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Trial record 9 of 1129 for:    adenosine

Adenosine as an Adjunct to Blood Cardioplegia

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ClinicalTrials.gov Identifier: NCT02681913
Recruitment Status : Unknown
Verified April 2017 by Jeffrey Engelhart, Amphia Hospital.
Recruitment status was:  Recruiting
First Posted : February 15, 2016
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Jeffrey Engelhart, Amphia Hospital

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.


Condition or disease Intervention/treatment Phase
Pathological Processes Cardiomyopathies Drug: Adenosine Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Adenosine on Myocardial Protection in Intermittent Warm Blood Cardioplegia: A Randomized Placebo-controlled Trial
Study Start Date : February 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

Arm Intervention/treatment
No Intervention: 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

Experimental: 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

Drug: Adenosine
This group receives intermittent warm blood cardioplegia enriched with adenosine
Other Name: Adenocor




Primary Outcome Measures :
  1. 6-hour cardiac Troponin T (cTnT) release [ Time Frame: 6 hours post-operative ]
    The primary end point is 6-hour cTnT release


Secondary Outcome Measures :
  1. 18-hour cardiac Troponin T (cTnT) area under the curve (AUC) release [ Time Frame: cardiac Troponin T (cTnT) AUC will be assessed at different time points, the latest up to 18 hours after ICU arrival ]
    18-hour postoperative AUC release of cardiac troponin T Routine blood samples pre-operatively from peripheral blood (T0); post-operatively, from peripheral blood, at arrival at ICU (T1) and 6 hours after arrival at ICU (T2), and 18 hours after arrival at ICU (T3).

  2. Incidence of myocardial injury on 12-lead ECG [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 2 days ]

    Incidence of myocardial injury on 12-lead ECG

    • New-onset Left bundle branch block (LBBB)
    • New-onset Q wave

  3. Vasoactive-inotropic score [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 2 days ]
    The hourly doses of the following inotropic and vasoactive medications are recorded for the first 18 h after post-operative admission to the ICU: dopamine, dobutamine, epinephrine, norepinephrine, milrinone and vasopressin.

  4. Vasoconstrictor usage [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 2 days ]
    Vasoconstrictor usage yes/no

  5. Incidence of new onset Atrial fibrillation (AF) [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 2 days ]
    Incidence of new onset AF

  6. Routine blood samples [ Time Frame: Routine blood samples will be assessed at different time points, the latest up to 6 hours after ICU arrival ]
    The amount of creatine kinase MB (CK-MB) and Creatinine at different time intervals. preoperatively from peripheral blood (T0); post-operatively, from peripheral blood, at arrival at ICU (T1) and 6 hours after arrival at ICU (T2)

  7. Mean arterial pressure (MAP) [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 2 days ]
    Haemodynamic monitoring

  8. postoperative left ventricular ejection fraction (LVEF) [ Time Frame: postoperative after skin closure, an expected average of 3 hours after starting surgery ]
    3-D transesophageal echocardiography (TEE) postoperative left ventricular ejection fraction (LVEF) after skin closure

  9. Wall Motion Score Index (WMSI) [ Time Frame: postoperative after skin closure, an expected average of 3 hours after starting surgery ]
    3-D transesophageal echocardiography (TEE) Wall Motion Score Index (WMSI) after skin closure

  10. Heart rate (HR) [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 2 days ]
    Haemodynamic monitoring. Heart rate will be measured in beats per minute (bpm).

  11. Cardiac index (CI) [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 2 days ]
    Cardiac index (CI) is a haemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA)

  12. Systemic vascular resistance index (SVRI) [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 2 days ]
    SVRI = 80 x (MAP - RAP)/CI MAP = Mean Arterial Pressure (mmHg) RAP = Right Arterial Pressure (mmHg) CI = Cardiac Index (L/min/m2)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

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): NCT02681913


Contacts
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Contact: Jeffrey Engelhart, PharmD 0031765954391 JEngelhart@amphia.nl
Contact: Thierry Scohy, MD 003176595570 TScohy@amphia.nl

Locations
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Netherlands
Amphia Hospital Recruiting
Breda, Noord-Brabant, Netherlands, 4818CK
Contact: Jeffrey Engelhart, PharmD    0031765954391    jengelhart@amphia.nl   
Contact: Thierry Scohy, MD    0031765955570    tscohy@amphia.nl   
Sponsors and Collaborators
Amphia Hospital
Investigators
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Principal Investigator: Jeffrey Engelhart, PharmD Amphia Hospital

Publications:

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Responsible Party: Jeffrey Engelhart, PharmD, MSc, Amphia Hospital
ClinicalTrials.gov Identifier: NCT02681913     History of Changes
Other Study ID Numbers: 1437
2015-001923-22 ( EudraCT Number )
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jeffrey Engelhart, Amphia Hospital:
Cardioplegia
Cardiac Surgery
Adenosine
Therapeutic Uses
Intermittent warm blood cardioplegia
Minimally Invasive Surgery
minimally invasive mitral valve plasty (mini-MPL)
minimally invasive mitral valve replacement (mini-MVR)

Additional relevant MeSH terms:
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Adenosine
Cardiomyopathies
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Cardioplegic Solutions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions