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Trial record 24 of 52 for:    TIMP2

Preoperative Prediction of Acute Kidney Injury After Cardiac Surgery (RFR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03092947
Recruitment Status : Completed
First Posted : March 28, 2017
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
Faeq Husain, University of Giessen

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.

Condition or disease Intervention/treatment
Acute Kidney Injury Other: No intervention

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.

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Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Preoperative Renal Functional Reserve to Predict Risk of Acute Kidney Injury After Cardiac Surgery
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : October 31, 2015
Actual Study Completion Date : February 28, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Primary Outcome Measures :
  1. The predictive value of RFR for AKI in patients undergoing elective cardiac surgery [ Time Frame: 1 day before cardiac surgery ]

Secondary Outcome Measures :
  1. 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 ]
  2. Whether urinary [TIMP-2][IGFBP7] predicts loss of RFR [ Time Frame: 3 months after cardiac surgery ]

Biospecimen Retention:   Samples With DNA
Collection of only residual material (blood, urine) for International Renal Research Institute

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients undergoing elective cardiac surgery

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03092947

Sponsors and Collaborators
University of Giessen
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Study Director: Claudio Ronco, MD International Renal Research Institute of Vicenza

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Faeq Husain, Senior Physician, University of Giessen Identifier: NCT03092947     History of Changes
Other Study ID Numbers: n63/14
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases