RecruitingOBSERVATIONAL

Association Between Renal Regional Oxygen Saturation Measured by Near-InfraRed Spectroscopy and Postoperative Renal Failure After Lung Transplantation Surgery: A Pilot Study

This study looks at preventing kidney problems, which are common after lung transplant surgery. We know that up to half of patients can develop kidney issues, sometimes needing extra support like dialysis. Doctors believe that some problems during surgery, such as low oxygen to the kidneys, might lead to these issues. This study uses a new monitoring device, called Near-Infrared Spectroscopy (NIRS), to non-invasively measure oxygen levels in the kidneys during the lung transplant operation. The goal is to find out if this monitor can reliably predict which patients might develop kidney failure afterwards. If successful, this tool could help surgical teams make real-time adjustments to protect patients' kidneys during surgery.

At a glance

Status

Recruiting

Sponsor

Assistance Publique Hopitaux De Marseille

Enrolment target

Start

23 Mar 2024

Estimated completion

28 Sep 2026

Lung Transplant; Complications Acute Kidney Injury

What is this study about?

Lung transplant operations are life-saving, but they can sometimes lead to complications, with kidney issues being quite common. Unfortunately, more than half of people who have a lung transplant can experience kidney problems afterwards, and some even need temporary kidney support like dialysis – a treatment that cleans the blood when kidneys aren't working properly. We know that many things can contribute to these kidney problems, including factors before, during, and after the surgery.

Doctors believe that what happens during the actual operation, such as changes in blood flow, significant bleeding, or low oxygen levels, might play a big part in damaging the kidneys. Currently, there isn't a reliable tool that doctors can use during surgery to check if the kidneys are getting enough oxygen or to guide them on how to protect the kidneys better. This study wants to change that. It's investigating if a special monitoring device, called Near-Infrared Spectroscopy (NIRS), can help.

NIRS is a clever bit of technology that shines light into the body to measure how much oxygen is in the tissues, without needing any cuts or needles. It's already used to check brain oxygen levels in some surgeries. This study plans to use NIRS to monitor oxygen levels specifically in the kidneys during lung transplant surgery. The main aim is to see if these measurements can accurately predict which patients are likely to develop kidney failure after their operation. If this monitor works well, it could give surgeons vital information in real-time, allowing them to make adjustments during surgery to better protect a patient's kidneys and hopefully reduce serious complications.

Key takeaways

Kidney problems are common after lung transplants.
This study uses a non-invasive monitor (NIRS) to check kidney oxygen levels during surgery.
The goal is to see if NIRS can predict and potentially help prevent kidney failure.
Participation involves monitoring only during the planned surgery.
The study aims to improve care for future lung transplant patients.

Who may be eligible?

To be considered for this study, you would need to be an adult (18 years or older) and be scheduled to have a lung transplant operation. You also need to be part of the French social security system.

There are certain reasons why you wouldn't be able to join the study. These include having kidney conditions that would make the monitor's readings unreliable, such as having only one kidney or a condition called polycystic kidney disease. Also, if you already have very high levels of a substance called bilirubin in your blood, or if you're already on a heart-lung bypass machine (ECMO) or a breathing machine (mechanical ventilation) before your surgery, you wouldn't be able to participate. Lastly, if you simply don't wish to be part of the research, that's perfectly fine.

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 18 years old or older?
Are you scheduled for a lung transplant (single or double)?
Do you have typical kidney anatomy (not just one kidney or polycystic kidney disease)?
Are you NOT currently on a heart-lung bypass machine (ECMO) or mechanical ventilation before surgery?
Do you consent to participate in research?

Answer every question to see your result.

What does participation involve?

This study involves monitoring. There are no new medications or extra procedures for you. If you participate, a special monitor will be placed on your skin over your kidneys during your lung transplant surgery. This monitor uses light to non-invasively measure the oxygen levels in your kidneys throughout the operation. There will be no extra hospital visits or follow-up appointments specifically for this study. The researchers will simply collect data from this monitor during your planned surgery and then track your kidney health as part of your standard post-operative care. Your total involvement in terms of new procedures or appointments is limited to the monitoring during your surgery.

Potential risks and benefits

Participating in this study might not offer direct health benefits to you personally, as it's primarily about gathering information. However, the information gained could significantly help future patients undergoing lung transplants by improving kidney protection during surgery. The risks associated with the NIRS monitor are minimal; it's a non-invasive device placed on the skin and doesn't involve needles or surgery. The main consideration is that the device might be a slight inconvenience during the preparation for surgery, but it does not cause pain or interfere with the operation. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Service d'anesthésie et réanimation adulte
Verified postcode
Marseille, France· Recruiting

Common questions

What is a 'lung transplant'?

A lung transplant is a major operation where a person's diseased or damaged lung is replaced with a healthy lung from a donor.

What are 'kidney problems' after surgery?

After some surgeries, the kidneys might not work as well as they should, which is called acute kidney injury or kidney failure. It can be temporary.

What is NIRS?

NIRS (Near-Infrared Spectroscopy) is a special monitor that uses light to harmlessly check how much oxygen is in your body's tissues, like your kidneys.

Will this monitor hurt?

No, the NIRS monitor is placed on your skin and does not hurt. It's similar to sensors used to check oxygen in your finger.

Why is it important to prevent kidney problems?

Keeping kidneys healthy after surgery is vital for a good recovery and overall long-term health.

How to find out more

Pierre Mora

pierre.mora@ap-hm.fr 0491965537 Official trial record

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