NCT01227850

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2010

Completed
Last Updated

October 25, 2010

Status Verified

October 1, 2010

First QC Date

October 22, 2010

Last Update Submit

October 22, 2010

Conditions

Keywords

LeptinIGF1Refeeding IndexHypophosphataemiaPrimary focus of the study was to detemine whether the 'Refeeding Index', could reliably predict,that the refeeding syndrome would occur

Study Arms (1)

Parenteral nutrition patients.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to our department at King's College Hospital, for commencement of parenteral nutrition (PN).These included all ages above 18 and both sexes. Consent to commence PN was taken from the patients prior to starting it. Daily bloods were taken for routine laboratory analysis as part of the usual patient care.

You may qualify if:

  • Adult patients referred for parenteral nutrition at King's College Hospital between January and April 2009.

You may not qualify if:

  • Non adult patients (less than 18 years of age).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Goyale A, Ashley SL, Taylor DR, Elnenaei MO, Alaghband-Zadeh J, Sherwood RA, le Roux CW, Vincent RP. Predicting refeeding hypophosphataemia: insulin growth factor 1 (IGF-1) as a diagnostic biochemical marker for clinical practice. Ann Clin Biochem. 2015 Jan;52(Pt 1):82-7. doi: 10.1177/0004563214523739. Epub 2014 Mar 7.

MeSH Terms

Conditions

Refeeding SyndromeHypophosphatemia

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic DiseasesPhosphorus Metabolism DisordersMetabolic Diseases

Study Officials

  • Carel W Le Roux, MRCPath, MRCP, PhD

    King's College Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2010

First Posted

October 25, 2010

Last Updated

October 25, 2010

Record last verified: 2010-10