Nutrition Supplementation in Hospitalized Patients

NCT02632630 | Completed Phase 2

• 1 other identifier: INN15-007
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Keywords

Peripheral Parenteral Nutrition; Oral nutritional supplementation; Acute Care hospitals

Outcome Measures

Primary Outcomes (1)

• Successful participant recruitment

  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.

  12 months

Secondary Outcomes (2)

• Adherence to treatment

  30 days

• Number of participants to experience clinical re-feeding syndrome.

  30 days

Study Arms (4)

Amino Acids w/Electrolytes in Dextrose

ACTIVE COMPARATOR

Peripheral parenteral nutrition (PPN)

Drug: Amino Acids w/Electrolytes in Dextrose

Ensure product

ACTIVE COMPARATOR

Calorie and protein dense oral nutritional supplement for patients with elevated nutritional needs.

Dietary Supplement: Ensure product

Crystalloid solutions

ACTIVE COMPARATOR

Standard care intravenous maintenance fluids.

Drug: Crystalloid solutions

Oral nutritional supplementation

ACTIVE COMPARATOR

Nutrient-enhanced drink products that provide macronutrients and micronutrients with the aim of increasing oral nutritional intake.

Dietary Supplement: Oral nutritional supplementation

Interventions

Amino Acids w/Electrolytes in Dextrose DRUG

Patients will receive peripheral parenteral nutrition to a maximum of 2L/day (with a minimum rate of 45mL/hour and a maximum rate of 85mL/hour) of pre-packaged Peri-OLIMEL 2.5% E. 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., for up to 5 days of hospitalization or until discharge, whichever is sooner.

Also known as: Peri-OLIMEL 2.5% E (Baxter)

Amino Acids w/Electrolytes in Dextrose

Ensure product DIETARY_SUPPLEMENT

Patients will receive one package of Ensure two times daily in hospital. At discharge, patients randomized to receive Ensure will be provided with 28 packages of Ensure with instructions to attempt to consume 1 package per day.

Ensure product

Crystalloid solutions DRUG

Standard care intravenous maintenance fluid administration for up to 5 days of hospitalization or until discharge, whichever is sooner.

Also known as: normal saline, dextrose, lactated Ringer's

Crystalloid solutions

Oral nutritional supplementation DIETARY_SUPPLEMENT

Standard of care oral nutritional supplementation is determined by the clinician. A dietitian may also be involved.

Oral nutritional supplementation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Academic Medical Organization of Southwestern Ontario: collaborator

Study Sites (1)

LHSC-University Hospital

London, Ontario, N6A 5A5, Canada

Location

Related Publications (1)

• Mrkobrada M, Patel A, Chakroborty A, Handsor S, Armstrong D, Rahman A. NutriSup-PPN: A pilot randomized control trial of oral nutritional supplementation (ONS) and peripheral parenteral nutrition (PPN) in canadian, malnourished, hospitalized patients. Clin Nutr ESPEN. 2023 Feb;53:107-112. doi: 10.1016/j.clnesp.2022.04.008. Epub 2022 Apr 23.

  PMID: 36657900 DERIVED

MeSH Terms

Conditions

Malnutrition

Interventions

Glucose; Crystalloid Solutions; Saline Solution; Ringer's Lactate; Dietary Supplements

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Adam Rahman, MD, FRCPC

  St. Joseph's Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 17, 2015
• Study Start: March 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

CA (1)