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Refeeding Syndrome clinical trials

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NCT ID: NCT03141489 Recruiting - Refeeding Syndrome Clinical Trials

Refeeding Syndrome Among Older Adults

Start date: April 10, 2017
Phase: N/A
Study type: Interventional

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 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.

NCT ID: NCT02880072 Completed - Clinical trials for Cancer of the Head and Neck

Absorption of Orally Ingested Phosphate in Refeeding Syndrome

Start date: March 2014
Phase: Phase 4
Study type: Interventional

A phosphate supplement is part of the treatment of patients with the refeeding syndrome (RFS). It is not known, if the generalized edema also affects the intestine to decrease absorption. The aim was to investigate, if oral treatment is possible in mild to moderate RFS. In a randomized crossover design 12 hospitalized head-neck cancer patients ingested four oral solutions of phosphate in two-day periods. In a low-dose period the investigators compared five mmol phosphate from either skimmed milk or Di-sodiumphosphate-di-hydrate and potassium di-hydrogens-phosphate with black currant flavor (PBC), and in a high-dose period 20 mmol from either Addiphos® or the PBC-solution. P-phosphate was measured two and four hours after the ingestion, the urinary excretion after four hours. P-phosphate significantly increased after PBC in both the low- and high-dose and Addiphos®, but not after skimmed milk. The increase was larger after Addiphos® than the PBC-solution. There was no difference in the increase between the patients with low p-phosphate and those with normal values, and no correlation between baseline p-phosphate and percent increase. There was no group difference in the urinary excretion of phosphate. The investigators conclude that phosphate can be readily absorbed after oral administration, but skimmed milk can´t be recommend for this purpose.

NCT ID: NCT02621229 Recruiting - Anorexia Nervosa Clinical Trials

Refeeding Syndrome in Anorexia Nervosa

Start date: December 2015
Phase: N/A
Study type: Interventional

The purpose of this multi-center randomized controlled trial is to compare lower calorie refeeding to higher calorie refeeding for hospitalized adolescents and young adults with AN. The investigators will compare efficacy (achievement and maintenance of clinical remission at 12 months), safety during hospitalization, and cost effectiveness (including costs of initial and re hospitalization, 12 month follow up and safety/adverse events).

NCT ID: NCT02534181 Withdrawn - Cancer Clinical Trials

Refeeding Syndrome in Cancer Patients

Start date: July 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate whether a nutritional strategy is effective in critically ill patients with cancer diagnosed with refeeding syndrome.

NCT ID: NCT02073032 Completed - Clinical trials for Cancer of the Head and Neck

Incidence and Risk Factors of Refeeding Syndrome

Start date: February 2011
Phase: N/A
Study type: Observational

The main objective of this observational survey was to determine the incidence rate of refeeding phenomena (RFF) (defined as any decline in p-phosphate) and RFS (defined as any decline in p-phosphate with additional development of any of the following clinical symptoms: oedema, confusion, dyspnoea, hypotension, arrhythmia, seizures) among recently admitted or referred HNC patients to the Department of Otorhinolaryngology for surgery. The second objective was to determine if informations at admittance could identify HNC patients at high risk of developing RFF and RFS.

NCT ID: NCT01845922 Recruiting - Refeeding Syndrome Clinical Trials

The Effect of a Diet Based on Low Sodium and Slowly Absorbed Carbohydrates on the Incidence of Refeeding Syndrome in Patients With Head and Neck Cancer

Start date: May 2013
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT01227850 Completed - Refeeding Syndrome Clinical Trials

Leptin, IGF1 and the Refeeding Index

Start date: n/a
Phase: N/A
Study type: Observational

Background and study hypothesis: Refeeding syndrome is a dangerous condition which could arise if patients who have had little or no food for many days, are started on any form of feeding. The metabolic consequences of this condition could affect the heart, lungs and nervous system of the patient and cause serious imbalance in the level of salts in the body. The available guidelines for predicting that refeeding syndrome may occur are very subjective since they depend mainly on a history which is sometimes difficult to obtain from the patient. The main biochemical landmark that refeeding syndrome has occurred is a fall in the phosphate levels once feeding has been started. There are currently no biochemical markers that can identify patients at risk of developing refeeding syndrome. Leptin and IGF1 are hormones which have been observed to go down if someone has had little or no food for a while. The investigators therefore hypothesized that using a combination of leptin and IGF1 values in a 'Refeeding Index' would make the latter a useful biochemical marker to predict that refeeding may occur, hence take the precautionary measures to avoid its occurrence before starting feeding. Design: Thirty five consecutive patients referred for commencement of parenteral nutrition (PN) were included. Serum leptin and IGF1 were measured prior to starting PN. Electrolytes, liver and renal function tests were measured before and daily for one week after initiating PN. The primary outcome was a decrease in phosphate on day two or three after initiating PN. A 'Refeeding Index' (RI) was defined as leptin x IGF1 divided by 2800 to produce a ratio of 1.0 in patients who are well nourished.