Clinical trial NCT02632630: Nutrition Supplementation in Hospitalized Patients
Official title: Nutrition Supplementation in Hospitalized Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malnutrition
Keywords: Peripheral Parenteral Nutrition
Oral nutritional supplementation
Acute Care hospitals
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Academic Medical Organization of Southwestern Ontario
First posted: 2015-12-17
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Patients with severe malnutrition risk are 7.4 times more likely to die in hospital than well-nourished patients, and carry a 30-day readmission rate of \>46%. Although malnutrition is common and is associated with extremely poor outcomes, it is neglected and undertreated. This is a randomized controlled pilot trial to rapidly identify at-risk hospitalized medical patients, and then provide nutritional supplementation in hospital and after discharge for 28 days. In select at-risk patients, 5 days of nutrition delivered through a peripheral vein will be used in addition to oral nutritional supplementation.

Detailed description: In this pilot trial, the feasibility of the trial protocol will be established in two centres in Canada. Patients at high risk of malnutrition will be identified within 48 hours of hospital admission using Subjective Global Assessment criteria. Patients will be randomized in a factorial design fashion via a centralized, internet-based randomization protocol to one of the following arms:

1. Peripheral parenteral nutrition and enhanced oral supplementation;
2. Peripheral parenteral nutrition and standard care for oral supplementation;
3. Standard care for parenteral fluid administration and enhanced oral supplementation;
4. Standard care for parenteral fluid administration and standard of care for oral supplementation.

Peripheral parenteral nutrition (PPN) is intravenous nutrition consisting of dextrose, amino acids, fat, and electrolytes through a peripheral vein. Peri-OLIMEL 2.5% E, parenteral solution (Baxter) will be administered in this study. Patients will be randomized to PPN vs. standard care intravenous maintenance fluid administration for up to 5 days of hospitalization or until discharge, whichever is sooner. The PPN will be administered in place of their maintenance crystalloid solution, and will be adjusted or stopped as clinically indicated by the attending medical team.

If there is no maintenance crystalloid fluid administration, the parenteral nutrition solution will be administered at a rate of 0.85mL/kg/hour.

The minimum infusion rate will be 45 mL per hour (for participants who weigh 53 kg or less). The minimum infusion rate would provide a supplementation of 1,080 kcal/day.

The maximum infusion rate will be 85 mL/hour (for participants who weigh 100 kg or more). The maximum infusion rate would provide a supplementation of 2,040 kcal/day.

The PPN solution has a low osmolarity (\< 900 mOsm) to reduce risk of phlebitis (Peri-OLIMEL 2.5% E is760mOsm). The use of PPN, compared to total parenteral nutrition (TPN) offers safety advantages. PPN avoids cost and complication of central line placement, avoids line sepsis and reduces the likelihood re-feeding syndrome \[30-32\]. Peri-OLIMEL 2.5% E contains lipids and electrolytes further reducing the likelihood of vein irritation and refeeding syndrome. All patients will be monitored closely and patients with uncontrolled blood sugars will be excluded.

Patients randomized to Oral Nutritional Supplementation (ONS) will receive standard menu or standard menu plus oral nutritional supplements. The investigators will provide patients with one package of ONS (Resource 2.0 - 237 mL, 474 calories; or similar product) two times daily in hospital. Although the patient will be encouraged, they will not be required to consume all of the oral supplementation product. Upon discharge, patients will be provided with ONS product to take home.

All participants will be monitored daily in hospital. After discharge, the investigators will follow up with the participant at a 30-day follow-up clinic visit, to collect data regarding clinical outcomes, quality of life, physical function, and nutrition-related variables.

This pilot study will establish the feasibility of a paradigm-changing protocol that will rapidly identify and aggressively treat malnutrition in hospitalized patients, with the goal of improving function, quality of life, healthcare utilization, and reducing the risk of adverse clinical events.

Eligibility criteria: Inclusion Criteria:

* Subjective Global Assessment (SGA) category B or C.
* Have been hospitalized for less than 48 hours.

Exclusion Criteria:

* Have an allergy or intolerance to any component of the oral supplement or parenteral nutrition.
* Have a contraindication to administration of IV fluid (i.e. are in volume overloaded state, are being given IV furosemide).
* Are currently suffering from refeeding syndrome.
* Have a pre-existing medical condition that prevents oral intake of full fluids.
* Have a diagnosis or suspicion of septic shock.
* Have an expected length of stay of less than 48 hours from the time of assessment.
* Have a current diagnosis of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome.

Primary outcomes:
measure: Successful participant recruitment
timeFrame: 12 months
Secondary outcomes:
measure: Adherence to treatment
timeFrame: 30 days
measure: Number of participants to experience clinical re-feeding syndrome.
timeFrame: 30 days
Other outcomes:
Locations:
city: London
country: Canada
facility: LHSC-University Hospital
state: Ontario
Study officials:
affiliation: St. Joseph's Health Care
name: Adam Rahman, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: