MeSH Heading Cardiac Surgical ProceduresNCT01425931
Gastrointestinal Microcirculation During Cardiopulmonary Bypass
An observational study of MeSH Heading Cardiac Surgical Procedures and Tree Number E04.100.376, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
O2C is a diagnostic device for non-invasive determination of oxygen supply in microcirculation of blood perfused tissues. The optical sensor is easy to handle and guarantees reproducible examinations of local oxygen supply of tissues in clinics as well as in research. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- MeSH Heading Cardiac Surgical Procedures, Tree Number E04.100.376, Tree Number E04.928.220
- What is being tested?
- Heart Lung machine
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2014to Aug 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac surgery patients with ecc
Who may be able to join
- Patients on extracorporeal circulation
Who cannot join
- Haemorrhoidal lesions
Trial locations and contacts
1 site in 1 country.
About this study
O2C is a diagnostic device for non-invasive determination of oxygen supply in microcirculation of blood perfused tissues. The optical sensor is easy to handle and guarantees reproducible examinations of local oxygen supply of tissues in clinics as well as in research. The examinations are without any strain for your patient.
Determines by use of a glass fibre probe:
Read more
Blood Flow in Microcirculation Capillary-Venous Oxygen Saturation Blood Filling of Microvessels Blood Flow Velocity This device makes it possible to supervise the local oxygen supply of organs and tissue.
With it is possible to measure locally the amount of oxygen which is transported into the region of interest and to diagnose local oxygen consumption of an organ. O2C's novelty is monitoring the energetic metabolism of cells by measuring the oxygen uptake with an optical sensor probe. Pathological O2-supply, which can lead to angiogenesis or cell-death and subsequently to organ failure, now can be detected in an early state by use of the new sensor system.
One of these new developed sensors are used to place in rectal position during extracorporeal circulation to determine the microcirculation.
- Conditions
- MeSH Heading Cardiac Surgical Procedures, Tree Number E04.100.376, Tree Number E04.928.220
- Being tested
- Heart Lung machine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Lung machineProcedure or surgery
measurement of microcirculation with O2C device
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal circulation | all patients were measured by microcirculation device O2C Receives: Procedure: Heart Lung machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Flow in Microcirculation
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startJun 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeSH Heading Cardiac Surgical ProceduresStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425931
- Sponsor's protocol ID
- O2C-001AHK
- Status last verified
- Aug 2014
- First submitted
- 23 Aug 2011
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Microcirculation During Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT01425931
- Acronym / sponsor ID
- O2C-001AHK
- Conditions
- MeSH Heading Cardiac Surgical Procedures, Tree Number E04.100.376, Tree Number E04.928.220
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 30 Aug 2011 (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.
O2C is a diagnostic device for non-invasive determination of oxygen supply in microcirculation of blood perfused tissues. The optical sensor is easy to handle and guarantees reproducible examinations of local oxygen supply of tissues in clinics as well as in research. The examinations are without any strain for your patient.
Determines by use of a glass fibre probe:
Blood Flow in Microcirculation Capillary-Venous Oxygen Saturation Blood Filling of Microvessels Blood Flow Velocity This device makes it possible to supervise the local oxygen supply of organs and tissue.
With it is possible to measure locally the amount of oxygen which is transported into the region of interest and to diagnose local oxygen consumption of an organ. O2C's novelty is monitoring the energetic metabolism of cells by measuring the oxygen uptake with an optical sensor probe. Pathological O2-supply, which can lead to angiogenesis or cell-death and subsequently to organ failure, now can be detected in an early state by use of the new sensor system.
One of these new developed sensors are used to place in rectal position during extracorporeal circulation to determine the microcirculation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal circulation | – | Procedure: Heart Lung machineall patients were measured by microcirculation device O2C |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac surgery patients with ecc
Key inclusion criteria (1 listed)
- Patients on extracorporeal circulation
Key exclusion criteria (1 listed)
- Haemorrhoidal lesions
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 |
|---|---|---|
| Heart Lung machinemeasurement of microcirculation with O2C device | Procedure or surgery | Extracorporeal circulation |
Primary outcome
Blood Flow in Microcirculation
Time frame: 3 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 6 Aug 2014.
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 MeSH Heading Cardiac Surgical Procedures and Tree Number E04.100.376, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 6 Aug 2014. 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 Germany. 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?
Blood Flow in Microcirculation (time frame: 3 hours). 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 6 Aug 2014.