Endothelial DysfunctionMETSEPNCT03655899
Metabolomic Alterations in the Vascular Compartment in Patients With Sepsis
An observational study of Endothelial Dysfunction, run by Pär Johansson at 1 site in Denmark.
Trial summary
This study will investigate the metabolic alterations of vascular cells caused by sepsis and septic shock Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endothelial Dysfunction
- How many people
- 37 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Oct 2017to 12 Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sepsis or septic shock
Who may be able to join
- 18 year or older
- Sepsis or Septic shock
Who cannot join
- Pregnant or breastfeeding
- Hemoglobin ≤ 5.0 mmol/L
- Platelets ≤ 5.0 mia/L
- Consent not obtainable
- Do not resuscitate order
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolomic Alterations in the Vascular Compartment in Patients With Sepsis - an Observational Study
This study will investigate the metabolic alterations of vascular cells caused by sepsis and septic shock
Read the detailed description
This study will investigate the metabolic alterations of vascular cells caused by sepsis and septic shock in 60 patients
- Conditions
- Endothelial Dysfunction
- Keywords
- metabolomics, systems biology, Sepsis
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Shock induced endotheliopaty
Mortality
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start23 Oct 2017
- Primary completion12 Mar 2019
- Study completion12 Mar 2019
Why it stopped: Analysis of cell phenotypes was not possible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pär Johansson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pär Johansson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Pär Johansson, Study director, Rigshospitalet, Dept. of Clinical Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655899
- Sponsor's protocol ID
- Metabolomics 16024946
- Acronym
- METSEP
- Status last verified
- Sep 2019
- First submitted
- 26 Sep 2017
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Alterations in the Vascular Compartment in Patients With Sepsis - an Observational Study
- ClinicalTrials.gov ID
- NCT03655899
- Acronym / sponsor ID
- METSEP / Metabolomics 16024946
- Conditions
- Endothelial Dysfunction
- Keywords
- metabolomics, systems biology, Sepsis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Analysis of cell phenotypes was not possible
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Pär JohanssonUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 12 Mar 2019 (actual)
- Study completion
- 12 Mar 2019 (actual)
- First posted
- 31 Aug 2018 (actual)
- 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.
This study will investigate the metabolic alterations of vascular cells caused by sepsis and septic shock
Detailed description
This study will investigate the metabolic alterations of vascular cells caused by sepsis and septic shock in 60 patients
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sepsis or septic shock
Key inclusion criteria (2 listed)
- 18 year or older
- Sepsis or Septic shock
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding
- Hemoglobin ≤ 5.0 mmol/L
- Platelets ≤ 5.0 mia/L
- Consent not obtainable
- Do not resuscitate order
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Shock induced endotheliopaty
Time frame: Up to 30 days
Mortality
Results and safety
The study was stopped early (reason given: Analysis of cell phenotypes was not possible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
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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.
Pär Johansson study director
Rigshospitalet, Dept. of Clinical Immunology
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 Endothelial Dysfunction, run by Pär Johansson 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 5 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: stopped early, as of the sponsor's last update on 12 Sep 2019. 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. 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 was stopped early (reason given: Analysis of cell phenotypes was not possible). 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?
Shock induced endotheliopaty (time frame: Up to 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 12 Sep 2019.