SurgeryPhase 4NCT00202358
Perioperative Effect of Atenolol on Cytokine Profiles
A Phase 4 study testing atenolol in people with Surgery, run by Saini Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- atenolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Sep 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective abdominal, orthopedic, or gynecologic surgery
- ability to give informed consent
- ability to tolerate beta-blocker therapy
- ability to comply with follow-up requirements
Who cannot join
- 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
Show all 9Show fewer
- history of Crohn's disease
- history of lupus
- history of inflammatory cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Surgery
- Being tested
- atenolol, placebo
- Keywords
- perioperative, beta-blockers, inflammation, outcomes
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atenololDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| atenolol | Experimental | Not described Receives: Drug: atenolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative levels of IL-6 and C-Reactive protein
Measured: 6 hrs, 48 hrs, 6 weeks
Secondary outcomes (1)
IL-10, TNF-α
Measured: 6 hrs, 48 hrs, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startNov 2002
- Primary completionNov 2007
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saini Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Investigators
- Vikas Saini, M.D., Principal investigator, Dept Medicine, Cape Cod Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202358
- Sponsor's protocol ID
- PEACK
- Status last verified
- Jun 2008
- First submitted
- 12 Sep 2005
- Last updated
- 17 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Atenolol on Post-Operative Cytokines
- ClinicalTrials.gov ID
- NCT00202358
- Acronym / sponsor ID
- PEACK
- Conditions
- Surgery
- Keywords
- perioperative, beta-blockers, inflammation, outcomes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saini FoundationUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Nov 2002
- Primary completion
- Nov 2007 (actual)
- Study completion
- Sep 2008 (estimated)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| atenolol | Experimental | Drug: atenolol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- elective abdominal, orthopedic, or gynecologic surgery
- ability to give informed consent
- ability to tolerate beta-blocker therapy
- ability to comply with follow-up requirements
Key exclusion criteria (9 listed)
- currently receiving beta-blocker therapy
- EKG documented 2nd or 3rd degree heart block
- EKG documented sinus bradycardia
- Serum creatinine > 2.0
- current treatment asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atenolol | Drug | atenolol |
| placebo | Drug | placebo |
Primary outcome
Postoperative levels of IL-6 and C-Reactive protein
Time frame: 6 hrs, 48 hrs, 6 weeks
1 secondary outcome
IL-10, TNF-α
Time frame: 6 hrs, 48 hrs, 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vikas Saini, M.D. principal investigator
Dept Medicine, Cape Cod Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing atenolol in people with Surgery, run by Saini Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative levels of IL-6 and C-Reactive protein (time frame: 6 hrs, 48 hrs, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2008.