Critical IllnessPhase 2/3OTO-STSNCT00167596
Near Infrared Spectroscopy (NIRS) in Severe Sepsis
A Phase 2/3 study testing Near Infrared Spectroscopy and conventional in people with Critical Illness and Severe Sepsis, run by University of Versailles at 7 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the usefulness of an optimization of muscle perfusion and oxygenation, as assessed by the NIRS technique, in critically ill patients with sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Severe Sepsis
- What is being tested?
- Near Infrared Spectroscopy and conventional
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Jul 2005to Dec 2009
- Phase
- Phase 2/3
- 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
Who may be able to join
- Two of four criteria for the systemic inflammatory response syndrome; and one of the following:
- systolic blood pressure =< 90 mm Hg; or
- a blood lactate concentration => 4 mmol/l; or
- skin marbling; or
- impaired consciousness; or
- urine output < 30 ml/h.
Who cannot join
- Age < 18 years
- Pregnancy
- Do-not-resuscitate status
- Advanced directives restricting implementation of the protocol
- Obesity (body mass index [BMI] > 30)
- Anasarca
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
France3 sites
Raymond Poincaré Hospital
Garches, 92380
Hôpital Nord AP HM
Marseille, 13
CHU Tours
Tours
Germany2 sites
GERLACH Herwig
Berlin
University Hospital Rostock
Rostock, 18057
About this study
Official title: Phase III Study of Usefulness of Near Infrared Spectroscopy to Optimize Tissues Perfusion and Oxygenation in Severe Sepsis
The purpose of this study is to evaluate the usefulness of an optimization of muscle perfusion and oxygenation, as assessed by the NIRS technique, in critically ill patients with sepsis.
Read the detailed description
The systemic inflammatory response to sepsis may cause impaired tissue oxygenation that can persist despite the restoration of a normal hemodynamic profile and systemic oxygen transport.
Therefore, the assessment of tissue oxygenation and perfusion is recommended in patients with severe sepsis.
The InSpectra tissue spectrometer relies on continuous wave near infrared (NIR) technology to estimate non invasively local tissue hemoglobin oxygen saturation in tissue (% StO2). This technology had been tested in a variety of systems: standard theoretical models of light transport, isolated blood, isolated blood-perfused animal organs and healthy human volunteers with induced limb ischemia. In critical-care medicine, NIRS has also been used to evaluate muscle oxygenation in trauma resuscitation and in lower extremity and abdominal compartment syndrome. However, NIRS has been rarely utilised to measure tissue blood flow and oxygen uptake in critically ill patients.
- Conditions
- Critical Illness, Severe Sepsis
- Being tested
- Near Infrared Spectroscopy, conventional
- Keywords
- near infrared spectroscopy, tissue oxygenation, organ dysfunction, mortality
- Medical subject headings
- Critical Illness, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared SpectroscopyDevice
resuscitation will be based on Surviving Sepsis Campaign guidelines AND on increasing StO2 to 80% or more in at least 2 out of the 3 following sites: thenar, masseter and deltoid
conventionalDevice
resuscitation will be based according to Surviving Sepsis Campaign
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Early goal directed therapy based on StO2 evaluation Receives: Device: Near Infrared Spectroscopy |
| 2 | Active comparator | Early goal directed therapy Receives: Device: conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
A combined endpoint of mortality and sequential organ failure assessment (SOFA) score increase at day 7 is the primary efficacy endpoint
Measured: Day 7
Secondary outcomes (2)
duration of mechanical ventilation
Measured: from randomization to Day 28
length of the hospital stay
Measured: from randomization to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionMay 2009
- Study completionDec 2009
Why it stopped: recruitment was stopped as consequence of cessation of funding (economic crisis)
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 Critical IllnessStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Versailles
- Sponsor type
- University, hospital or other
- Collaborators
- Hutchinson Technology Inc, Assistance Publique - Hôpitaux de Paris
- Responsible party
- Principal investigator, Djillali Annane, University of Versailles
- Investigators
- Djillali Annane, MD, PhD, Study chair, Raymond Poincaré Hospital, AP-HPOlivier Nardi, MD, Study director, Raymond Poincaré Hospital, AP-HPGwenhael Colin, MD, Principal investigator, Raymond Poincaré Hospital, AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167596
- Sponsor's protocol ID
- 05008
- Acronym
- OTO-STS
- Status last verified
- Jul 2016
- First submitted
- 9 Sep 2005
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nardi O, Zavala E, Martin C, Nanas S, Scheeren T, Polito A, Borrat X, Annane D. Targeting skeletal muscle tissue oxygenation (StO2) in adults with severe sepsis and septic shock: a randomised controlled trial (OTO-StS Study). BMJ Open. 2018 Mar 19;8(3):e017581. doi: 10.1136/bmjopen-2017-017581.
PubMed 29555789
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Usefulness of Near Infrared Spectroscopy to Optimize Tissues Perfusion and Oxygenation in Severe Sepsis
- ClinicalTrials.gov ID
- NCT00167596
- Acronym / sponsor ID
- OTO-STS / 05008
- Conditions
- Critical Illness, Severe Sepsis
- Keywords
- near infrared spectroscopy, tissue oxygenation, organ dysfunction, mortality
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment was stopped as consequence of cessation of funding (economic crisis)
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of VersaillesUniversity, hospital or other
- Collaborators
- Hutchinson Technology Inc, Assistance Publique - Hôpitaux de Paris
- Study start
- Jul 2005
- Primary completion
- May 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 Sep 2005 (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 purpose of this study is to evaluate the usefulness of an optimization of muscle perfusion and oxygenation, as assessed by the NIRS technique, in critically ill patients with sepsis.
Detailed description
The systemic inflammatory response to sepsis may cause impaired tissue oxygenation that can persist despite the restoration of a normal hemodynamic profile and systemic oxygen transport.
Therefore, the assessment of tissue oxygenation and perfusion is recommended in patients with severe sepsis.
The InSpectra tissue spectrometer relies on continuous wave near infrared (NIR) technology to estimate non invasively local tissue hemoglobin oxygen saturation in tissue (% StO2). This technology had been tested in a variety of systems: standard theoretical models of light transport, isolated blood, isolated blood-perfused animal organs and healthy human volunteers with induced limb ischemia. In critical-care medicine, NIRS has also been used to evaluate muscle oxygenation in trauma resuscitation and in lower extremity and abdominal compartment syndrome. However, NIRS has been rarely utilised to measure tissue blood flow and oxygen uptake in critically ill patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Near Infrared SpectroscopyEarly goal directed therapy based on StO2 evaluation |
| 2 | Active comparator | Device: conventionalEarly goal directed therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Two of four criteria for the systemic inflammatory response syndrome; and one of the following:
Key exclusion criteria (6 listed)
- Age < 18 years
- Pregnancy
- Do-not-resuscitate status
- Advanced directives restricting implementation of the protocol
- Obesity (body mass index [BMI] > 30)
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 |
|---|---|---|
| Near Infrared Spectroscopyresuscitation will be based on Surviving Sepsis Campaign guidelines AND on increasing StO2 to 80% or more in at least 2 out of the 3 following sites: thenar, masseter and deltoid | Device | 1 |
| conventionalresuscitation will be based according to Surviving Sepsis Campaign | Device | 2 |
Primary outcome
A combined endpoint of mortality and sequential organ failure assessment (SOFA) score increase at day 7 is the primary efficacy endpoint
Time frame: Day 7
2 secondary outcomes
duration of mechanical ventilation
Time frame: from randomization to Day 28
length of the hospital stay
Time frame: from randomization to Day 90
Results and safety
The study was stopped early (reason given: recruitment was stopped as consequence of cessation of funding (economic crisis)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Derived from this study: PubMed 29555789Nardi O, Zavala E, Martin C, Nanas S, Scheeren T, Polito A, Borrat X, Annane D. Targeting skeletal muscle tissue oxygenation (StO2) in adults with severe sepsis and septic shock: a randomised controlled trial (OTO-StS Study). BMJ Open. 2018 Mar 19;8(3):e017581. doi: 10.1136/bmjopen-2017-017581.
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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.
Djillali Annane, MD, PhD study chair
Raymond Poincaré Hospital, AP-HP
Olivier Nardi, MD study director
Raymond Poincaré Hospital, AP-HP
Gwenhael Colin, MD principal investigator
Raymond Poincaré Hospital, AP-HP
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Near Infrared Spectroscopy and conventional in people with Critical Illness and Severe Sepsis, run by University of Versailles at 7 sites in 4 countries.
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 6 inclusion and 6 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 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Germany, Greece, Spain. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: recruitment was stopped as consequence of cessation of funding (economic crisis)). 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?
A combined endpoint of mortality and sequential organ failure assessment (SOFA) score increase at day 7 is the primary efficacy endpoint (time frame: Day 7). 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 NCT00167596, 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 20 Jul 2016.