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Sponsors and Collaborators: |
Saini Foundation Aspect Medical Systems |
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Information provided by: | Saini Foundation |
ClinicalTrials.gov Identifier: | NCT00202358 |
Studies have shown that beta-blockers such as atenolol when given in the perioperative period reduce morbidity and mortality. One study showed that atenolol given just during the surgery period, seemed to improve outcomes up to 2 years later. This is hard to explain since beta-blockers act on the body by blocking the effects of adrenalin and thereby lowering heart rate and blood pressure.
This study is designed to find out if perioperative atenolol might exert its long term effects through an anti-inflammatory mechanism rather than by lowering heart rate and blood pressure. It is known that inflammation increases after surgery as part of the healing process. However, it is also becoming clear that low-grade chronic inflammation can also lead to long term adverse effects.
Condition | Intervention | Phase |
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Surgery |
Drug: atenolol Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | The Effect of Perioperative Atenolol on Post-Operative Cytokines |
Estimated Enrollment: | 60 |
Study Start Date: | November 2002 |
Estimated Study Completion Date: | September 2008 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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placebo: Placebo Comparator | Drug: placebo |
atenolol: Experimental | Drug: atenolol |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Cape Cod Hospital | |
Hyannis, Massachusetts, United States, 02601 |
Principal Investigator: | Vikas Saini, M.D. | Dept Medicine, Cape Cod Hospital |
Responsible Party: | Cape Cod Hospital ( Vikas Saini, M.D. ) |
Study ID Numbers: | PEACK |
Study First Received: | September 12, 2005 |
Last Updated: | June 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00202358 |
Health Authority: | United States: Institutional Review Board |
perioperative beta-blockers inflammation outcomes |
Atenolol Inflammation |
Sympatholytics Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents |
Pharmacologic Actions Autonomic Agents Therapeutic Uses Adrenergic beta-Antagonists Adrenergic Antagonists Anti-Arrhythmia Agents Peripheral Nervous System Agents |