Additional identifiers
EudraCT number
2007-005547-17
ClinicalTrials.gov number
Protocol/serial number
8212
Study information
Scientific title
Refeeding risks in patients requiring nutrition support: a twin centre double-blind randomised controlled trial of parenteral nutrition support
Acronym
Study hypothesis
We will conduct a randomised controlled trial to investigate the levels of nutrition support that minimise the dangers of refeeding syndrome in moderately/severely malnourished patients, while providing maximum nutrition for those in need. To do this we will conduct a twin-centre, prospective, randomised, controlled, double-blind trial of both physiological and biochemical markers of refeeding syndrome and clinical outcomes in patients needing intravenous nutrition support who, despite being at moderate or higher refeeding risk according to NICE defined criteria, are commenced at close to NICE recommended cautious levels, or more generous feeding levels (close to estimated requirements).
More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=8212
Ethics approval
Southampton and Southwest Hampshire Research Ethics Committee, 28/07/2009, ref: 09/H0504/78
Study design
Multicentre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please contact CTU@soton.ac.uk to request a patient information sheet
Condition
Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Gastrointestinal
Intervention
1. High rate parenteral nutrition: 48 hours of higher rates of feeding - 30 kcal/kg/day (including protein), 0.25 gN/kg/day
2. Low rate parenteral nutrition: 48 hours of lower rates of feeding - 15 kcal/kg/day (including protein), 0.125 gN/kg/day
Follow-up length: 1 months
Study entry: registration and one or more randomisations
Updated 09/06/2015: the trial was stopped in December 2013 due to recruitment issues.
Intervention type
Other
Phase
Phase IV
Drug names
Primary outcome measure
Refeeding Syndrome, measured within 1 week of randomisation
Secondary outcome measures
1. Clinical evidence of fluid overload, measured at day 2 of trial
2. Infective complications, measured within 1 week of randomisation
3. Intracellular electrolyte disturbance, measured on day 3
4. Length of stay, measured on day of discharge
5. Supplemental electrolyte prescription, measured within 1 week of randomisation
Overall trial start date
17/05/2010
Overall trial end date
16/05/2012
Reason abandoned (if study stopped)
Participant recruitment issue
Eligibility
Participant inclusion criteria
1. All consenting patients (minimum 18 years old, either sex) who require intravenous nutrition as assessed by the Southampton University Hospitals NHS Trust and the Royal Berkshire NHS Foundation Trust Nutrition Support Teams
2. Patients who do not require specialised parenteral nutrition regimens to meet their clinical needs
3. Patients who are at moderate or high risk of refeeding syndrome as defined by:
3.1. Moderate risk (one of the following criteria):
3.1.1. Body mass index (BMI) less than 18.5 kg/m^2
3.1.2. Unintentional weight loss greater than 10% in 3 - 6 months
3.1.3. Very little or no food intake for greater than 5 days
3.2. High risk (one of the following criteria):
3.2.1. BMI less than 16 kg/m^2
3.2.2. Unintentional weight loss greater than 15%
3.2.3. Very little nutritional intake for greater than 10 days
Or
Two of the following lesser criteria:
3.2.4. BMI less than 18.5 kg/m^2
3.2.5. Weight loss greater than 10%
3.2.6. Very little nutritional intake for greater than 5 days
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 230; UK sample size: 230
Participant exclusion criteria
1. Patients at very high risk of re-feeding syndrome (two or more of the NICE criteria: BMI less than 16 kg/m^2, recent weight loss greater than 15% body weight within 6 months, greater than 10 days with no nutritional intake) or patients with a BMI less than 14 kg/m^2)
2. Levels of K/Mg/PO4 below lower limit of normal (LLN) range from the SUHT chemical pathology laboratory prior to feeding
3. Patients with oral nutritional intake
4. Intensive care patients (who often receive variable levels of additional enteral tube feeding)
5. Patients weighing 80 kg or more giving them an estimated energy requirement above 2400 kcal/day (as we feel giving patients more than 2400 kcal/day poses too great a risk)
6. Patients with pre-existing diabetes mellitus
7. Patients unable to give informed consent to take part
Recruitment start date
17/05/2010
Recruitment end date
16/05/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southampton University Hospitals NHS Trust
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Southampton University Hospitals NHS Trust (UK)
Sponsor details
Tremona Road
Southampton
SO16 6YD
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list