High-risk Surgical PatientsSTEP UPNCT03410069
Monitoring Tissue Perfusion in Critically Ill or High-risk Surgical Patients
A study testing IKORUS UP system in people with High-risk Surgical Patients, run by Advanced Perfusion Diagnostics at 4 sites in France.
Trial summary
Circulatory shock is defined as an imbalance between oxygen supply and/or impaired oxygen use to maintain organ function. With growing evidence of lack of correlation between macro- and micro-circulation, use of "Whole Body" markers such as blood pressure (BP) or Lactates are often insufficient to assess the severity… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-risk Surgical Patients
- What is being tested?
- IKORUS UP system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesFrance
- Study dates
- 3 Aug 2018to 7 May 2019
- Phase
- Interventional
- 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
- 18 years of age or more,
- Male or female,
- High-Risk surgical patient,
- Life expectancy expected to exceed 72 hours,
- Willing to participate and signed informed consent,
- Affiliation to the French social security system.
Show all 13Show fewer
- Non inclusion criteria:
- Pregnant or lactating woman,
- History of recent urological surgery (bladder surgery, prostate surgery…),
- Known stricture or "impossible insertion" last hospitalization,
- Traumatic injury to the lower urinary tract,
- History of radiotherapy of pelvic or genital area,
- Genital malformation (Hypospadias…).
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Estaing
Clermont-Ferrand, 63003
Lyon Sud Hospital
Lyon, 69310
Hopital Nord Marseille
Marseille, 13015
Hospital Saint Louis
Paris
About this study
Official title: Monitoring Tissue Perfusion in Critically Ill or High-risk Surgical Patients: a Pilot Clinical Study To Evaluate the aPplicability and the Safety of Urethral Perfusion Measurement With the IKORUS System
Circulatory shock is defined as an imbalance between oxygen supply and/or impaired oxygen use to maintain organ function. With growing evidence of lack of correlation between macro- and micro-circulation, use of "Whole Body" markers such as blood pressure (BP) or Lactates are often insufficient to assess the severity of the oxygen debt and/or tissue hypoperfusion. Thus, an approach incorporating tissue-perfusion based endpoints would represent a significant step up to guide optimal resuscitation of critically-ill patients and to reduce complications in high-risk surgery.
Current monitoring techniques, that complement systemic hemodynamics by focusing on regional perfusion, still lack the required user-friendliness and/or clinical relevance to be routinely used at bedside. Therefore, assessment of the adequacy of tissue perfusion and oxygenation is suboptimal, and implementation of the above-mentioned approaches of resuscitation is still a challenge.
Read more
Urethral perfusion is likely to be early and significantly impaired during low-flow states and thus represents a good "candidate" as a surrogate site to assess the perfusion of visceral organs. Besides, urethral mucosa can be investigated in a less invasive and simpler manner than "deeper" organs. Nowadays, no practical methods or devices are available to monitor perfusion in the pelvic area. Thus, recent development of a new monitoring device of urethral perfusion could fill this need and enable enhanced management of patients in Intensive Care Units (ICU) and Operating Rooms (OR).
The device consists of a modified Foley catheter equipped with a photoplethysmographic sensor: the IKORUS UP probe.
The probe will be used by intensivists or anesthesiologists on high-risk surgical patients, i.e. patients with comorbidities undergoing major vascular, thoracic and/or abdominal surgery.
- Conditions
- High-risk Surgical Patients
- Being tested
- IKORUS UP system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IKORUS UP systemDevice
Continuous assessment of the urethral microcirculation
| Study group | Role | What they receive |
|---|---|---|
| IKORUS UP | Experimental | Not described Receives: Device: IKORUS UP system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications
Complications rate: Injury during insertion; Bleeding; Infection; Pain; Discomfort.
Measured: 28 days
Secondary outcomes (12)
Applicability of the procedure
Evaluation of applicability (compared to a standard Foley catheter): questionnaire for the nurse and/or the physician.
Measured: 28 days
Signal acquisition
Duration of useable signal acquisition (duration of perfusion index computation)
Measured: 28 days
Effect of the position of the sensor
Quality of signal according to sensor position (proximal/distal)
Measured: 28 days
Quality of the signal
Assessment of signal Quality, including Signal-to-noise ratio
Measured: 28 days
Evolution of mean arterial pressure
Measures of hemodynamic /metabolic parameters: mean arterial pressure (MAP)
Measured: 28 days
Evolution of SpO2
Measures of hemodynamic /metabolic parameters: SpO2
Measured: 28 days
Evolution of SVO2
Measures of hemodynamic /metabolic parameters: SVO2
Measured: 28 days
Evolution of lactates dosages
Measures of hemodynamic /metabolic parameters: lactactes
Measured: 28 days
Evolution of cardiac outputs
Measures of hemodynamic /metabolic parameters: cardiac output
Measured: 28 days
Evolution of central venous pressure
Measures of hemodynamic /metabolic parameters: central venous pressure (CVP)
Measured: 28 days
Evolution of catecholamine infusions levels
Measures of hemodynamic /metabolic parameters: catecholamine infusions levels
Measured: 28 days
Rate of resuscitation events
Measures of hemodynamic or metabolic parameters: resuscitation events
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start3 Aug 2018
- Primary completion7 May 2019
- Study completion7 May 2019
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 High-risk Surgical PatientsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Perfusion Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CEISO
- Responsible party
- Sponsor
- Investigators
- Bernard Allaouchiche, Prof, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410069
- Sponsor's protocol ID
- 2017-A03466-47
- Acronym
- STEP UP
- Status last verified
- May 2019
- First submitted
- 12 Jan 2018
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Depret F, Leone M, Duclos G, Futier E, Montagne M, Legrand M, Allaouchiche B. Monitoring tissue perfusion: a pilot clinical feasibility and safety study of a urethral photoplethysmography-derived perfusion device in high-risk patients. J Clin Monit Comput. 2020 Oct;34(5):961-969. doi: 10.1007/s10877-019-00414-9. Epub 2019 Nov 6.
PubMed 31691897
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Tissue Perfusion in Critically Ill or High-risk Surgical Patients: a Pilot Clinical Study To Evaluate the aPplicability and the Safety of Urethral Perfusion Measurement With the IKORUS System
- ClinicalTrials.gov ID
- NCT03410069
- Acronym / sponsor ID
- STEP UP / 2017-A03466-47
- Conditions
- High-risk Surgical Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Advanced Perfusion DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- CEISO
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 25 Jan 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.
Circulatory shock is defined as an imbalance between oxygen supply and/or impaired oxygen use to maintain organ function. With growing evidence of lack of correlation between macro- and micro-circulation, use of "Whole Body" markers such as blood pressure (BP) or Lactates are often insufficient to assess the severity of the oxygen debt and/or tissue hypoperfusion. Thus, an approach incorporating tissue-perfusion based endpoints would represent a significant step up to guide optimal resuscitation of critically-ill patients and to reduce complications in high-risk surgery.
Current monitoring techniques, that complement systemic hemodynamics by focusing on regional perfusion, still lack the required user-friendliness and/or clinical relevance to be routinely used at bedside. Therefore, assessment of the adequacy of tissue perfusion and oxygenation is suboptimal, and implementation of the above-mentioned approaches of resuscitation is still a challenge.
Urethral perfusion is likely to be early and significantly impaired during low-flow states and thus represents a good "candidate" as a surrogate site to assess the perfusion of visceral organs. Besides, urethral mucosa can be investigated in a less invasive and simpler manner than "deeper" organs. Nowadays, no practical methods or devices are available to monitor perfusion in the pelvic area. Thus, recent development of a new monitoring device of urethral perfusion could fill this need and enable enhanced management of patients in Intensive Care Units (ICU) and Operating Rooms (OR).
The device consists of a modified Foley catheter equipped with a photoplethysmographic sensor: the IKORUS UP probe.
The probe will be used by intensivists or anesthesiologists on high-risk surgical patients, i.e. patients with comorbidities undergoing major vascular, thoracic and/or abdominal surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IKORUS UP | Experimental | Device: IKORUS UP system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 years of age or more,
- Male or female,
- High-Risk surgical patient,
- Life expectancy expected to exceed 72 hours,
- Willing to participate and signed informed consent,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| IKORUS UP systemContinuous assessment of the urethral microcirculation | Device | IKORUS UP |
Primary outcome
Incidence of complications
Time frame: 28 days
Complications rate: Injury during insertion; Bleeding; Infection; Pain; Discomfort.
12 secondary outcomes
Applicability of the procedure
Time frame: 28 days
Signal acquisition
Time frame: 28 days
Effect of the position of the sensor
Time frame: 28 days
Quality of the signal
Time frame: 28 days
Evolution of mean arterial pressure
Time frame: 28 days
Evolution of SpO2
Time frame: 28 days
Evolution of SVO2
Time frame: 28 days
Evolution of lactates dosages
Time frame: 28 days
Evolution of cardiac outputs
Time frame: 28 days
Evolution of central venous pressure
Time frame: 28 days
Evolution of catecholamine infusions levels
Time frame: 28 days
Rate of resuscitation events
Time frame: 28 days
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 20 May 2019.
- Derived from this study: PubMed 31691897Depret F, Leone M, Duclos G, Futier E, Montagne M, Legrand M, Allaouchiche B. Monitoring tissue perfusion: a pilot clinical feasibility and safety study of a urethral photoplethysmography-derived perfusion device in high-risk patients. J Clin Monit Comput. 2020 Oct;34(5):961-969. doi: 10.1007/s10877-019-00414-9. Epub 2019 Nov 6.
- Individual participant dataSharing planned: No
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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.
Bernard Allaouchiche, Prof principal investigator
Hospices Civils de Lyon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IKORUS UP system in people with High-risk Surgical Patients, run by Advanced Perfusion Diagnostics at 4 sites in France.
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 13 inclusion and 0 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 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Incidence of complications (time frame: 28 days). 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 NCT03410069, 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 May 2019.