Perioperative Effect of Atenolol on Cytokine Profiles - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

June 13, 2008

Start Date ^ICMJE

November 2002

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Postoperative levels of IL-6 and C-Reactive protein [ Time Frame: 6 hrs, 48 hrs, 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Postoperative levels of IL-6 and C-Reactive protein

Change History

Complete list of historical versions of study NCT00202358 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

IL-10, TNF-α [ Time Frame: 6 hrs, 48 hrs, 6 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Perioperative Effect of Atenolol on Cytokine Profiles

Official Title ^ICMJE

The Effect of Perioperative Atenolol on Post-Operative Cytokines

Brief 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Condition ^ICMJE

Surgery

Intervention ^ICMJE

Drug: atenolol
Drug: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2008

Primary Completion Date

November 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00202358

Responsible Party

Vikas Saini, M.D., Cape Cod Hospital

Study ID Numbers ^ICMJE

PEACK

Study Sponsor ^ICMJE

Saini Foundation

Collaborators ^ICMJE

Aspect Medical Systems

Investigators ^ICMJE

Principal Investigator:

Vikas Saini, M.D.

Dept Medicine, Cape Cod Hospital

Information Provided By

Saini Foundation

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP