Adenosine as an Adjunct to Blood Cardioplegia

NCT ID: NCT02681913

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-12-31

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.

Detailed Description

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 whether the addition of adenosine to standard intermittent warm blood cardioplegia reduces the 6-hours post-operative cardiac troponin T (cTnT) in patients scheduled for minimally invasive, port access operations (mitral valve surgery).

Conditions

Pathological Processes; Cardiomyopathies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

standard cardioplegia

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

adenosine enriched cardioplegia

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

Group Type: EXPERIMENTAL

Adenosine

Intervention Type: DRUG

This group receives intermittent warm blood cardioplegia enriched with adenosine

Interventions

Adenosine

This group receives intermittent warm blood cardioplegia enriched with adenosine

Intervention Type: DRUG

Other Intervention Names

Adenocor

Eligibility Criteria

Inclusion Criteria

• Elective cardiac surgical patients

• minimally invasive, port access surgery (mitral valve surgery)

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amphia Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Engelhart

PharmD, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Engelhart, PharmD

Role: PRINCIPAL_INVESTIGATOR

Amphia Hospital

Locations

Amphia Hospital

Breda, North Brabant, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Jeffrey Engelhart, PharmD

Role: CONTACT

JEngelhart@amphia.nl

0031765954391

Thierry Scohy, MD

Role: CONTACT

TScohy@amphia.nl

003176595570

Facility Contacts

Jeffrey Engelhart, PharmD

Role: primary

jengelhart@amphia.nl

0031765954391

Thierry Scohy, MD

Role: backup

tscohy@amphia.nl

0031765955570

References

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.

Reference Type: BACKGROUND

PMID: 22108937 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9852907 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10585118 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10698387 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10235522 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22795715 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22964356 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19683936 (View on PubMed)

Other Identifiers

2015-001923-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1437

Identifier Type: -

Identifier Source: org_study_id