Refeeding Syndrome Among Older Adults

NCT03141489 | Completed DMC

• 1 other identifier: 2017/FO148295
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Hand grip strength

  Using Jamar Pluss Digital +, Measuring change in kg from baseline, day 4, 7 and at 3months.

  Baseline and at three months.

Secondary Outcomes (8)

• EQ-5D-5L

  Day 4 and after 3 months

• Alertness, attention, acute change, and abbreviated mental test (The 4AT),

  Day 4 and after 3 months

• Mortality

  register mortality after 3 months and 1-year

• Readmission rates

  Readmissionrates after 30 days

• Weight measurement

  Day 1, day 4 and on day 7 after staring with tubefeeding in hospital, and at 3 months

Study Arms (2)

NICE guidelines for refeeding syndrome

EXPERIMENTAL

High protein enteral tubefeeding solution. 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.

Dietary Supplement: Tubefeeding

Diakonhjemmet Hospital Protocol(DS)

EXPERIMENTAL

High protein enteral tubefeeding solution. The intervention group, Diakonhjemmets feeding protocol, will start at 20 calories a kg a day, and increasing until estimated needs are met within 3days

Dietary Supplement: Tubefeeding

Interventions

Tubefeeding DIETARY_SUPPLEMENT

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.

Also known as: fed by a feeding tube

Diakonhjemmet Hospital Protocol(DS); NICE guidelines for refeeding syndrome

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe dementia (palliative stage).
• 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.

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead
• Norwegian Health Association: collaborator

Study Sites (1)

Diakonhjemmet Hospital

Oslo, Postboks 23 Vinderen, 0319, Norway

Location

Related Publications (1)

• Olsen SU, Tazmini K, Aas AM, Ranhoff AH, Pripp AH, Hesseberg K, Sunde S, Bye A. The incidence and mortality of refeeding syndrome in older hospitalized patients, based on three different diagnostic criteria: A longitudinal study. Clin Nutr ESPEN. 2024 Jun;61:101-107. doi: 10.1016/j.clnesp.2024.03.006. Epub 2024 Mar 15.

  PMID: 38777421 DERIVED

MeSH Terms

Conditions

Refeeding Syndrome

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Anette H Ranhoff, Professor

  Diakonhjemmet Hospital, Vinderen, Postboks 23, 0319 Oslo, Norway

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients and care provider(nurse) will be masked(not informed), Patients will be screened (height and weight) and handgrip strength will be performed by the investigator. Patients will sign a written consent, and then randomized to either the control or an intervention group. Patients will be tested on day 4, 7 and at 3 months by a research assistant/outcome assessor and is blinded treatment allocations. Blood tests are drawn daily. A nurse will administered the tubefeeding according to written orders in the medical journal; nurses are not informed about treatment allocation or the outcome measures. Physicians are informed about the study, but will not know what treatment patients will receive.
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Dietitian

Model Details: Refeeding protocol: Standardised refeeding protocols will be used for each of the patient groups; the control group will start tube feeding at 5 or 10 kcal/kg/day depending on their BMI and increase until needs are met within 7 days. The intervention group will start tube feeding at 20 kcal/kg/day and increase until needs are met within 3 days, but continue feeding minimum of 7days. Electrolytes will be monitored daily The patients will receive100 mg thiamine, and 1 multivitamin/mineral daily, all recorded in the medical journal. The intervention group will receive approximately 40% higher amount of protein and calories compared to the control group in the end of day 7.

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: May 5, 2017
• Study Start: April 10, 2017
• Primary Completion: August 6, 2019
• Study Completion: October 8, 2019
• Last Updated: September 27, 2021

Record last verified: 2021-09

Locations

NO (1)