Condition category
Digestive System
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
09/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr John Saunders

ORCID ID

Contact details

Gastroenterology
MP 47
Southampton University Hospitals NHS Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom

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 measures

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

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

http://www.soton.ac.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes