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...
Date First Received: September 12, 2005
Last Updated: June 13, 2008
Verified by: Saini Foundation, June 2008
Clinical Trial Phase: Phase 4 | Start Date: November 2002
Overall Status: Active, not recruiting
Estimated Enrollment: 60
Brief Summary
Official Title: “The Effect of Perioperative Atenolol on Post-Operative Cytokines”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Study Primary Completion Date: November 2007
Intervention(s) in this Clinical Trial
- Drug: atenolol
- Drug: placebo
Arms, Groups and Cohorts in this Clinical Trial
- Placebo Comparator: placebo
- Experimental: atenolol
Outcome Measures for this Clinical Trial
Primary Measures
- Postoperative levels of IL-6 and C-Reactive protein
- Time Frame: 6 hrs, 48 hrs, 6 weeks
Safety Issue?: No
- Time Frame: 6 hrs, 48 hrs, 6 weeks
Secondary Measures
- IL-10, TNF-α
- Time Frame: 6 hrs, 48 hrs, 6 weeks
Safety Issue?: No
- Time Frame: 6 hrs, 48 hrs, 6 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- elective abdominal, orthopedic, or gynecologic surgery
- ability to give informed consent
- ability to tolerate beta-blocker therapy
- ability to comply with follow-up requirements
Exclusion Criteria:
- currently receiving beta-blocker therapy
- EKG documented 2nd or 3rd degree heart block
- EKG documented sinus bradycardia
- Serum creatinine > 2.0
- current treatment asthma
- history of rheumatoid arthritis
- history of Crohn's disease
- history of lupus
- history of inflammatory cancer
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Saini Foundation
Overall Clinical Trial Officials and Contacts
Vikas Saini, M.D. Principal Investigator Dept Medicine, Cape Cod Hospital
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00202358
Study ID Number: PEACK
ClinicalTrials.gov Identifier: NCT00202358
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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