Adenosine as an adjunct to standaard blood cardioplegia

The effect of adenosine on myocardial protection in intermittent warm blood cardioplegia: a randomized placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001923-22-NL

Enrollment

100

Registered

2015-11-19

Start date

2015-12-16

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative cardiac damage in patients scheduled for minimal invasive, port-access operations

Interventions

Trade Name: Adenocor Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: Adenosine Other descriptive name: ADENOSI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Gender; male/ female • Age: = 18 year •Elective cardiac surgical patients: - minimally invasive, port access surgery (mitral valve surgery) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will be excluded from participation in this study: • All non-minimally invasive surgery • Theophylline or dipyridamole use • Caffeine use up to 12 hours prior to surgery

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this study is to determine whether adenosine-enriched intermittent 20:1 diluted warm blood cardioplegic solution compared to standard intermittent 20:1 diluted warm blood cardioplegic solution improves 6-hours postoperative myocardial protection, determined as cardaic troponine T (cTnT ) in patients scheduled for minimally invasive, port access operations (mitral valve surgery). ; Secondary Objective: As secondary objectives, we would like to evaluate differences in the 18-hours postoperative area-under-the-curve (AUC) release of cTnT, pre- and postoperative enzymatic release of creatinine kinase-MB (CK-MB), mean arterial pressure, heart rate, cardiac index, systemic vascular resistance index, and inotropic score, incidence of new onset atrial fibrillation, and differences in pre- and postoperative left ventricular ejection fraction (LVEF) and wall motion score index (WMSI) determined by 3-dimensional transesophageal echocardiography (TEE). ;Primary end point(s): The primary end point is post-operative 6-hour cardiac troponin T release. ;Timepoint(s) of evaluation of this end point: Post-operative 6 hours after surgical procedure.	—

Measure

Time frame

Main Objective: The main objective of this study is to determine whether adenosine-enriched intermittent 20:1 diluted warm blood cardioplegic solution compared to standard intermittent 20:1 diluted warm blood cardioplegic solution improves 6-hours postoperative myocardial protection, determined as cardaic troponine T (cTnT ) in patients scheduled for minimally invasive, port access operations (mitral valve surgery). ; Secondary Objective: As secondary objectives, we would like to evaluate differences in the 18-hours postoperative area-under-the-curve (AUC) release of cTnT, pre- and postoperative enzymatic release of creatinine kinase-MB (CK-MB), mean arterial pressure, heart rate, cardiac index, systemic vascular resistance index, and inotropic score, incidence of new onset atrial fibrillation, and differences in pre- and postoperative left ventricular ejection fraction (LVEF) and wall motion score index (WMSI) determined by 3-dimensional transesophageal echocardiography (TEE). ;Primary end point(s): The primary end point is post-operative 6-hour cardiac troponin T release. ;Timepoint(s) of evaluation of this end point: Post-operative 6 hours after surgical procedure.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary cardiac end points are: • 18-hour postoperative AUC release of cardiac troponine 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). • Incidence of myocardial injury on 12-lead ECG - New-onset Left bundle branch block (LBBB) - New-onset Q wave • Vasoactive-inotropic score • Vasoconstrictor usage • Incidence of new onset AF • Routine blood samples preoperatively from peripheral blood (T0); post-operatively, from peripheral blood, at arrival at ICU (T1) and 6 hours after arrival at ICU (T2) ? CK-MB ? Creatinine • Haemodynamic monitoring ? Mean arterial pressure ? Heart rate ? Cardiac index ? Systemic vascular resistance index • 3-D TEE postoperative LVEF and Wall Motion Score Index (WMSI) after skin closure ; Timepoint(s) of evaluation of this end point: preoperative one day post-operative at arrival at ICU, one day, discharge ICU	—

Measure

Time frame

Secondary end point(s): Secondary cardiac end points are: • 18-hour postoperative AUC release of cardiac troponine 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). • Incidence of myocardial injury on 12-lead ECG - New-onset Left bundle branch block (LBBB) - New-onset Q wave • Vasoactive-inotropic score • Vasoconstrictor usage • Incidence of new onset AF • Routine blood samples preoperatively from peripheral blood (T0); post-operatively, from peripheral blood, at arrival at ICU (T1) and 6 hours after arrival at ICU (T2) ? CK-MB ? Creatinine • Haemodynamic monitoring ? Mean arterial pressure ? Heart rate ? Cardiac index ? Systemic vascular resistance index • 3-D TEE postoperative LVEF and Wall Motion Score Index (WMSI) after skin closure ; Timepoint(s) of evaluation of this end point: preoperative one day post-operative at arrival at ICU, one day, discharge ICU

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Countries

Netherlands

Contacts

Public ContactClinical Trials Information

Amphia Ziekenhuis

jengelhart@amphia.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026