Urethral PeRfusion Index-Guided Hemodynamic ManagemenT in Patients Having Major Abdominal Surgery: the UPRIGHT Randomized Feasibility Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-21

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Femoral Arterial Access With Ultrasound Trial

NCT00667381

Vascular Access Complications Cardiac Catheterization Peripheral Vascular Disease

COMPLETED NA

The Influence of Fluid Removal Using Continuous Venovenous Hemofiltration (CVVH) on Intra-abdominal Pressure and Kidney Function

NCT01077895

Critically Ill Intra-Abdominal Hypertension Abdominal Compartment Syndrome +1 more

WITHDRAWN PHASE3

Assessment of Ultrasound-guided Inserted Peripheral Intravenous Catheter

NCT01602133

Venous Puncture

UNKNOWN NA

Evaluation of Coagulation Factors and Point-of-care Devices During Veno-venous ECMO Therapy

NCT03754868

Extracorporeal Membrane Oxygenation Complication Coagulation Factor Deficiency

COMPLETED

TRanslesIonal Assessment of Gradients During Endovascular Therapy

NCT03163199

Peripheral Arterial Disease Fractional Flow Reserve Hemodynamics

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Urethral Perfusion Index Tissue Perfusion Microcirculation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Routine hemodynamic management

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Urethral perfusion index guided hemodynamic monitoring

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

Group Type EXPERIMENTAL

urethal perfusion index monitoring

Intervention Type DEVICE

The urethral perfusion index will be monitored using the IKORUS System (Vygon, Écouen, France)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

urethal perfusion index monitoring

The urethral perfusion index will be monitored using the IKORUS System (Vygon, Écouen, France)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No