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Refeeding Syndrome Among Older Adults (RFS)

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ClinicalTrials.gov Identifier: NCT03141489
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : July 25, 2018
Sponsor:
Collaborator:
Norwegian Health Association
Information provided by (Responsible Party):
Sissel Urke Olsen, Diakonhjemmet Hospital

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.

Condition or disease Intervention/treatment Phase
Refeeding Syndrome Dietary Supplement: Tubefeeding Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: Safe Refeeding of Severely Malnourished Patients 65 Years or Older
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NICE guidelines for refeeding syndrome
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
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.
Other Name: fed by a feeding tube

Experimental: Diakonhjemmet Hospital Protocol(DS)
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
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.
Other Name: fed by a feeding tube




Primary Outcome Measures :
  1. Change in Hand grip strength [ Time Frame: Baseline and at three months. ]
    Using Jamar Pluss Digital +, Measuring change in kg from baseline, day 4, 7 and at 3months.


Secondary Outcome Measures :
  1. EQ-5D-5L [ Time Frame: Day 4 and after 3 months ]
    Health related quality of life. Questionnaires

  2. Alertness, attention, acute change, and abbreviated mental test (The 4AT), [ Time Frame: Day 4 and after 3 months ]
    Screening instrument for cognitive impairment and delerium.

  3. Mortality [ Time Frame: register mortality after 3 months ]
    Mortalityrates during and after 3 months

  4. Readmission rates [ Time Frame: Readmissionrates after 30 days ]
    Readmission of patients in the study

  5. Weight measurement [ Time Frame: Day 1, day 4 and on day 7 after staring with tubefeeding in hospital, and at 3 months ]
    Measuring bodyweight during patients hospital stay, starting at day one of tubefeeding, and then day 4 and on day 7, and at 3 months after last tubefeeding day (with approximatly one week discrepancy)

  6. Infection [ Time Frame: Labratory values are measured daily, and assessed for infections. Baseline and day 2,3,4,5,6,7. ]
    Diagnosis set by a medical doctor. C-reactive protein (CRP), erythrocytes, sedimentation rate (ESR), white blood cells (WBC), and differential leukocyte count.

  7. Hospital length of stay (LoS) [ Time Frame: From the day of admission until the day of discharged up to 3 months. ]
    Defined as the total number of hospital days before discharge, either to a nursing home, home with homecare or home without further assistance.

  8. Number and type of complication when refeeding [ Time Frame: Number of complications on predefined refeeding day 7. ]
    Complications might be: constipation, edema, nausea and vomiting, hypoglycemia and cardiac abnormalities, and tubedislocation



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141489


Contacts
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Contact: Sissel U Olsen, MS 004747302047 sisselurke@gmail.com
Contact: Asta Bye, PhD 0047 98148822 asta.bye@hioa.no

Locations
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Norway
Diakonhjemmet Hospital Recruiting
Oslo, Postboks 23 Vinderen, Norway, 0319
Contact: Anette H Ranhoff, Professor    +47 92810198    anette.ranhoff@diakonsyk.no   
Contact: Karin Hesseberg, PhD    2245 4410    karin.hesseberg@diakonsyk.no   
Sponsors and Collaborators
Diakonhjemmet Hospital
Norwegian Health Association
Investigators
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Study Director: Anette H Ranhoff, Professor Diakonhjemmet Hospital, Vinderen, Postboks 23, 0319 Oslo, Norway

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Responsible Party: Sissel Urke Olsen, Clinical Dietitian, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT03141489     History of Changes
Other Study ID Numbers: 2017/FO148295
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Refeeding Syndrome
Disease
Pathologic Processes
Malnutrition
Nutrition Disorders