate renal function at three months after surgery.(3 months after surgery)
  • Use and duration of renal replacement therapy during hospital stay.(Postoperative)
  • Renal replacement therapy dependence at days 30 and 90.(30 and 90 days after surgery)
  • To evaluate whether chronic kidney disease is associated to preoperative RFR.(Preoperative)
  • To analyze an acute kidney injury risk prediction model based on clinical covariates.(Preoperative)
  • Length of stay in intensive care unit and hospital.(Postoperative)
  • To evaluate whether preoperative RFR is correlated to renal function at three months after surgery.(Preoperative)

Study Sites (1)

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