CompletedNot Applicable

Refeeding Syndrome Among Older Adults

Norway84 participantsStarted 2017-04-10

Plain-language summary

Malnutrition is highly prevalent among older adults. Adequate treatment is crucial to maintain health, improve functional status and independency. For severely malnourished patient, tube feeding is often the most effective treatment, but it also implies a risk of developing refeeding syndrome (RFS). RFS is described as fluid and electrolyte shifts particular hypophosphatemia when recommencing nutrition, potentially causing fatal complications. In 2006 National Institute for Health and Care Excellence (NICE) developed guidelines regarding 1) detecting patients at risk for RFS and 2) a treatment plan for refeeding severely malnourished patients. These guidelines have never been validated. Hence, there is a need to explore the use of different refeeding regimens in the treatment of older malnourished patients, in regards to assess safety, as well as the impact of the treatment, on functional status, independency, quality of life and RFS. This will be the first randomized controlled trial (RCT) that challenges the existing NICE guidelines. A blinded RCT study, with the aim of tube feeding patients at risk for developing RFS, and assigned either to an intervention group or to a control group, comparing the different refeeding regimens. This study will help develop safe and validated refeeding protocols for severely malnourished older patients.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Malnourished: According to NICE screening tool: * BMI \<16kg/m2, or weight loss, or little nutritional intake, Or: BMI\< 18.5kg/m2, and; weight loss, or little nutritional intake, or alcohol, drug abuse, chemotherapy, antacids diuretics. Exclusion Criteria: * Severe dementia (palliative stage). * Severe kidney disease, or congestive heart failure NYHA class III or IV(medical doctor to decide if patient is eligible for inclusion) * Already on artificial nutrition * Terminal stage of life, defined as receiving only palliative medical treatment * Readmissions (patients will not be included twice) * Intensive care patients.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Hand grip strength

Timeframe: Baseline and at three months.

Trial details

NCT IDNCT03141489

SponsorDiakonhjemmet Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-06

View on ClinicalTrials.gov More Refeeding Syndrome trials