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Perioperative Effect of Atenolol on Cytokine Profiles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00202358
Recruitment Status : Unknown
Verified June 2008 by Saini Foundation.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : June 17, 2008
Medtronic - MITG
Information provided by:
Saini Foundation

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.

Condition or disease Intervention/treatment Phase
Surgery Drug: atenolol Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Perioperative Atenolol on Post-Operative Cytokines
Study Start Date : November 2002
Actual Primary Completion Date : November 2007
Estimated Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Atenolol

Arm Intervention/treatment
Placebo Comparator: placebo Drug: placebo
Experimental: atenolol Drug: atenolol

Primary Outcome Measures :
  1. Postoperative levels of IL-6 and C-Reactive protein [ Time Frame: 6 hrs, 48 hrs, 6 weeks ]

Secondary Outcome Measures :
  1. IL-10, TNF-α [ Time Frame: 6 hrs, 48 hrs, 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00202358

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United States, Massachusetts
Cape Cod Hospital
Hyannis, Massachusetts, United States, 02601
Sponsors and Collaborators
Saini Foundation
Medtronic - MITG
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Principal Investigator: Vikas Saini, M.D. Dept Medicine, Cape Cod Hospital

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Responsible Party: Vikas Saini, M.D., Cape Cod Hospital Identifier: NCT00202358    
Other Study ID Numbers: PEACK
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008
Keywords provided by Saini Foundation:
Additional relevant MeSH terms:
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Anti-Arrhythmia Agents
Antihypertensive Agents
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