Perioperative Effect of Atenolol on Cytokine Profiles

June 13, 2008 updated by: Saini Foundation

The Effect of Perioperative Atenolol on Post-Operative Cytokines

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
Experimental: atenolol
Drug: atenolol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative levels of IL-6 and C-Reactive protein
Time Frame: 6 hrs, 48 hrs, 6 weeks
6 hrs, 48 hrs, 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
IL-10, TNF-α
Time Frame: 6 hrs, 48 hrs, 6 weeks
6 hrs, 48 hrs, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saini Foundation

Collaborators

Medtronic - MITG

Investigators

  • Principal Investigator: Vikas Saini, M.D., Dept Medicine, Cape Cod Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Primary Completion (Actual)

November 1, 2007

Study Completion (Anticipated)

September 1, 2008

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

June 17, 2008

Last Update Submitted That Met QC Criteria

June 13, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEACK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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