The effect of Adenosine on Myocardial Protection in Intermittent warm blood Cardioplegia: a randomized placebo-controlled trial

The effect of Adenosine on Myocardial Protection in Intermittent warm blood Cardioplegia: a randomized placebo-controlled trial - Adenosine as an adjunct to blood cardioplegia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42535

Enrollment

100

Registered

2015-10-28

Start date

2016-02-04

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Heart diseases (minimally invasive port access operations (mitral valve surgery))

Interventions

during cardiopulmonary bypass one group receives standard cardioplegic solution (control), the second group receives cardioplegic solution enriched with adenosine (intervention). To maintain cardiop

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Gender; male/ female * Age: * 18 year *Elective cardiac surgical patients: - minimally invasive, port-access surgery (mitral valve surgery)

Exclusion criteria

Exclusion criteria: Other types of cardiac surgery patients Theophylline or dipyridamole use up to 24 hours prior to surgery Caffeine use up to 12 hours prior to surgery Other xantthine derivatives

Design outcomes

Primary

Measure	Time frame
the main study parameter is 6 hours post-operative cTnT.	—

Secondary

Measure	Time frame
Secondary outcomes are differences in 18-hour postoperative cTnT levels as determined by the area-under-the-curve (AUC), differences in pre- and post-operative creatine kinase-MB (CK-MB) levels, inotrope usage and dosage, and differences in pre- and postoperative left ventricular ejection fraction (LVEF) and wall motion score index (WMSI) determined by 3-dimensional transesophageal echocardiography (TEE). Furthermore we will compare routine hemodynamic monitoring (i.e. mean arterial pressure, heart rate, cardiac index, and systemic vascular resistance index). Incidence of new onset atrial fibrillation will also be monitored.	—

Measure

Time frame

Secondary outcomes are differences in 18-hour postoperative cTnT levels as determined by the area-under-the-curve (AUC), differences in pre- and post-operative creatine kinase-MB (CK-MB) levels, inotrope usage and dosage, and differences in pre- and postoperative left ventricular ejection fraction (LVEF) and wall motion score index (WMSI) determined by 3-dimensional transesophageal echocardiography (TEE). Furthermore we will compare routine hemodynamic monitoring (i.e. mean arterial pressure, heart rate, cardiac index, and systemic vascular resistance index). Incidence of new onset atrial fibrillation will also be monitored.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)