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

Is the optimal dose of preoperative statin associated with decreased end organ injury and better clinical outcome post cardiopulmonary bypass?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003396-20-IE

Enrollment

Registered

2012-09-06

Start date

2012-11-26

Completion date

Unknown

Last updated

2025-04-14

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

Conditions

Patient listed for open heart surgery involving cardiopulmonary bypass.

Interventions

Trade Name: Lipitor Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Atorvastatin Calcium Trihydrate CAS Number: S 40054-69-1 Current Sponsor code: MMUH-Conway01 Other descriptive name: AT

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Ireland

Contacts

Public ContactYie Roei Chee- Research Registrar

Cardiothoracic Surgery, Mater Misericordiae University Hospital

yrchee@mater.ie35318032823

Outcome results

None listed

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