Aortic AneurysmPhase 2/3NCT00315926
Melatonin and Cardiac Outcome After Major Surgery
A Phase 2/3 study testing Melatonin in people with Aortic Aneurysm, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to assess whether treatment with melatonin can reduce cell damage and inflammatory stress response and thereby occurrence of myocardial injury after abdominal aortic surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2007to Jul 2008
- Phase
- Phase 2/3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for elective abdominal aortic aneurism surgery or periphery atheroscleroses with indicated protheses operation
- Patients between 18 and 80 years old
Who cannot join
- Patients with ASA class > 3
- Anticoagulation therapy (marevan and marcoumar)
- Preoperative therapy with opioid, anxiolytic and hypnotic medication
- Renal insufficient (preoperative creatinin > 200 mmol/l)
- Well-known liver insufficient
- Alcohol consumption (more than 5 drinks)
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- Compliance (language difficulty, mental problems etc.)
- Pregnancy and breast-feeding
- Lack of written consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
Hellerup
About this study
Official title: Melatonin and Cardiac Morbidity After Elective Abdominal Aortic Aneurism Repair
The purpose of this study is to assess whether treatment with melatonin can reduce cell damage and inflammatory stress response and thereby occurrence of myocardial injury after abdominal aortic surgery.
Read the detailed description
Abdominal aortic surgery is associated with a significant increase of oxidative and inflammatory stress response. Aortic surgery is also associated with elevated troponin which is a sensitive and specific marker for myocardial injury. The severity of oxidative stress is correlated with elevated troponin. Melatonin, which is a hormone produced in brain, seems to modify cell damage and inflammation. On the other hand we know, that melatonin production first night after surgery is disturbed. The purpose of this study is therefore to determine whether treatment with melatonin can reduce cell damage and inflammation, and thereby occurrence of myocardial injury associated with abdominal aortic surgery.
- Conditions
- Aortic Aneurysm
- Being tested
- Melatonin, Placebo
- Keywords
- Cardiac morbidity, Melatonin, Surgery, Postoperative
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Melatonin 50 mg during surgery and 10 mg every night for 3 nights
PlaceboDrug
a mixture of ethanol and physiological saline
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Not described Receives: Drug: Melatonin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac morbidity
artrial fibrillation, unstable angina, myocardial infarction, ECG changes (T-wave inversion for more than 24 hours, new ST-segment depression for more than 24 hours, acute ST-segment elevation with appearance of q-waves or loss of R-waves, left bundle branch block), or a characteristic pattern of rising and falling values of troponin-I, or pulmonary oedema. Mortality was defined as any cause of death in the 30 days after surgery.
Measured: 30 days
Secondary outcomes (1)
Oxidative and inflammatory stress response
Blood samples for analysis of malondialdehyde (MDA), ascorbic acid (AA), dehydroascorbic acid (DHA) and C-reactive protein (CRP) assessed before and after operation
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2006 (estimated)
- Study startJan 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic AneurysmStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Bülent Kücükakin, Principal investigator, Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315926
- Sponsor's protocol ID
- 2612-3109
- Status last verified
- Nov 2006
- First submitted
- 18 Apr 2006
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin and Cardiac Morbidity After Elective Abdominal Aortic Aneurism Repair
- ClinicalTrials.gov ID
- NCT00315926
- Acronym / sponsor ID
- 2612-3109
- Conditions
- Aortic Aneurysm
- Keywords
- Cardiac morbidity, Melatonin, Surgery, Postoperative
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 19 Apr 2006 (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 to assess whether treatment with melatonin can reduce cell damage and inflammatory stress response and thereby occurrence of myocardial injury after abdominal aortic surgery.
Detailed description
Abdominal aortic surgery is associated with a significant increase of oxidative and inflammatory stress response. Aortic surgery is also associated with elevated troponin which is a sensitive and specific marker for myocardial injury. The severity of oxidative stress is correlated with elevated troponin. Melatonin, which is a hormone produced in brain, seems to modify cell damage and inflammation. On the other hand we know, that melatonin production first night after surgery is disturbed. The purpose of this study is therefore to determine whether treatment with melatonin can reduce cell damage and inflammation, and thereby occurrence of myocardial injury associated with abdominal aortic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Drug: Melatonin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for elective abdominal aortic aneurism surgery or periphery atheroscleroses with indicated protheses operation
- Patients between 18 and 80 years old
Key exclusion criteria (9 listed)
- Patients with ASA class > 3
- Anticoagulation therapy (marevan and marcoumar)
- Preoperative therapy with opioid, anxiolytic and hypnotic medication
- Renal insufficient (preoperative creatinin > 200 mmol/l)
- Well-known liver insufficient
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 |
|---|---|---|
| MelatoninMelatonin 50 mg during surgery and 10 mg every night for 3 nights | Drug | Melatonin |
| Placeboa mixture of ethanol and physiological saline | Drug | Placebo |
Primary outcome
Cardiac morbidity
Time frame: 30 days
artrial fibrillation, unstable angina, myocardial infarction, ECG changes (T-wave inversion for more than 24 hours, new ST-segment depression for more than 24 hours, acute ST-segment elevation with appearance of q-waves or loss of R-waves, left bundle branch block), or a characteristic pattern of rising and falling values of troponin-I, or pulmonary oedema. Mortality was defined as any cause of death in the 30 days after surgery.
1 secondary outcome
Oxidative and inflammatory stress response
Time frame: 3 days
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 30 Jun 2010.
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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.
Bülent Kücükakin principal investigator
Department of Surgical Gastroenterology, University Hospital of Copenhagen in Gentofte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Melatonin in people with Aortic Aneurysm, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
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 2 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: finished, as of the sponsor's last update on 30 Jun 2010. 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 Denmark. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Cardiac morbidity (time frame: 30 days). 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 30 Jun 2010.