NCT02728128

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2017

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 8, 2016

Last Update Submit

March 2, 2020

Conditions

PediatricsHeart FailureCongenital Heart DiseaseTherapeutics

Keywords

Milrinone

Outcome Measures

Primary Outcomes (1)

  • Time to the development of low cardiac output syndrome

    Criteria for low cardiac output

    Within 36 hours following cardiac surgery

Study Arms (2)

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.

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children undergoing cardiac surgery with the use of cardiopulmonary bypass

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (12)

  • DiBianco R, Shabetai R, Kostuk W, Moran J, Schlant RC, Wright R. A comparison of oral milrinone, digoxin, and their combination in the treatment of patients with chronic heart failure. N Engl J Med. 1989 Mar 16;320(11):677-83. doi: 10.1056/NEJM198903163201101.

    PMID: 2646536BACKGROUND

  • Ewy GA. Inotropic infusions for chronic congestive heart failure: medical miracles or misguided medicinals? J Am Coll Cardiol. 1999 Feb;33(2):572-5. doi: 10.1016/s0735-1097(98)00596-8. No abstract available.

    PMID: 9973041BACKGROUND

  • Hauptman PJ, Mikolajczak P, George A, Mohr CJ, Hoover R, Swindle J, Schnitzler MA. Chronic inotropic therapy in end-stage heart failure. Am Heart J. 2006 Dec;152(6):1096.e1-8. doi: 10.1016/j.ahj.2006.08.003.

    PMID: 17161059BACKGROUND

  • Felker GM, O'Connor CM. Inotropic therapy for heart failure: an evidence-based approach. Am Heart J. 2001 Sep;142(3):393-401. doi: 10.1067/mhj.2001.117606.

    PMID: 11526351BACKGROUND

  • Nony P, Boissel JP, Lievre M, Leizorovicz A, Haugh MC, Fareh S, de Breyne B. Evaluation of the effect of phosphodiesterase inhibitors on mortality in chronic heart failure patients. A meta-analysis. Eur J Clin Pharmacol. 1994;46(3):191-6. doi: 10.1007/BF00192547.

    PMID: 8070498BACKGROUND

  • Packer M, Carver JR, Rodeheffer RJ, Ivanhoe RJ, DiBianco R, Zeldis SM, Hendrix GH, Bommer WJ, Elkayam U, Kukin ML, et al. Effect of oral milrinone on mortality in severe chronic heart failure. The PROMISE Study Research Group. N Engl J Med. 1991 Nov 21;325(21):1468-75. doi: 10.1056/NEJM199111213252103.

    PMID: 1944425BACKGROUND

  • Packer M, Medina N, Yushak M. Hemodynamic and clinical limitations of long-term inotropic therapy with amrinone in patients with severe chronic heart failure. Circulation. 1984 Dec;70(6):1038-47. doi: 10.1161/01.cir.70.6.1038.

    PMID: 6388899BACKGROUND

  • Price JF, Towbin JA, Dreyer WJ, Moffett BS, Kertesz NJ, Clunie SK, Denfield SW. Outpatient continuous parenteral inotropic therapy as bridge to transplantation in children with advanced heart failure. J Card Fail. 2006 Mar;12(2):139-43. doi: 10.1016/j.cardfail.2005.11.001.

    PMID: 16520263BACKGROUND

  • Birnbaum BF, Simpson KE, Boschert TA, Zheng J, Wallendorf MJ, Schechtman K, Canter CE. Intravenous home inotropic use is safe in pediatric patients awaiting transplantation. Circ Heart Fail. 2015 Jan;8(1):64-70. doi: 10.1161/CIRCHEARTFAILURE.114.001528. Epub 2014 Dec 3.

    PMID: 25472966BACKGROUND

  • Berg AM, Snell L, Mahle WT. Home inotropic therapy in children. J Heart Lung Transplant. 2007 May;26(5):453-7. doi: 10.1016/j.healun.2007.02.004.

    PMID: 17449413BACKGROUND

  • Hoffman TM, Wernovsky G, Atz AM, Bailey JM, Akbary A, Kocsis JF, Nelson DP, Chang AC, Kulik TJ, Spray TL, Wessel DL. Prophylactic intravenous use of milrinone after cardiac operation in pediatrics (PRIMACORP) study. Prophylactic Intravenous Use of Milrinone After Cardiac Operation in Pediatrics. Am Heart J. 2002 Jan;143(1):15-21. doi: 10.1067/mhj.2002.120305.

    PMID: 11773907BACKGROUND

  • Gist KM, Mizuno T, Goldstein SL, Vinks A. Retrospective Evaluation of Milrinone Pharmacokinetics in Children With Kidney Injury. Ther Drug Monit. 2015 Dec;37(6):792-6. doi: 10.1097/FTD.0000000000000214.

    PMID: 25860636BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and urine samples will be retained for future studies once initial analyses have been performed.

MeSH Terms

Conditions

Heart FailureHeart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Katja M Gist, DO, MSCS

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2016

First Posted

April 5, 2016

Study Start

August 1, 2016

Primary Completion

August 17, 2017

Study Completion

August 17, 2017

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)