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Noninvasive Measurements of Renal Perfusion During Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT03335865
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
University of Utah

Brief Summary:
The purpose of this study is to assess the feasibility of measuring urine oxygen tension in cardiac surgery patient and the ability of peri-operative urine oxygen measurements to predict post-operative acute kidney injury. The hypothesis is that a small oxymeter placed in a urinary catheter will provide reliable measurement of urine oxygenation and that these measurements will predict post-operative acute kidney injury in cardiac surgery patients.

Condition or disease
Acute Kidney Injury

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Measurements of Renal Perfusion During Cardiac Surgery
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery




Primary Outcome Measures :
  1. Acute Kidney Injury, change in creatinine [ Time Frame: Creatinine is assessed as standard of care pre-operatively while in hospital (baseline) and every morning starting from the first day post-operative to discharge, an average of 5 days post-operative ]
    Defined as a rise in creatinine of at least .3 mg/dl or more in 48 hours or a rise of at least 1.5 times baseline


Secondary Outcome Measures :
  1. urine flow rate [ Time Frame: recorded continuously through out the entire operative period, before, during, and after CPB, into the intensive care unit, and up to 48 hrs post-operatively or until the urinary catheter is removed ]
    Urine flow in ml/hour

  2. Acute kidney injury biomarkers TIMP-2 and IGFBP7 [ Time Frame: pre-operatively, every 30 minutes intra-operatively, 4, 12, and 24 hours post-operative ]
    These biomarkers predict AKI in patients in the ICU and undergoing cardiac surgery.

  3. Vital signs [ Time Frame: highest, lowest, and mean intra-operative blood pressure and highest, lowest, and mean blood pressure while in the ICU for up to 48 hours ]
    Blood pressure

  4. Vital signs [ Time Frame: highest, lowest, and mean intra-operative heart rate and highest, lowest, and mean heart rate while in the ICU for up to 48 hours ]
    heart rate

  5. Vital signs [ Time Frame: highest, lowest, and mean intra-operative pulmonary artery pressure and highest, lowest, and mean pulmonary artery pressure pressure while in the ICU for up to 48 hours ]
    pulmonary artery pressure

  6. Vital signs [ Time Frame: highest, lowest, and mean intra-operative central venous pressure and highest, lowest, and mean central venous pressure while in the ICU for up to 48 hours ]
    central venous pressure

  7. Vital signs [ Time Frame: highest, lowest, and mean intra-operative temperature and highest, lowest, and mean blood pressure while in the ICU for up to 48 hours ]
    temperature

  8. Vital signs [ Time Frame: highest, lowest, and mean intra-operative central venous oxygenation and highest, lowest, and mean central venous oxygenation while in the ICU for up to 48 hours ]
    central venous oxygenation

  9. Vital signs [ Time Frame: Intra-operative or within the first 48 hours post-operative ]
    atrial or ventricular arrhythmia that requires treatment

  10. Cerebral oximetry [ Time Frame: recorded continuously intra-operatively ]
    Tissue oximetry of the cerebral cortex

  11. vasoactive medication doses [ Time Frame: recorded continuously intra-operatively and recorded continuously in ICU ]
    Epinephrine, vasopressin, norepinephrine, dobutamine, dopamine, and milrinone


Biospecimen Retention:   Samples Without DNA
1-2 ml of urine will be collected every 30 minutes while in the operating room, then at 4 hours and 24 hours after CBP. These samples will be labeled by study number and then stored for later biomarker analysis.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Elective or semi-elective/urgent Cardiac surgery patients aged 18 and older in whom CPB is a planned part of the procedure and a urinary catheter is planned during the surgery will be enrolled. Patients with contra-indications to urinary catheter or pre-operative dialysis dependent end stage renal disease, and emergency cases will be excluded.
Criteria

Inclusion Criteria:

  • Elective or semi-elective/urgent Cardiac surgery patients in whom CPB is a planned part of the procedure.
  • 18 years or older
  • Urinary catheter is planned during the surgery

Exclusion Criteria:

  • Contra-indications to urinary catheter
  • Pre-operative dialysis dependent end stage renal disease
  • Emergency cases

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 ClinicalTrials.gov identifier (NCT number): NCT03335865


Contacts
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Contact: Natalie Silverton, MD 8012051046 natalie.silverton@hsc.utah.edu
Contact: Ami Stuart, PhD 8017934800 ami.stuart@hsc.utah.edu

Locations
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United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Ami Stuart, PhD    801-793-4800    ami.stuart@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Natalie Silverton, MD University of Utah

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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT03335865     History of Changes
Other Study ID Numbers: IRB104747
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

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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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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases