Is the optimal dose of statin given before open heart surgery involving cardiopulmonary bypass associated with decreased organs injury and better recovery?

Conditions: Patient listed for open heart surgery involving cardiopulmonary bypass.
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2012-003396-20-IE

Lead Sponsor: Cardiothoracic Surgery, Mater Misericordiae University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients listed for elective open heart surgery involving cardiopulmonary bypass in Mater Misericordiae University Hospital.
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the effect of higher dose pre operative statin (80mg) on neutrophil migration, and postoperative inflammatory markers.;Secondary Objective: 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.;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).;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

Secondary Outcome Measures

Name	Time	Method
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.;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