Perioperative Effect of Atenolol on Cytokine Profiles
The Effect of Perioperative Atenolol on Post-Operative Cytokines
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 surgery
Started Nov 2002
Longer than P75 for phase_4 surgery
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedJune 17, 2008
June 1, 2008
5 years
September 12, 2005
June 13, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative levels of IL-6 and C-Reactive protein
6 hrs, 48 hrs, 6 weeks
Secondary Outcomes (1)
IL-10, TNF-α
6 hrs, 48 hrs, 6 weeks
Study Arms (2)
placebo
PLACEBO COMPARATORatenolol
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- elective abdominal, orthopedic, or gynecologic surgery
- ability to give informed consent
- ability to tolerate beta-blocker therapy
- ability to comply with follow-up requirements
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Saini Foundationlead
- Medtronic - MITGcollaborator
Study Sites (1)
Cape Cod Hospital
Hyannis, Massachusetts, 02601, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vikas Saini, M.D.
Dept Medicine, Cape Cod Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
November 1, 2002
Primary Completion
November 1, 2007
Study Completion
September 1, 2008
Last Updated
June 17, 2008
Record last verified: 2008-06