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Effectiveness of NephroCheckTM Test to Predict Acute Kidney Injury Following Advanced Cardiac Replacement Therapies

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ClinicalTrials.gov Identifier: NCT02827448
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
The purpose of this study is to test how well the NephroCheckTM Test, a noninvasive laboratory test performed on urine, predicts loss of kidney function in patients that have had a heart transplant or a Left Ventricular Assist Device (LVAD) or Total Artificial Heart (TAH) implanted.

Condition or disease
Acute Kidney Injury Heart Failure

Detailed Description:

Current strategies for AKI detection rely primarily on elevations in serum creatinine in conjunction with diminished urine output. Unfortunately, deviations in these crude parameters of renal function are largely insensitive and late manifestations of AKI, where acute tubular necrosis has likely already transpired and therefore well beyond the phase where preventive measures may be instituted. Early phase biomarkers, insulin-like growth factor-binding protein 7 ("IGFBP7") and tissue inhibitor of metalloproteinases-2 ("TIMP-2") are critical mediators of G1 cell cycle arrest of renal tubular cells during the early phase of cellular injury, providing a potential therapeutic window to prevent permanent damage. To date, no study has evaluated the efficacy of these early phase renal biomarkers for detecting AKI in advanced heart failure patients undergoing cardiac replacement therapies.

Therefore, the aim of this prospective observational study will be to evaluate the effectiveness of the NephroCheckTM to predict AKI in patients undergoing transplant, LVAD implant, or TAH implant.


Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Urinary Cell Cycle Arrest Biomarkers as Early Predictors of Acute Kidney Injury Following Advanced Cardiac Replacement Therapies
Study Start Date : November 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : November 2018



Primary Outcome Measures :
  1. [TIMP-2]*[IGFBP7] measurement using NephroCheck following LVAD or TAH implantation [ Time Frame: 1 year ]
  2. Occurrence of AKI following LVAD or TAH implantation [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. [TIMP-2]*[IGFBP7] measurement using NephroCheck following cardiac transplantation [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that have had a heart transplant or LVAD implant.
Criteria

Inclusion Criteria:

  • Patients who will receive LVAD or heart transplantation

Exclusion Criteria:

  • Patients who are unable to give consent

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): NCT02827448


Contacts
Contact: Horacio Martinez, BS, CCRC 214-820-0338 Horacio.Martinez@BSWHealth.org
Contact: Carmen Bonilla, BSN, RN 214-818-2588 Carmen.Bonilla@BSWHealth.org

Locations
United States, Texas
Baylor Research Institute Recruiting
Dallas, Texas, United States, 75204
Contact: Horacio Martinez, BS, CCRC    214-820-0338    Horacio.Martinez@BSWHealth.org   
Contact: Carmen Bonilla, BSN, RN    214-818-2588    Carmen.Bonilla@BSWHealth.org   
Sponsors and Collaborators
Baylor Research Institute
Investigators
Principal Investigator: Susan Joseph, MD Baylor University Medical Center at Dallas

Publications:

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT02827448     History of Changes
Other Study ID Numbers: BRI - 015-179
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017

Keywords provided by Baylor Research Institute:
Left Ventricular Assist Device
Heart Transplantation
Perioperative
Acute Kidney Injury
Renal
Kidney
Total Artificial Heart

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