Critically IllNCT00303043
Hemodynamic Monitoring With Mixed Venous Saturation
An observational study of Critically Ill, run by Policlinico Hospital at 1 site in Italy.
Trial summary
In this study the investigators aim to evaluate the utility of a continuous mixed venous saturation monitoring compared to a clinical examination in a group of critically ill patients. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Critically Ill
- What is being tested?
- Mixed venous saturation monitoring
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2006to Jul 2009
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critically ill patients with a central venous catheter
Who may be able to join
- Critically ill patients with a central venous catheter
Who cannot join
- Patients with pulmonary catheter
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Ospedale Maggiore Policlinico Mangiagalli Regina Elena
Milan, mi, 20145
About this study
Official title: Hemodynamic Monitoring. The Continuous Measurement of Mixed Venous Saturation Compared to Clinical Valuation: A Pilot Study
In this study the investigators aim to evaluate the utility of a continuous mixed venous saturation monitoring compared to a clinical examination in a group of critically ill patients.
Read the detailed description
We will compare possible difference in terms of sensibility and specificity regarding the continuous mixed venous saturation monitoring compared to clinical examination in a group of critically ill patients.
- Conditions
- Critically Ill
- Being tested
- Mixed venous saturation monitoring
- Keywords
- Hemodynamic monitoring, Mixed venous saturation, Critically ill patients
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed venous saturation monitoringProcedure or surgery
Mixed venous saturation monitoring
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Procedure: Mixed venous saturation monitoring |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Davide Chiumello, MD, Principal investigator, Fondazione Ospedale Maggiore Policlinico Mangiagalli Regina Elena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303043
- Sponsor's protocol ID
- 2000
- Status last verified
- Mar 2009
- First submitted
- 14 Mar 2006
- Last updated
- 30 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Monitoring. The Continuous Measurement of Mixed Venous Saturation Compared to Clinical Valuation: A Pilot Study
- ClinicalTrials.gov ID
- NCT00303043
- Acronym / sponsor ID
- 2000
- Conditions
- Critically Ill
- Keywords
- Hemodynamic monitoring, Mixed venous saturation, Critically ill patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 Mar 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.
In this study the investigators aim to evaluate the utility of a continuous mixed venous saturation monitoring compared to a clinical examination in a group of critically ill patients.
Detailed description
We will compare possible difference in terms of sensibility and specificity regarding the continuous mixed venous saturation monitoring compared to clinical examination in a group of critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Mixed venous saturation monitoring |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill patients with a central venous catheter
Key inclusion criteria (1 listed)
- Critically ill patients with a central venous catheter
Key exclusion criteria (1 listed)
- Patients with pulmonary catheter
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 |
|---|---|---|
| Mixed venous saturation monitoringMixed venous saturation monitoring | Procedure or surgery | 1 |
Primary outcome
Not reported in the source record.
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 Dec 2009.
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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.
Davide Chiumello, MD principal investigator
Fondazione Ospedale Maggiore Policlinico Mangiagalli Regina Elena
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 Critically Ill, run by Policlinico Hospital 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 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 30 Dec 2009. 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 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.
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 Dec 2009.