Clinical Trial: Incidence and Risk Factors of Refeeding Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Incidence and Risk Factors of Refeeding Syndrome in Head and Neck Cancer Patients - An Observational Study

Brief Summary: 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.

Detailed Summary:

Consecutive patients referred to the Department of Otorhinolaryngology and Audiology on suspicion of cancer during the study period from February to August 2011. Patients were asked for participation if they met the following inclusion criteria: age ≥ 18 years, suspicion or diagnosis with HNC, and first time referral. Patients were excluded if not able to understand and speak Danish, having severe dementia and/or renal impairment (women: p-creatinine > 180 μmol/l, men: p-creatinine > 200 μmol/l).

Every participant was observed for eight days after admission or referral to the clinic. Blood samples and interviews were performed at baseline and at day 2, 4 and 7.

Potential factors defining high risk were analyzed by comparing those patients developing RFS or RFF with those that did not. Baseline information consisted of data from the interview and supplemental information in medical records. As a part of the interview, the participant was asked about dietary history in order to assess daily habitual energy end protein intake. Hand grip strength (HGS) was measured, and the participant performed a maximal step test on a 20 cm high bench. The nutritional status was evaluated using the NRS-2002 screening tool (13) and refeeding risk according to the NICE-guidelines (14). Intake of energy, protein, and fluids was registered and compared to the estimated requirements. Standardized questionnaires were used for the interviews, and blood samples were analyzed as part of daily routine in in-patients, while outpatients had their blood samples collected by their general practitioner or by accredited hospital laboratories close to their homes. For participants with a body mass index (BMI) < 30 kg/m2, energy requirement was calculated using Harris & Benedict's equations for men and women respectively (15). A p
Sponsor: University of Copenhagen

Current Primary Outcome: Decrease in plasma phosphate after start of feeding [ Time Frame: 1 week ]

Plasma phosphate measured every day the initial day of feeding after admission


Original Primary Outcome: Same as current

Current Secondary Outcome: Occurence of relevant clinical symptoms along with a decrease in plasma phosphate [ Time Frame: 1 week ]

Daily registration of symptoms: oedema, confusion, dyspnoea, hypotension, arrhythmia, seizures


Original Secondary Outcome: Same as current

Information By: University of Copenhagen

Dates:
Date Received: February 24, 2014
Date Started: February 2011
Date Completion:
Last Updated: February 26, 2014
Last Verified: February 2014