RecruitingNAINTERVENTIONAL

Evaluation of the Efficiency of Intermittent Enteral Nutrition on Multi-organ Failure From Patients With Mechanical Ventilation in Intensive Care Unit

This study is for very sick people in intensive care who are on breathing machines because of a severe infection (sepsis). We are looking at two ways of giving them nutrition through a tube into their stomach. One way is giving food continuously throughout the day. The other way is giving food in shorter bursts, similar to a pattern called 'intermittent fasting'. The main aim is to find out if feeding them intermittently can help prevent their organs, like their kidneys or lungs, from failing. Previous research suggests this method might have benefits, and we want to see if it makes a difference for patients in the ICU.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Rouen

Enrolment target

174

Start

09 Jul 2024

Estimated completion

09 Oct 2027

Intermittent Fasting Septic Shock Organ Failure, Multiple

What is this study about?

When you're very poorly in intensive care (ICU) and need a machine to help you breathe, getting the right nutrition is crucial for your recovery. Doctors often give food directly into your stomach through a tube (called enteral nutrition). Currently, many ICUs feed patients continuously over 24 hours.

This study is exploring a different approach: feeding patients in short bursts, similar to how some people eat when they 'intermittently fast'. The idea comes from earlier research that suggests giving the body short breaks from digestion might have benefits. For example, it might help the body use energy more effectively and protect organs. We want to see if this 'intermittent' way of feeding might help prevent multiple organs from failing in patients who are very ill with a severe infection, called sepsis, and are on a breathing machine.

By comparing intermittent feeding to continuous feeding, the study hopes to find out which method is better at supporting the body's recovery and preventing complications when someone is critically ill. This information could help improve care for many patients in the future.

Key takeaways

The study compares two ways of giving nutrition to very sick patients.
It aims to see if 'intermittent' feeding helps prevent organ failure.
Patients are in intensive care (ICU) with a severe infection and on a breathing machine.
Participation involves a different feeding schedule, with all other care remaining the same.
You or a family member would need to agree by signing a consent form.
Your normal medical care will not be affected by your decision to join or not join.

Who may be eligible?

To be considered for this study, you would need to be newly admitted to Intensive Care (ICU), requiring a breathing machine for at least two days, and doctors need to be able to feed you through a tube into your stomach for about a week. You also need to be receiving certain medicines to support your blood pressure. Participants must be 18 years or older, and either you or a trusted family member would need to agree to take part by signing a consent form.

There are also some reasons why you might not be able to join. For example, if you have certain problems with your food pipe that make tube feeding unsafe, or if you're already receiving tube feeding for a long time before the study starts. You also wouldn't be able to join if you need food given directly into your veins, if you're pregnant or breastfeeding, or if your doctors think you are too unwell to benefit from the study.

The study also cannot include individuals who are under guardianship or legal protection, or those who are unable to freely give their consent to participate.

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 or older?
Are you currently in an Intensive Care Unit (ICU)?
Do you need a machine to help you breathe for at least two days?
Can you receive food through a tube into your stomach?
Are you not pregnant or breastfeeding?
Are you able to agree to take part (or can a trusted family member)?
Do you not have any conditions that make tube feeding unsafe?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, the main difference in your care would be how your nutrition is given. Instead of continuous feeding through your stomach tube, doctors might give you food in short, timed sessions. Your doctors and nurses will continue to monitor your health very closely, just as they would normally in the ICU. The study would focus on the first few days of your time in the ICU. There are no additional visits or follow-up appointments outside of your standard hospital care involved for this study. The total duration of your participation in the study's feeding pattern would be determined by your medical team in the ICU.

Potential risks and benefits

Participating in this study might offer a potential benefit by helping to prevent further organ problems, based on previous research. However, there's no guarantee it will benefit you directly. When it comes to risks, it's possible that the new feeding pattern could cause some discomfort or might not be as effective for everyone. Medical staff will monitor you closely for any issues, and your safety is their priority. You, or your representative, always have the right to withdraw from the study at any time without it affecting your usual medical care.

Locations (1)

CHU de Rouen
Verified postcode
Rouen, France· Recruiting

Common questions

What is sepsis?

Sepsis is a very serious complication of an infection. It's when your body's immune system overreacts to an infection, causing inflammation throughout your body, which can lead to organ damage.

What does 'mechanical ventilation' mean?

Mechanical ventilation means you are on a machine that helps you breathe. This is often used when your lungs are too weak or sick to breathe enough on their own.

What is 'enteral nutrition'?

Enteral nutrition means getting food and nutrients through a tube directly into your stomach or small intestine. This is common when you can't eat normally, for example, if you're on a breathing machine.

What is the difference between 'intermittent' and 'continuous' feeding?

'Continuous' feeding means getting a steady flow of nutrients over many hours. 'Intermittent' feeding means getting nutrients in shorter, timed bursts, with periods of no feeding in between.

Will my care be different if I don't join the study?

No, if you don't join the study, you will still receive the best possible care, which would involve the standard method of continuous enteral feeding, or whatever your medical team deems most appropriate for you.

How to find out more

Fabienne TAMION, MD

fabienne.tamion@chu-rouen.fr +33232888261 Official trial record

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