Perioperative Effect of Atenolol on Cytokine Profiles

NCT ID: NCT00202358

Last Updated: 2008-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2008-09-30

Brief Summary

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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

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Conditions

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Surgery

Keywords

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perioperative beta-blockers inflammation outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

atenolol

Group Type EXPERIMENTAL

atenolol

Intervention Type DRUG

Interventions

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atenolol

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role collaborator

Saini Foundation

OTHER

Sponsor Role lead

Responsible Party

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Cape Cod Hospital

Principal Investigators

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Vikas Saini, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dept Medicine, Cape Cod Hospital

Locations

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Cape Cod Hospital

Hyannis, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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PEACK

Identifier Type: -

Identifier Source: org_study_id