Perioperative Effect of Atenolol on Cytokine Profiles
Information source: Saini Foundation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Surgery
Intervention: atenolol (Drug); placebo (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Saini Foundation Official(s) and/or principal investigator(s):
Vikas Saini, M.D., Principal Investigator, Affiliation: Dept Medicine, Cape Cod Hospital
Summary
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.
Clinical Details
Official title: The Effect of Perioperative Atenolol on Post-Operative Cytokines
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Primary outcome: Postoperative levels of IL-6 and C-Reactive protein
Secondary outcome: IL-10, TNF-α
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Cape Cod Hospital, Hyannis, Massachusetts 02601, United States
Additional Information
Starting date: November 2002
Ending date: September 2008
Last updated: June 13, 2008
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