Urethral Perfusion IndexUPRIGHTNCT06799832
Urethral PeRfusion Index-Guided Hemodynamic ManagemenT in Patients Having Major Abdominal Surgery: the UPRIGHT Randomized Feasibility Trial
A study testing urethal perfusion index monitoring in people with Urethral Perfusion Index and Tissue Perfusion, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
Trial summary
We will perform this single-center pilot trial to determine if the intraoperative urethral perfusion index is higher in patients assigned to maintaining postinduction baseline urethral perfusion index than in patients assigned to routine care (with blinded urethral perfusion index monitoring). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Urethral Perfusion Index, Tissue Perfusion, Microcirculation
- What is being tested?
- urethal perfusion index monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesGermany
- Study dates
- 21 Jan 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 45 years old
- scheduled for elective major abdominal surgery (involving visceral organs with an expected duration of at least 120 minutes)
- indication for an arterial catheter
- indication for an urinary catheter
Who cannot join
- Pregnancy
- Planned surgery: nephrectomy, liver or kidney transplantation surgery
- Patients who previously had surgery on the urethra or bladder
- Patients without clinical indication for continuous blood pressure monitoring with an intraarterial catheter
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Not yet recruiting
University Medical Center Hamburg-Eppendorf
Hamburg
Bernd Saugel, MD, +49 (0) 40 7410 - 52415, b.saugel@uke.de
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg
About this study
We will perform this single-center pilot trial to determine if the intraoperative urethral perfusion index is higher in patients assigned to maintaining postinduction baseline urethral perfusion index than in patients assigned to routine care (with blinded urethral perfusion index monitoring). As pre-planned substudies, we will also assess the agreement between a) urethral perfusion index-derived pulse rate and heart rate measured with an electrocardiogram and b) between the urethral perfusion index and the peripheral perfusion index.
- Conditions
- Urethral Perfusion Index, Tissue Perfusion, Microcirculation
- Being tested
- urethal perfusion index monitoring
- Keywords
- urethral perfusion index, tissue perfusion, microcirculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urethal perfusion index monitoringDevice
The urethral perfusion index will be monitored using the IKORUS System (Vygon, Écouen, France)
| Study group | Role | What they receive |
|---|---|---|
| Routine hemodynamic management | No intervention | In patients assigned to routine hemodynamic management, hemodynamic management will be performed according to routine care. The urethral perfusion index measurements will not be visible. |
| Urethral perfusion index guided hemodynamic monitoring | Experimental | In patients assigned to urethral perfusion index-guided hemodynamic monitoring, clinicians will be asked to maintaining the intraoperative urethral perfusion index above the postinduction baseline urethral perfusion index during surgery. Interventions to maintain intraoperative urethral perfusion index will be at the clinicians' discretion. All other medical procedures will be performed according to routine care. Clinical judgement will always prevail. Additionally, we will always strive to maintain macrocirculatory variables within predefined safety ranges: Mean arterial pressure: 60 mmHg - 120 mmHg Heart rate: 30 bpm - 120 bpm Cardiac index: at least 2.2 L/min/m2 Receives: Device: urethal perfusion index monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
average intraoperative urethral perfusion index
Measured: Start of surgery until end of surgery
Secondary outcomes (7)
the absolute lowest intraoperative urethral perfusion index
Measured: Start of surgery until end of surgery
the lowest intraoperative 5-minute moving average urethral perfusion index
Measured: Start of surgery until end of surgery
the intraoperative area under the baseline urethral perfusion index
Measured: Start of surgery until end of surgery
the cumulative intraoperative duration with a urethral perfusion index below the baseline urethral perfusion index
Measured: Start of surgery until end of surgery
the percentage of surgical time the urethral perfusion index is above the postinduction baseline urethral perfusion index
Measured: Start of surgery until end of surgery
intraoperative area under a urethral perfusion index value 30% below baseline
Measured: Start of surgery until end of surgery
cumulative intraoperative duration with a urethral perfusion index below at least 30% lower than baseline
Measured: Start of surgery until end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start21 Jan 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urethral Perfusion IndexStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernd Saugel, MD, Principal investigator, University Medical Center Hamburg Eppendorf, Hamburg, Germany and OUTCOMES RESEARCH Consortium®, Houston, Texas, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799832
- Sponsor's protocol ID
- 2024-101408-BO-ff
- Acronym
- UPRIGHT
- Status last verified
- Feb 2025
- First submitted
- 23 Jan 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urethral PeRfusion Index-Guided Hemodynamic ManagemenT in Patients Having Major Abdominal Surgery: the UPRIGHT Randomized Feasibility Trial
- ClinicalTrials.gov ID
- NCT06799832
- Acronym / sponsor ID
- UPRIGHT / 2024-101408-BO-ff
- Conditions
- Urethral Perfusion Index, Tissue Perfusion, Microcirculation
- Keywords
- urethral perfusion index, tissue perfusion, microcirculation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 29 Jan 2025 (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.
We will perform this single-center pilot trial to determine if the intraoperative urethral perfusion index is higher in patients assigned to maintaining postinduction baseline urethral perfusion index than in patients assigned to routine care (with blinded urethral perfusion index monitoring). As pre-planned substudies, we will also assess the agreement between a) urethral perfusion index-derived pulse rate and heart rate measured with an electrocardiogram and b) between the urethral perfusion index and the peripheral perfusion index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine hemodynamic management | No intervention | –In patients assigned to routine hemodynamic management, hemodynamic management will be performed according to routine care. The urethral perfusion index measurements will not be visible. |
| Urethral perfusion index guided hemodynamic monitoring | Experimental | Device: urethal perfusion index monitoringIn patients assigned to urethral perfusion index-guided hemodynamic monitoring, clinicians will be asked to maintaining the intraoperative urethral perfusion index above the postinduction baseline urethral perfusion index during surgery. Interventions to maintain intraoperative urethral perfusion index will be at the clinicians' discretion. All other medical procedures will be performed according to routine care. Clinical judgement will always prevail. Additionally, we will always strive to maintain macrocirculatory variables within predefined safety ranges: Mean arterial pressure: 60 mmHg - 120 mmHg Heart rate: 30 bpm - 120 bpm Cardiac index: at least 2.2 L/min/m2 |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 45 years old
- scheduled for elective major abdominal surgery (involving visceral organs with an expected duration of at least 120 minutes)
- indication for an arterial catheter
- indication for an urinary catheter
Key exclusion criteria (4 listed)
- Pregnancy
- Planned surgery: nephrectomy, liver or kidney transplantation surgery
- Patients who previously had surgery on the urethra or bladder
- Patients without clinical indication for continuous blood pressure monitoring with an intraarterial 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 |
|---|---|---|
| urethal perfusion index monitoringThe urethral perfusion index will be monitored using the IKORUS System (Vygon, Écouen, France) | Device | Urethral perfusion index guided hemodynamic monitoring |
Primary outcome
average intraoperative urethral perfusion index
Time frame: Start of surgery until end of surgery
7 secondary outcomes
the absolute lowest intraoperative urethral perfusion index
Time frame: Start of surgery until end of surgery
the lowest intraoperative 5-minute moving average urethral perfusion index
Time frame: Start of surgery until end of surgery
the intraoperative area under the baseline urethral perfusion index
Time frame: Start of surgery until end of surgery
the cumulative intraoperative duration with a urethral perfusion index below the baseline urethral perfusion index
Time frame: Start of surgery until end of surgery
the percentage of surgical time the urethral perfusion index is above the postinduction baseline urethral perfusion index
Time frame: Start of surgery until end of surgery
intraoperative area under a urethral perfusion index value 30% below baseline
Time frame: Start of surgery until end of surgery
cumulative intraoperative duration with a urethral perfusion index below at least 30% lower than baseline
Time frame: Start of surgery until end of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
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.
Bernd Saugel, MD principal investigator
University Medical Center Hamburg Eppendorf, Hamburg, Germany and OUTCOMES RESEARCH Consortium®, Houston, Texas, USA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urethal perfusion index monitoring in people with Urethral Perfusion Index and Tissue Perfusion, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernd Saugel, MD (+49741052415, b.saugel@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average intraoperative urethral perfusion index (time frame: Start of surgery until end of surgery). 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 21 Feb 2025.