Acute Kidney Injury After Cardiac Surgery

January 21, 2023 updated by: Faeq Husain-Syed, University of Giessen

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hessen
      • Gießen, Hessen, Germany, 35392
        • University Clinic Giessen and Marburg - Campus Giessen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Preoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
determine preoperative RFR accuracy based on receiver operating characteristic curve curve to predict acute kidney injury.
Time Frame: Preoperative
Renal functional reserve
Preoperative
To analyze an acute kidney injury risk prediction model based on clinical covariates.
Time Frame: Preoperative
Renal functional reserve
Preoperative
Mortality at 30 and 90 days
Time Frame: 30 and 90 days after surgery
Mortality
30 and 90 days after surgery
Length of stay in intensive care unit and hospital.
Time Frame: Postoperative
Hospital stay
Postoperative
Use and duration of renal replacement therapy during hospital stay.
Time Frame: Postoperative
Renal replacement therapy
Postoperative
Renal replacement therapy dependence at days 30 and 90.
Time Frame: 30 and 90 days after surgery
Renal replacement therapy
30 and 90 days after surgery
To evaluate renal function at three months after surgery.
Time Frame: 3 months after surgery
Estimated glomerular filtration rate
3 months after surgery
To evaluate whether preoperative RFR is correlated to renal function at three months after surgery.
Time Frame: Preoperative
Renal functional reserve
Preoperative
To evaluate whether chronic kidney disease is associated to preoperative RFR.
Time Frame: Preoperative
Renal functional reserve
Preoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

June 23, 2022

Study Completion (Actual)

January 21, 2023

Study Registration Dates

First Submitted

March 1, 2018

First Submitted That Met QC Criteria

March 6, 2018

First Posted (Actual)

March 8, 2018

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 21, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • AZ 216/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Time Frame

Starting 6 months after publication.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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