RecruitingNAINTERVENTIONAL

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

This research is a pilot study designed to see if a new monitoring technique can improve care during major tummy (abdominal) surgery. The study focuses on something called the 'urethral perfusion index', which measures blood flow in a specific part of the body. During surgery, some patients will have their blood flow in this area carefully kept at a steady level, while others will receive standard care, but with this new monitor running in the background. The main goal is to find out if keeping this blood flow stable makes a difference. Researchers will also check how well this new monitor's readings match up with other ways of measuring heart rate and blood flow in the fingers. It's for people aged 45 and over who are having long operations on their internal organs.

At a glance

Status

Recruiting

Phase

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrolment target

116

Start

21 Jan 2025

Estimated completion

31 Jul 2025

Urethral Perfusion Index Tissue Perfusion Microcirculation

What is this study about?

Imagine you're having an important operation on your tummy, like surgery on your stomach or intestines. During these surgeries, it's really important that all your body's tissues, right down to the smallest blood vessels, get enough oxygen and nutrients. This is called 'tissue perfusion' or 'microcirculation'. If blood flow isn't quite right, it could affect how well you recover.

This study is testing a new way to monitor this very important blood flow. It uses a device that measures something called the 'urethral perfusion index', which basically tells doctors about the blood flow in a specific area – the tube that carries pee out of your body. Doctors want to see if actively trying to keep this blood flow stable during surgery, guided by the new monitor, can lead to better outcomes for patients compared to current standard care.

This is a 'feasibility trial', which means it's a small, initial study. It's designed to see if this new monitoring method is practical and if it shows promise. It's not about finding a cure, but about seeing if a new approach to managing blood flow during surgery might be helpful in the future. The results will help doctors decide if a larger study is needed.

Key takeaways

This study evaluates a new blood flow monitoring method during major tummy surgery.
It aims to see if keeping blood flow stable using this monitor improves patient care.
Participation involves having an extra monitor during your planned surgery, with no extra visits.
You must be 45 or older and having a long major abdominal surgery to be eligible.
This is a small first study to check if the new technique is practical and promising.

Who may be eligible?

To be able to join this study, you need to be at least 45 years old. You also need to be having a big operation on your tummy (abdomen) that will last for at least two hours. This kind of surgery usually involves organs like your stomach, intestines, or other internal organs.

Because of the monitoring involved, you'll need to already be scheduled for two specific medical devices during your surgery. One is a special tube put into an artery to continuously check your blood pressure, and the other is a tube (catheter) to drain urine from your bladder. Your doctor would decide if you need these for your surgery anyway.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant, or if your planned surgery is for a kidney removal or a liver or kidney transplant. Also, if you've had surgery on your urethra or bladder before, or if your doctor doesn't think you need continuous blood pressure monitoring with an arterial line, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 45 years old or older?
Are you having a big operation on your tummy (abdomen) that will last at least two hours?
Are you already scheduled to have an arterial line and a urinary catheter for your surgery?
Are you NOT pregnant?
Is your surgery NOT a kidney removal or a liver/kidney transplant?
Have you NOT had surgery on your urethra or bladder before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main part of your involvement will happen during your surgery. You will be randomly put into one of two groups. One group will have the new blood flow monitoring device used to help guide how your medical team manages your care during the operation. The other group will also have the monitor in place, but the medical team looking after you won't see its readings, so you'll receive standard care.

The monitoring is done using a small, soft probe that is placed in the urethra (the tube that carries urine out of your body). This doesn't involve any extra medication just for the study. After your surgery, the research team will collect information that is normally recorded as part of your hospital stay, such as how you recover. There are no additional visits, tests, or follow-up appointments required just for the study once you leave the hospital. Your total involvement effectively ends after your hospital stay.

Potential risks and benefits

Participating in this study might offer some potential benefits, as the group receiving guided care could potentially have more stable blood flow during their surgery. However, this is a pilot study, so we don't know for sure if it will improve your recovery compared to standard care. There are no known significant additional risks from having the monitoring device as it's a non-invasive probe, but any medical procedure carries some risks, and your doctor will discuss these with you. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

University Medical Center Hamburg-Eppendorf
Verified postcode
Hamburg, Germany· Not yet recruiting
University Medical Center Hamburg-Eppendorf
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What is 'urethral perfusion index'?

It's a measurement that tells doctors about the blood flow in the tube that carries pee out of your body. It helps understand how well oxygen is getting to your tissues.

Will I know if I'm getting the new monitoring or standard care?

No, you won't know which group you're in. This helps make sure the results are fair and unbiased.

Does this study involve new medicines?

No, this study is about how doctors monitor blood flow during surgery, not about new medicines.

What kind of abdominal surgery is included?

Major surgeries on internal organs like your stomach, intestines, liver (but not transplants), or pancreas that are expected to last at least two hours.

Will taking part affect my surgery outcome?

The study aims to see if this new monitoring can help. However, as it's a pilot study, we can't guarantee any specific outcome related to your recovery. Your medical team will always provide the best care for you.

How to find out more

Bernd Saugel, MD

b.saugel@uke.de +49741052415 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.