Perioperative Effect of Atenolol on Cytokine Profiles

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2008 by Saini Foundation. Recruitment status was Active, not recruiting

First Received on September 12, 2005. Last Updated on June 13, 2008 History of Changes

Sponsor:	Saini Foundation
Collaborator:	Covidien
Information provided by:	Saini Foundation
ClinicalTrials.gov Identifier:	NCT00202358

Purpose

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
Surgery	Drug: atenolol Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	The Effect of Perioperative Atenolol on Post-Operative Cytokines

Resource links provided by NLM:

Drug Information available for: Atenolol

U.S. FDA Resources

Further study details as provided by Saini Foundation:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

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
Placebo Comparator: placebo	Drug: placebo
Experimental: atenolol	Drug: atenolol

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202358

Locations

United States, Massachusetts
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601

Sponsors and Collaborators

Saini Foundation

Covidien

Investigators

Principal Investigator:

Vikas Saini, M.D.

Dept Medicine, Cape Cod Hospital

More Information

No publications provided

Responsible Party:	Vikas Saini, M.D., Cape Cod Hospital
ClinicalTrials.gov Identifier:	NCT00202358 History of Changes
Other Study ID Numbers:	PEACK
Study First Received:	September 12, 2005
Last Updated:	June 13, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Saini Foundation:

perioperative
beta-blockers
inflammation
outcomes

Additional relevant MeSH terms:

Atenolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012