Refeeding risks in patients requiring nutrition support

• Research type

  Research Study

• Full title

  Refeeding risks in patients requiring nutrition support. A twin centre double-blind randomised controlled trial of parenteral nutrition support.

• IRAS ID

  13798

• Sponsor organisation

  University Hospital Southampton NHS Foundation Trust

• Eudract number

  2007-005547-17

• ISRCTN Number

  n/a

• Research summary

  Malnourished patients who need nutrition support need to receive a carefully considered level of feeding because they are put at risk from either over-feeding or under-feeding. Too much risks life-threatening refeeding syndrome (disturbances of metabolism as food arrives in a system changed by starvation), while too little leaves patients vulnerable to the many problems of malnutrition itself. The 2006 National Institute for Clinical Excellence (NICE) guidelines recommended very low levels of initial feeding in undernourished groups but these were based on little evidence and many UK experts do not follow them as they think they are unnecessarily cautious, may delay resolution of malnutrition, prolong the need for nutrition support and create additional costs.We therefore aim to clarify whether following the NICE guidelines is important by conducting a trial looking for a number of clinical problems and markers of refeeding syndrome when commencing patients needing nutrition support at levels meeting approximately 50% of their estimated needs (as NICE recommends) or 100% of their estimated needs (as used in numerous centres based on expert opinion). All patients in the trial will be monitored closely to ensure their safety. This work will be carried out at two different sites, Southampton University Hospitals NHS Trust and The Royal Bournemouth Hospital Foundation Trust, over a period of 30 months.Whilst the general incidence of refeeding complications in the UK is unknown, the fact that there is variable practice and significant problems are likely from either too much or too little feeding means that the results of this study will directly benefit patient safety. Additionally financial savings should be realised from reduced complications, bed days, staff time and pathology tests amounting to hundreds of pounds per patient with total potential NHS savings of millions of pounds through confirmation of best practice.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  09/H0504/78

• Date of REC Opinion

  28 Jul 2009

• REC opinion

  Further Information Favourable Opinion