Glycemia During Coronary Artery Bypass GraftPhase 4NCT01619436
The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass
A Phase 4 study testing Clonidine and Ringer lactato in people with Glycemia During Coronary Artery Bypass Graft and Sedation During Pre-anesthetic Medication, run by Federal University of Juiz de Fora at 1 site in Brazil.
Trial summary
The purpose of this study is the randomized blind research of the assessment of the different levels of glycemia during Coronary Artery Bypass Graft (CABG) with cardiopulmonary by-pass (CPB) between clonidine and placebo. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Glycemia During Coronary Artery Bypass Graft, Sedation During Pre-anesthetic Medication
- What is being tested?
- Clonidine and Ringer lactato
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to May 2012
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective CABG EF > 40% Sinus ritmy
Who cannot join
- precordialgia emergency surgery combinated surgery not agreement
Trial locations and contacts
1 site in 1 country.
Brazil1 site
National institut of Cardiology
Rio de Janeiro, Rio de Janeiro, 3600/100
About this study
Official title: The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass.
The purpose of this study is the randomized blind research of the assessment of the different levels of glycemia during Coronary Artery Bypass Graft (CABG) with cardiopulmonary by-pass (CPB) between clonidine and placebo. As clonidine decrease the inflammatory response during cardiac surgery, the investigators would like to know if the glycemia levels in clondine group will be lower than placebo group.
- Being tested
- Clonidine, Ringer lactato
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
bolus, clonidine 2 mg/kg IV
Ringer lactatoDrug
1 ML ringer lactato IV, as placebo
| Study group | Role | What they receive |
|---|---|---|
| clonidine | Active comparator | clonidine 2 mg/kg IV Receives: Drug: Clonidine |
| ringer lactato 1 ml | Placebo comparator | Ringer lactato 1 ml IV as Placebo Receives: Drug: Ringer lactato |
What is being measured
The primary outcome is the main question the study is designed to answer.
sedation
Clonidine 2 mg/kg IV. assessment sedation with Ransay scale
Measured: 2 years
Secondary outcomes (1)
Glycemia
clonide 2 mg/kg. assessment the glycemia during CPB.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemia During Coronary Artery Bypass GraftStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcello F Salgado Filho, MD, Federal University of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619436
- Sponsor's protocol ID
- 0279/03.05.2010
- Status last verified
- Jun 2012
- First submitted
- 12 Jun 2012
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass.
- ClinicalTrials.gov ID
- NCT01619436
- Acronym / sponsor ID
- 0279/03.05.2010
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Jun 2012 (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.
The purpose of this study is the randomized blind research of the assessment of the different levels of glycemia during Coronary Artery Bypass Graft (CABG) with cardiopulmonary by-pass (CPB) between clonidine and placebo. As clonidine decrease the inflammatory response during cardiac surgery, the investigators would like to know if the glycemia levels in clondine group will be lower than placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clonidine | Active comparator | Drug: Clonidineclonidine 2 mg/kg IV |
| ringer lactato 1 ml | Placebo comparator | Drug: Ringer lactatoRinger lactato 1 ml IV as Placebo |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective CABG EF > 40% Sinus ritmy
Key exclusion criteria (1 listed)
- precordialgia emergency surgery combinated surgery not agreement
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 |
|---|---|---|
| Clonidinebolus, clonidine 2 mg/kg IV | Drug | clonidine |
| Ringer lactato1 ML ringer lactato IV, as placebo | Drug | ringer lactato 1 ml |
Primary outcome
sedation
Time frame: 2 years
Clonidine 2 mg/kg IV. assessment sedation with Ransay scale
1 secondary outcome
Glycemia
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2012.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Clonidine and Ringer lactato in people with Glycemia During Coronary Artery Bypass Graft and Sedation During Pre-anesthetic Medication, run by Federal University of Juiz de Fora at 1 site in Brazil.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Jun 2012. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
sedation (time frame: 2 years). 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 14 Jun 2012; AzTrials last refreshed its copy on 8 Nov 2026.