Nutrition Supplementation in Hospitalized Patients

Phase 2

Completed

• Conditions: Malnutrition
• Interventions: Drug: Amino Acids w/Electrolytes in Dextrose; Drug: Crystalloid solutions; Dietary Supplement: Ensure product; Dietary Supplement: Oral nutritional supplementation

• Registration Number: NCT02632630
• Lead Sponsor: Lawson Health Research Institute

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-14
• Study First Posted: 2015-12-17
• Study Start: 2016-03
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-02
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Amino Acids w/Electrolytes in Dextrose	Amino Acids w/Electrolytes in Dextrose	Peripheral parenteral nutrition (PPN)
Crystalloid solutions	Crystalloid solutions	Standard care intravenous maintenance fluids.
Ensure product	Ensure product	Calorie and protein dense oral nutritional supplement for patients with elevated nutritional needs.
Oral nutritional supplementation	Oral nutritional supplementation	Nutrient-enhanced drink products that provide macronutrients and micronutrients with the aim of increasing oral nutritional intake.

Primary Outcome Measures

Name	Time	Method
Successful participant recruitment	12 months	This pilot study will demonstrate feasibility of recruitment if investigators are able to recruit 100 participants over 12 months. A total recruitment of 15 patients/month is considered as reasonable given the high numbers of competing studies, missed patients, and consent failure rates.

Secondary Outcome Measures

Name	Time	Method
Adherence to treatment	30 days	Adherence to the study treatments will be defined as ≥90% of prescribed intervention being administered across all patients. Preliminary estimates of non-administration of the trial intervention are needed, along with strategies that maximize exposure to the intervention.
Number of participants to experience clinical re-feeding syndrome.	30 days	It is expected that some participants will experience metabolic electrolyte abnormalities related to initiation of feeding requiring electrolyte and fluid replacement but it is expected that clinical re-feeding syndrome characterized by cardiac, pulmonary, neurological abnormalities will be absent; an opinion informed by the investigators' recent systematic review.

Trial Locations

Locations (1)

LHSC-University Hospital; 🇨🇦 London, Ontario, Canada