Clinical Trial: Refeeding Syndrome Among Older Adults

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Safe Refeeding of Severely Malnourished Patients 65 Years or Older

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.This study will be divided into two parts. Part I: a cross-sectional cohort study, monitoring occurrence of hypophosphatemia on patients detected as not at risk for RFS according to NICE guidelines. Part II: a double blinded RCT study, with the aim of tube feeding patients at risk for developing RFS, and assigned them 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.

Detailed Summary:

Before 2006, the recommended initial refeeding rate was around 20-25kcal/kg/day for severely malnourished patients. But due to the risk of RFS, the National Institute of Health and Clinical Excellence (NICE) in 2006 published new guidelines, recommending a very cautious refeeding level of only 5-10 kcal/kg/day. However, the supporting literature underpinning the evidence that results in the above recommendations is weak, and is mostly based upon cohort studies, case series and consensus expert opinions. RFS was first identified and reported on in the late forties when starved concentration camp inmates and prisoners of war developed cardiac arrest, neuralgic symptoms and/or peripheral edema during recommencement of feeding. Similar symptoms were noticed again during the 1970's and 1980's, when parenteral nutrition was used widely, and carbohydrate provision was not restricted.

Patients defined as at risk for RFS are those who are malnourished and have recently lost weight. In addition, patients with, eating disorders, uncontrolled diabetes, cancer, malabsorption syndromes, alcoholics, surgical patients, elderly, and patients who are fasting or have undergone bariatric surgery, are high risk groups. It is well known that low levels of electrolytes are fatal, and may cause cardiac-and lung problems, affect the gastrointestinal-and the immune system, and increase the occurrence of sepsis and infections. Even severely malnourished patients have normal electrolyte levels upon admission, but when refeeding, a rapid drop in electrolytes, especially phosphate, may occur, usually within 2-5 days. Electrolytes like potassium and sodium are measured routinely, but magnesium and phosphate are not included in routine laboratory tests, and therefore often overlooked. Studies have found that patients screened as "not at risk" also develop RFS confirming the need for monitoring
Sponsor: Diakonhjemmet Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • EQ-5D-5L [ Time Frame: Day 4 and after 3 months ]
    Health related quality of life. Questionnaires
  • 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.
  • Mortality [ Time Frame: register mortality after 3 months ]
    Mortalityrates during and after 3 months
  • Readmission rates [ Time Frame: Readmissionrates after 3 months. ]
    Readmission of patients in the study
  • Weight [ Time Frame: During hospital stay and at 3 months ]
    Measuring bodyweight during hospital
  • 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.
  • 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.
  • 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


Original Secondary Outcome: Same as current

Information By: Diakonhjemmet Hospital

Dates:
Date Received: February 17, 2017
Date Started: April 10, 2017
Date Completion: December 2019
Last Updated: May 4, 2017
Last Verified: May 2017