Refeeding Syndrome Clinical Trial
Official title:
The Prevention of Refeeding Syndrome by a Diet Regime in Patient With Head and Neck Cancer
The study is based on a master thesis which showed that 72% of patients with head and neck
cancer admitted to a Danish hospital (Rigshospitalet, Copenhagen) developed refeeding
syndrome after admission.
Refeeding syndrome is characterized by a decrease in plasma phosphate levels, which develops
after the reintroduction of an adequate food intake after a longer period of starvation or
semi-starvation. This normally happens within 7 days after reintroduction of food.
The aim of this study is to minimize the incidence of refeeding syndrome in this group of
patients by reintroducing food slowly and by providing a diet low in sodium and high in
slowly absorbed carbohydrates as a prevention diet (i.e. given before a potential decrease in
plasma phosphate levels appear). Both patients that eat normally, patients with eating tubes
and patients with central vein catheters are included in the study, but the data will be
evaluated both together and separately.
A large weight loss as a result of a longer period (>30 days) of starvation or
semi-starvation will result in a metabolic adaptation to the decreased food intake. To
prevent the degradation of muscle mass into gluco- and ketogenic amino acids to be used for
energy production, a shift from gluconeogenesis to lipolysis occurs. Lipids therefore become
the primary energy fuel, and the body adapts to use ketone bodies instead of glucose. The
reduction in glucose metabolism results in a decreased need for amino acids for use in
gluconeogenesis. This means that less amino acids are needed for gluconeogenesis and
therefore important muscle mass is preserved. At the same time as the lipid stores are
degraded, an intracellular depletion of phosphate, potassium and magnesium occurs. The serum
levels of these electrolytes stay within the normal range as long as the body is in the
adaptive starvation state. A too quick reintroduction of food to the body will result in a
major glucose-induced increase in insulin secretion that will stimulate the transport of
glucose, phosphate, potassium and magnesium from plasma into the cells. Because the
extracellular blood volume is much smaller than the intracellular, an influx of these
electrolytes to the intracellular space will result in a quick and large decrease in the
plasma levels. Likewise, an influx of glucose means that it again can enter the glucolysis,
and the need for phosphate and the co-factor thiamine, for the production of ATP, will
increase. The increased production of adenosine triphosphate (ATP) will activate membrane
pumps and reestablish the membrane potential. This means that sodium will be transported from
the large intracellular space to the small extracellular, with subsequent fluid retention and
edema formation.
Therefore a slowly introduced diet low in sodium and high in slowly absorbed carbohydrates
might prevent the development of refeeding syndrome.
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Status | Clinical Trial | Phase | |
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Completed |
NCT03537170 -
Dietary Assessment and Prevalence of Refeeding Syndrome in High-risk TB Patients in Chhattisgarh, India
|
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Completed |
NCT02880072 -
Absorption of Orally Ingested Phosphate in Refeeding Syndrome
|
Phase 4 | |
Recruiting |
NCT06054139 -
Risk Factors for Refeeding Syndrome in the Surgical Intensive Care Unit
|
||
Withdrawn |
NCT02534181 -
Refeeding Syndrome in Cancer Patients
|
Phase 2 | |
Completed |
NCT05967858 -
Incidence of Refeeding Syndrome in Consecutively Admitted Patients
|
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Not yet recruiting |
NCT06344546 -
Metabolic Pathway Analysis in Intensive Care Unit Patients With Refeeding Syndrome
|
||
Completed |
NCT03141489 -
Refeeding Syndrome Among Older Adults
|
N/A | |
Completed |
NCT04966780 -
Refeeding Like Syndrome in Acute Disease
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Completed |
NCT01227850 -
Leptin, IGF1 and the Refeeding Index
|
N/A |