E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patient listed for open heart surgery involving cardiopulmonary bypass. |
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E.1.1.1 | Medical condition in easily understood language |
Patient listed for open heart surgery involving cardiopulmonary bypass. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the effect of higher dose pre operative statin (80mg) on neutrophil migration, and postoperative inflammatory markers. |
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E.2.2 | Secondary objectives of the trial |
To determine the effects of preoperative statin therapy on systemic inflammatory response to CPB. Patients were divided into two groups based on preoperative dosage, group 1 (high dose, 80mg) versus group 2 (baseline statin as prescribed by primary physician); To correlate optimal dose of preoperative statins with clinical outcome post open heart surgery. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients listed for elective open heart surgery involving cardiopulmonary bypass in Mater Misericordiae University Hospital. |
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E.4 | Principal exclusion criteria |
Patients who are undergoing emergency surgery, redo surgery, intra aortic balloon pump preoperatively. Age less than 18 years. Patients whose surgery does not involve cardiopulmonary byass. Patients with underlying infection or other significant disease e.g. malignancy or inflammatory disease, on antibiotics, steroids or anti-inflammatory medication. Patients who have haemoglobin of less than 9g/dL on admission. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To investigate the effect of higher dose of pre operative statin (80mg) on neutrophil migration, by measuring inflammatory biomarkers (Interleukin-8, IL-8 and Matrix Metalloproteinase-9, MMP-9). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At induction of anaesthesia, 5-10 minutes after release of aortic cross clamp, within 12 hours post open heart surgery |
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E.5.2 | Secondary end point(s) |
To determine the effects of preoperative statin therapy on systemic inflammatory response to CPB, using heart, kidney and lung as end organ for assessment. To correlate high dose preoperative statins with clinical outcome post open heart surgery. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At induction of anaesthesia, 5-10 minutes after release of aortic cross clamp, within 12 hours post open heart surgery |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
statins (any) on baseline doses (10, 20, 40mg) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |