NCT Number: NCT03092947
Preoperative Prediction of Acute Kidney Injury After Cardiac Surgery
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.
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
About this study
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.
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
- Subjects who signed informed consent forms
Exclusion criteria
- Pregnancy
- Chronic kidney disease ≥ stage III
- Solitary kidney
- Diabetes mellitus type 1
- Recent cardiac arrest
- 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
- 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
- A patient or his/her legal representative may refuse further participation in the study at any time (withdrawal of consent),
- 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
- 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.
- Subjects who received non-steroidal anti-inflammatory drugs within the 48 hours before the protein load.
- Subjects who received intravenous radiocontrast agents within the 72 hours before the protein load.
Treatment and study plan
Primary outcomes
-
The predictive value of RFR for AKI in patients undergoing elective cardiac surgery
Time frame: 1 day before cardiac surgery
Secondary outcomes
-
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 GFR
Time frame: 3 months after cardiac surgery
-
Whether urinary [TIMP-2][IGFBP7] predicts loss of RFR
Time frame: 3 months after cardiac surgery
Sponsors and collaborators
Lead sponsor
University of Giessen
Other
Registry information
Official study title
Use of Preoperative Renal Functional Reserve to Predict Risk of Acute Kidney Injury After Cardiac Surgery
Acronym: RFR
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2016
- First posted
- Mar 28, 2017
- Registry last updated
- Mar 29, 2017
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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