Evaluation of ‘mix-and-match parenteral nutrition’ regimens
Research type
Research Study
Full title
A mixed methods pilot study to evaluate the use of mix-and-match parenteral nutrition regimens in patients with type 3 intestinal failure
IRAS ID
299455
Contact name
Sorrel Burden
Contact email
Sponsor organisation
Salford Royal NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
Parenteral nutrition (PN) involves the intravenous administration of substrates directly into a vein, providing fluid, energy, nitrogen, micronutrients and electrolytes. Intestinal Failure (IF) is the reduction of gut function below the minimum necessary for the absorption of macronutrients, fluid and electrolytes, to such an extent that long-term PN is required to maintain health and sustain life(1). Patients administer PN two to seven nights per week via a central venous catheter (CVC), for 12-16 hours per night. Patients or their family members can be trained to administer PN or home nursing support is required twice daily to connect and disconnect infusions.
In addition to the COVID-19 pandemic, the NHS experienced a crisis in June 2019, when the Medicines and Healthcare products Regulatory Agency (MHRA) instructed a homecare company to change their PN manufacturing process due to safety concerns. This led to a substantial reduction in home PN capacity throughout the U.K. A key component of the strategy designed to mitigate the shortage of aseptic space has been to replace the use of individually tailored, compounded PN bags with more accessible, pre-prepared PN bags ‘multi-chamber’ bags, (MCB). Patients with IF have heterogeneous needs and their nutrition, electrolyte and fluid requirements are diverse due to underlying disease states, absorptive intestinal capacity, social circumstances and family support networks. Changing from using compounded bags, which are personalised to meet an individual’s nutritional and biochemical specific requirements, to MCB-PN bags is not always feasible. Therefore, in some instances a mix and match regimen is used replacing a fully compounded regimen.
This study aims to evaluate the use of mix and match regimens to determine if patient’s requirements can be met adequately without compromising clinical outcomes.
Using a mixed methods design with a cohort study and qualitative interviews we plan to recruit patients who are suitable for a mix and match regimen. This is a pilot study so only 30 participants will be recruited and followed up for 6 months on a mix and match regimen. Participant interviews will take place towards the end of the study period to enable us to document patients’ experiences.
REC name
HSC REC A
REC reference
21/NI/0112
Date of REC Opinion
28 Jun 2021
REC opinion
Further Information Favourable Opinion