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Refeeding Syndrome Among Older Adults

NCT03141489 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-09-27

No results posted yet for this study

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.

Conditions

  • Refeeding Syndrome

Interventions

DIETARY_SUPPLEMENT

Tubefeeding

NICE guidelines regarding refeeding syndrome, based on a very cautious refeeding regime reaching estimated calorie and protein needs within 7 days, compared to a protocol at Diakonhjemmet Hospital using a higher starting rate, reaching estimated needs within 3 days.

Sponsors & Collaborators

  • Norwegian Health Association

    collaborator OTHER

  • Diakonhjemmet Hospital

    lead OTHER

Principal Investigators

  • Anette H Ranhoff, Professor · Diakonhjemmet Hospital, Vinderen, Postboks 23, 0319 Oslo, Norway

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2019-08-06
Completion
2019-10-08

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03141489 on ClinicalTrials.gov