MetabolomicNCT01506674
Metabolomic in Critical Ill Patients
An observational study of Metabolomic, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
Analysis of blood, urinary, and intrathecal metabolites of critical ill patients will be checked for possible correlations between metabolomics patterns and patients' outcomes. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Metabolomic
- How many people
- 94 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jan 2015to 6 Apr 2023
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critical ill patients
Who may be able to join
- patients with severe left or right ventricular dysfunction undergoing cardiac surgery
- patients undergoing ablation of ventricular tachycardia
- patients with febrile neutropenia after chemotherapy or allogeneic transplant for haematological diseases
- patients undergoing thoracoabdominal vascular surgery
Who cannot join
- pregnant women
- no written consent
Trial locations and contacts
1 site in 1 country.
About this study
Analysis of blood, urinary, and intrathecal metabolites of critical ill patients will be checked for possible correlations between metabolomics patterns and patients' outcomes.
- Conditions
- Metabolomic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| criticall ill patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomic patterns to identify poor outcome
Measured: hospital stay (approximately two weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study start27 Jan 2015
- Primary completion31 Oct 2017
- Study completion6 Apr 2023
Why it stopped: The study was terminated prematurely due to slow recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolomicStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Landoni, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506674
- Sponsor's protocol ID
- HSR CEmet
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2012
- Last updated
- 18 Jan 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic in Critical Ill Patients
- ClinicalTrials.gov ID
- NCT01506674
- Acronym / sponsor ID
- HSR CEmet
- Conditions
- Metabolomic
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely due to slow recruitment.
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- 27 Jan 2015 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 10 Jan 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.
Analysis of blood, urinary, and intrathecal metabolites of critical ill patients will be checked for possible correlations between metabolomics patterns and patients' outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| criticall ill patients | – | – |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critical ill patients
Key inclusion criteria (4 listed)
- patients with severe left or right ventricular dysfunction undergoing cardiac surgery
- patients undergoing ablation of ventricular tachycardia
- patients with febrile neutropenia after chemotherapy or allogeneic transplant for haematological diseases
- patients undergoing thoracoabdominal vascular surgery
Key exclusion criteria (2 listed)
- pregnant women
- no written consent
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
Metabolomic patterns to identify poor outcome
Time frame: hospital stay (approximately two weeks)
Results and safety
The study was stopped early (reason given: The study was terminated prematurely due to slow recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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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.
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?
An observational study of Metabolomic, run by Università Vita-Salute San Raffaele at 1 site in Italy.
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 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: stopped early, as of the sponsor's last update on 18 Jan 2024. 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 Italy. 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: The study was terminated prematurely due to slow recruitment.). 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?
Metabolomic patterns to identify poor outcome (time frame: hospital stay (approximately two 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 18 Jan 2024.