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Preoperative Prediction of Acute Kidney Injury After Cardiac Surgery

Use of Preoperative Renal Functional Reserve to Predict Risk of Acute Kidney Injury After Cardiac Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03092947
Acronym
RFR
Enrollment
110
Registered
2017-03-28
Start date
2014-11-01
Completion date
2016-02-28
Last updated
2017-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Brief summary

Although acute kidney injury (AKI) frequently complicates cardiac surgery, methods to determine AKI risk are lacking. Renal functional reserve (RFR), the capacity of the intact nephron mass to increase glomerular filtration rate (GFR), represents maximal filtration capacity. We hypothesized that preoperative RFR would predict postoperative AKI.

Detailed description

Acute kidney injury (AKI) is a frequent complication in patients undergoing cardiac surgery with an estimated prevalence of 36%. However, clinicians have limited tools to preoperatively identify patients at risk for AKI and/or progression to chronic kidney disease, particularly in patients with normal resting glomerular filtration rate (rGFR). Renal functional reserve (RFR) describes the capacity of the intact nephron mass to increase GFR from baseline in response to stimuli (e.g., protein load). We hypothesized that the presence or absence of RFR could separate patients at risk for developing AKI from patients with better-preserved renal function and a more favorable short- and long-term prognosis despite identical rGFR. The aim of this study is to examine whether preoperative assessment of RFR is able to predict risk for AKI after cardiac surgery.

Interventions

OTHERNo intervention

Sponsors

University of Giessen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Subjects older than 18 years 2. Subjects undergoing elective cardiac surgery 3. Subjects who signed informed consent forms

Exclusion criteria

1. Pregnancy 2. Chronic kidney disease ≥ stage III 3. Solitary kidney 4. Diabetes mellitus type 1 5. Recent cardiac arrest 6. Liver failure or cirrhosis 7. Total parenteral nutrition 8. Hemoglobin \<11 g/dl 9. Sepsis 10. History of malabsorption, chronic inflammatory bowel disease, short bowel, or pancreatic insufficiency 11. Transplant donor or recipient 12. Active autoimmune disease with renal involvement 13. Rhabdomyolysis 14. Prostate hypertrophy with International Prostate Symptom Score ≥20 15. Neoplasm Withdrawal criteria: All patients included in the study were to be followed up until the scheduled end of the study. Data collection could be terminated prior to the scheduled time only under the following conditions: * General criteria 1. A patient or his/her legal representative may refuse further participation in the study at any time (withdrawal of consent), 2. The investigator may withdraw a patient from the participation in the study at any time for the following reasons: * a severe protocol violation, * the development of incidents/near-incidents/other severe clinical complications related to the study protocol * Criteria related to the study 1. Subjects who could not stop taking angiotensin-converting enzyme inhibitors and/or angiotensin II receptor blockers a minimum of 48 hours before the protein load. 2. Subjects who received non-steroidal anti-inflammatory drugs within the 48 hours before the protein load. 3. Subjects who received intravenous radiocontrast agents within the 72 hours before the protein load.

Design outcomes

Primary

MeasureTime frame
The predictive value of RFR for AKI in patients undergoing elective cardiac surgery1 day before cardiac surgery

Secondary

MeasureTime frame
Whether the occurrence of AKI (as defined by Kidney Disease Improving Global Outcomes criteria) impacts RFR three months after surgery in patients without ongoing reduced function defined by resting GFR3 months after cardiac surgery
Whether urinary [TIMP-2][IGFBP7] predicts loss of RFR3 months after cardiac surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026