SepsisNCT00360048
Oxytocin Effects on Cytokines and Endocrine Parameters After LPS Induced Systemic Inflammatory Effects in Healthy Volunteers
An observational study of Sepsis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of this study is to determine if oxytocin administration is able to blunt LPS induced increase of cytokines (TNF-α) and if there is a change in the endocrine response after lipopolysaccharide administration in humans. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- What is being tested?
- oxytocin
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2006to not given
- Phase
- Observational
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men aged 18 years or older with no disease history
- Written informed consent
Who cannot join
- Receiving any medication
- Probands who suffer from infectious disease
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine if oxytocin administration is able to blunt LPS induced increase of cytokines (TNF-α) and if there is a change in the endocrine response after lipopolysaccharide administration in humans.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
TNF-alpha
Measured: six hours
Secondary outcomes (1)
ACTH, cortisol, procalcitonin, IL-1ra, IL-4, IL-6, MIP-1alpha, MIP-1 beta, MCP-1, IP-10, VEGF, body temperature, BNP, Ghrelin,
Measured: six hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2006 (estimated)
- Study startAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Martin Clodi, MD, Associate Professor, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360048
- Sponsor's protocol ID
- 2006-000246-39
- Other IDs
- EK-Nr.: 014/2006
- Status last verified
- Dec 2007
- First submitted
- 2 Aug 2006
- Last updated
- 11 Dec 2007
- Results posted
- No
Publications
Vila G, Riedl M, Resl M, van der Lely AJ, Hofland LJ, Clodi M, Luger A. Systemic administration of oxytocin reduces basal and lipopolysaccharide-induced ghrelin levels in healthy men. J Endocrinol. 2009 Oct;203(1):175-9. doi: 10.1677/JOE-09-0227. Epub 2009 Jul 8.
PubMed 19587265
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxytocin Effects on Cytokines and Endocrine Parameters After LPS Induced Systemic Inflammatory Effects in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00360048
- Acronym / sponsor ID
- 2006-000246-39
- Conditions
- Sepsis
- Keywords
- oxytocin, tnf, sepsis, lps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2006
- First posted
- 3 Aug 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 aim of this study is to determine if oxytocin administration is able to blunt LPS induced increase of cytokines (TNF-α) and if there is a change in the endocrine response after lipopolysaccharide administration in humans.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men aged 18 years or older with no disease history
- Written informed consent
Key exclusion criteria (2 listed)
- Receiving any medication
- Probands who suffer from infectious disease
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 |
|---|---|---|
| oxytocin | Drug | – |
Primary outcome
TNF-alpha
Time frame: six hours
1 secondary outcome
ACTH, cortisol, procalcitonin, IL-1ra, IL-4, IL-6, MIP-1alpha, MIP-1 beta, MCP-1, IP-10, VEGF, body temperature, BNP, Ghrelin,
Time frame: six hours
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 11 Dec 2007.
- Derived from this study: PubMed 19587265Vila G, Riedl M, Resl M, van der Lely AJ, Hofland LJ, Clodi M, Luger A. Systemic administration of oxytocin reduces basal and lipopolysaccharide-induced ghrelin levels in healthy men. J Endocrinol. 2009 Oct;203(1):175-9. doi: 10.1677/JOE-09-0227. Epub 2009 Jul 8.
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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.
Martin Clodi, MD, Associate Professor principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Medical University of Vienna at 1 site in Austria.
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 2 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 11 Dec 2007. 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 Austria. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
TNF-alpha (time frame: six hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00360048, which also lists 1 linked publication.
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 11 Dec 2007.