Refeeding risks in patients requiring nutrition support
| ISRCTN | ISRCTN74013349 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74013349 |
| EudraCT/CTIS number | 2007-005547-17 |
| Secondary identifying numbers | 8212 |
- Submission date
- 12/05/2010
- Registration date
- 12/05/2010
- Last edited
- 09/06/2015
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr John Saunders
Scientific
Scientific
Gastroenterology, MP 47
Southampton University Hospitals NHS Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom
Study information
| Study design | Multicentre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact CTU@soton.ac.uk to request a patient information sheet |
| Scientific title | Refeeding risks in patients requiring nutrition support: a twin centre double-blind randomised controlled trial of parenteral nutrition support |
| Study objectives | 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(s) | Southampton and Southwest Hampshire Research Ethics Committee, 28/07/2009, ref: 09/H0504/78 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 17/05/2010 |
| Completion date | 16/05/2012 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 230; UK sample size: 230 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/05/2010 |
| Date of final enrolment | 16/05/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southampton University Hospitals NHS Trust
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
| Website | http://www.soton.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
