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
Northern Care Alliance
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
Summary of Research
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.
Summary of Results
Background: People with chronic intestinal failure (IF) are unable to absorb sufficient nutrition and fluid through their gut to meet their needs and so require home parenteral nutrition (HPN). HPN is compounded by specialist pharmacy services under strict conditions. It is given in the patients’ home, using an infusion pump, directly into the bloodstream via an intravenous line. This is done over twelve or more hours every night, or several nights per week. HPN solution can be in the form of either single chamber bags compounded individually matched to each person; or as multi-chamber bags (MCBs) mass-produced to wide range of standardised compositions. For some people the HPN regimen consists of MCBs alone. For others the regimen consists of individually compounded bags on some nights and MCBs on others, and this is known as a hybrid regimen.Aims: To conduct an initial pilot study to evaluate quality of life (QoL) and clinical outcomes with MCB only and hybrid HPN regimens in people with non-malignant chronic intestinal failure.
Methods: This small study used mixed methods and collected data from participants between July 2021 and January 2023. Data were collected on HPN prescriptions and clinical outcomes at baseline and after 180 days post discharge. Patients were interviewed to determine their lived experiences and completed a QoL questionnaire. Quantitative data were analysed using descriptive statistics with rate ratios (RR) and qualitative data were analysed using framework analysis.
Key findings: We recruited 28 participants, (16 on hybrid, 12 on MCB only). There were no catheter-related bloodstream infections during the 180 days following discharge home. Those on hybrid had more hospital readmissions (RR 1.5, 95% CI 0.2, 16.6, i.e. there was 1.5 the rate of readmission in the hybrid group compared with the MCB alone group) and more central venous catheter complications not requiring readmission (RR 3.8, 95% CI 0.4, 177, ie there were 3.8 times more central venous catheter complications compared with MCB only.) Those on hybrid however had fewer symptoms of malaise (RR 0.4, 95% CI 0.08, 1.4) and supply issues (RR 0.2, 95% CI 0.004, 1.9) Patients on hybrid regimens perceived no issues arising specifically from having two rather than one PN bag type. Compounded bags require constant refrigeration whereas MCBs do not. Those on MCB alone appreciated travel flexibility this provides and that unlike hybrid regimens an extra fridge in the house is not needed. Those on MCBs consistently reported that the inter-chamber seals were difficult to open.
Conclusions: The results revealed interesting trends in clinical outcomes and shed light on key issues of life on these regimen types as viewed from the patient perspective. These could potentially form the basis for planning and design of a larger study, the results of which could further inform and support decision making by clinicians and people on HPN.
Dissemination, outputs, and impact: This summary will be provided to the national support group PINNT (Patients on Intravenous and Nasogastric Nutrition Treatment.) The full paper will be submitted to a nutrition journal for consideration for publicationREC name
HSC REC A
REC reference
21/NI/0112
Date of REC Opinion
28 Jun 2021
REC opinion
Further Information Favourable Opinion