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Platelet and Tissue cAMP: Novel Biomarkers of Milrinone Efficacy in Children

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.
 
ClinicalTrials.gov Identifier: NCT02728128
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
The purpose of this study is to identify if circulating platelet cyclic adenosine monophosphate (cAMP) levels can be used as a biomarker of milrinone efficacy in children following cardiac surgery or undergoing heart transplant.

Condition or disease
Pediatrics Heart Failure Congenital Heart Disease Therapeutics

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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelet and Tissue cAMP: Novel Biomarkers of Milrinone Efficacy in Children
Study Start Date : August 2016
Actual Primary Completion Date : August 17, 2017
Actual Study Completion Date : August 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort
Low cardiac output syndrome
Patients who experience low cardiac output syndrome
No low cardiac output syndrome
Group that does not experience low cardiac output syndrome.



Primary Outcome Measures :
  1. Time to the development of low cardiac output syndrome [ Time Frame: Within 36 hours following cardiac surgery ]
    Criteria for low cardiac output


Biospecimen Retention:   Samples Without DNA
Plasma and urine samples will be retained for future studies once initial analyses have been performed.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children undergoing cardiac surgery with the use of cardiopulmonary bypass
Criteria

Inclusion Criteria:

  • Children aged birth to 18 year of age
  • Surgical complexity STAT score > 3
  • Use of cardiopulmonary bypass for cardiac surgery
  • Use of milrinone intra-operatively and post-operatively

Exclusion Criteria:

  • Patients on milrinone therapy prior to surgery
  • Gestational age less than 34 weeks at the time of surgery
  • Weight less than 2500 grams at the time of surgery
  • Abnormal renal function prior to cardiac surgery. Abnormal renal function is defined as a serum creatinine > 0.3mg/dL above baseline (lowest value in the preceding 3 months prior to surgery) compared to the level obtained immediately prior to cardiac surgery.

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): NCT02728128


Locations
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United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Katja M Gist, DO, MSCS University of Colorado, Denver
Publications:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02728128    
Other Study ID Numbers: 15-2239
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Colorado, Denver:
Milrinone
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases