NCT02681913

Brief Summary

Myocardial protection is a major issue in cardiac surgery, since inadequate protection increases the risk of postoperative cardiac dysfunction. The main principle of myocardial protection in cardiac surgery is to preserve myocardial function by preventing ischemia with blood cardioplegia . Previous studies have shown that adenosine as an adjunct to blood cardioplegia can be safely used in cardiac surgery. In the Amphia Hospital, adenosine is already used as standard care as an initial cardioplegic bolus in minimally invasive port access operations. Whether, adenosine as an adjunct to intermittent warm blood cardioplegia, has an added value remains unclear. Therefore the investigators would like to investigate the effect of the addition of adenosine to standard intermittent warm blood cardioplegia in patients scheduled for minimally invasive, port access operations (mitral valve surgery). Half of the participants will receive standard intermittent warm blood cardioplegia, while the other half will receive intermittent warm blood cardioplegia enriched with adenosine.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

2.4 years

First QC Date

February 3, 2016

Last Update Submit

April 19, 2017

Conditions

Pathological ProcessesCardiomyopathies

Keywords

CardioplegiaCardiac SurgeryAdenosineTherapeutic UsesIntermittent warm blood cardioplegiaMinimally Invasive Surgeryminimally invasive mitral valve plasty (mini-MPL)minimally invasive mitral valve replacement (mini-MVR)

Outcome Measures

Primary Outcomes (1)

  • 6-hour cardiac Troponin T (cTnT) release

    The primary end point is 6-hour cTnT release

    6 hours post-operative

Secondary Outcomes (12)

  • 18-hour cardiac Troponin T (cTnT) area under the curve (AUC) release

    cardiac Troponin T (cTnT) AUC will be assessed at different time points, the latest up to 18 hours after ICU arrival

  • Incidence of myocardial injury on 12-lead ECG

    participants will be followed for the duration of ICU stay, an expected average of 2 days

  • Vasoactive-inotropic score

    participants will be followed for the duration of ICU stay, an expected average of 2 days

  • Vasoconstrictor usage

    participants will be followed for the duration of ICU stay, an expected average of 2 days

  • Incidence of new onset Atrial fibrillation (AF)

    participants will be followed for the duration of ICU stay, an expected average of 2 days

  • +7 more secondary outcomes

Study Arms (2)

standard cardioplegia

NO INTERVENTION

Delivery of cardioplegic solutions will be according to the standard protocol (Amphia hospital, Breda, the Netherlands). Oxygenated blood and cardioplegic maintenance solution is delivered in a 20:1 ratio. Cardioplegic solutions will be administered at 20-minutes intervals. The flow of the cardioplegia must be at 300 ml/min, the duration is approximately 1 minute. The cardioplegic maintenance solution consists of a 500 ml normal saline (0.9% NaCl) infusion bag. Potassiumchloride (20 mmol) and magnesiumsulphate (1000 mg) is added according to standard protocol. This arms receives standard intermittent 20:1 diluted warm blood cardioplegic solution. Intervention: n/a

adenosine enriched cardioplegia

EXPERIMENTAL

Delivery of cardioplegic solutions will be according to the standard protocol (Amphia hospital, Breda, the Netherlands). Oxygenated blood and cardioplegic maintenance solution is delivered in a 20:1 ratio. Cardioplegic solutions will be administered at 20-minutes intervals. The flow of the cardioplegia must be at 300 ml/min, the duration is approximately 1 minute. The cardioplegic maintenance solution consists of a 1000 mg = 500 ml adenosine infusion bag (2 mg/ml). Potassiumchloride (20 mmol) and magnesiumsulphate (1000 mg) is added according to standard protocol. This arms receives adenosine enriched, intermittent 20:1 diluted warm blood cardioplegic solution. Intervention: Drug: Adenosine

Drug: Adenosine

Interventions

AdenosineDRUG

This group receives intermittent warm blood cardioplegia enriched with adenosine

Also known as: Adenocor
adenosine enriched cardioplegia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective cardiac surgical patients
  • minimally invasive, port access surgery (mitral valve surgery)

You may not qualify if:

  • All non-minimally invasive, port access surgery
  • Theophylline or dipyridamole use up to 24 hours prior to surgery
  • Products that contain caffeine of theobromine up to 12 hours prior to surgery (coffee, chocolate, energizing drinks (e.g. Red Bull), tea, soda (coke), etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amphia Hospital

Breda, North Brabant, 4818CK, Netherlands

RECRUITING

Related Publications (8)

  • Ahlsson A, Sobrosa C, Kaijser L, Jansson E, Bomfim V. Adenosine in cold blood cardioplegia--a placebo-controlled study. Interact Cardiovasc Thorac Surg. 2012 Jan;14(1):48-55. doi: 10.1093/icvts/ivr027. Epub 2011 Nov 15.

    PMID: 22108937BACKGROUND

  • Cohen G, Feder-Elituv R, Iazetta J, Bunting P, Mallidi H, Bozinovski J, Deemar C, Christakis GT, Cohen EA, Wong BI, McLean RD, Myers M, Morgan CD, Mazer CD, Smith TS, Goldman BS, Naylor CD, Fremes SE. Phase 2 studies of adenosine cardioplegia. Circulation. 1998 Nov 10;98(19 Suppl):II225-33.

    PMID: 9852907BACKGROUND

  • Cohen G, Borger MA, Weisel RD, Rao V. Intraoperative myocardial protection: current trends and future perspectives. Ann Thorac Surg. 1999 Nov;68(5):1995-2001. doi: 10.1016/s0003-4975(99)01026-7.

    PMID: 10585118BACKGROUND

  • Chauhan S, Wasir HS, Bhan A, Rao BH, Saxena N, Venugopal P. Adenosine for cardioplegic induction: a comparison with St Thomas solution. J Cardiothorac Vasc Anesth. 2000 Feb;14(1):21-4. doi: 10.1016/s1053-0770(00)90050-8.

    PMID: 10698387BACKGROUND

  • Mentzer RM Jr, Birjiniuk V, Khuri S, Lowe JE, Rahko PS, Weisel RD, Wellons HA, Barker ML, Lasley RD. Adenosine myocardial protection: preliminary results of a phase II clinical trial. Ann Surg. 1999 May;229(5):643-9; discussion 649-50. doi: 10.1097/00000658-199905000-00006.

    PMID: 10235522BACKGROUND

  • Onorati F, Santini F, Dandale R, Ucci G, Pechlivanidis K, Menon T, Chiominto B, Mazzucco A, Faggian G. "Polarizing" microplegia improves cardiac cycle efficiency after CABG for unstable angina. Int J Cardiol. 2013 Sep 10;167(6):2739-46. doi: 10.1016/j.ijcard.2012.06.099. Epub 2012 Jul 12.

    PMID: 22795715BACKGROUND

  • Jakobsen O, Naesheim T, Aas KN, Sorlie D, Steensrud T. Adenosine instead of supranormal potassium in cardioplegia: it is safe, efficient, and reduces the incidence of postoperative atrial fibrillation. A randomized clinical trial. J Thorac Cardiovasc Surg. 2013 Mar;145(3):812-8. doi: 10.1016/j.jtcvs.2012.07.058. Epub 2012 Sep 7.

    PMID: 22964356BACKGROUND

  • Liu R, Xing J, Miao N, Li W, Liu W, Lai YQ, Luo Y, Ji B. The myocardial protective effect of adenosine as an adjunct to intermittent blood cardioplegia during open heart surgery. Eur J Cardiothorac Surg. 2009 Dec;36(6):1018-23. doi: 10.1016/j.ejcts.2009.06.033. Epub 2009 Aug 15.

    PMID: 19683936BACKGROUND

MeSH Terms

Conditions

Pathologic ProcessesCardiomyopathies

Interventions

Adenosine

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Purine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Jeffrey Engelhart, PharmD

    Amphia Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Engelhart, PharmD

CONTACT

0031765954391JEngelhart@amphia.nl

Thierry Scohy, MD

CONTACT

003176595570TScohy@amphia.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PharmD, MSc

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 15, 2016

Study Start

February 1, 2016

Primary Completion

July 1, 2018

Study Completion

December 1, 2018

Last Updated

April 20, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)