Nutrition Supplementation in Hospitalized Patients

NCT ID: NCT02632630

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-02-28

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.

Conditions

Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Amino Acids w/Electrolytes in Dextrose

Peripheral parenteral nutrition (PPN)

Group Type: ACTIVE_COMPARATOR

Amino Acids w/Electrolytes in Dextrose

Intervention Type: 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.

Ensure product

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

Group Type: ACTIVE_COMPARATOR

Ensure product

Intervention Type: 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.

Crystalloid solutions

Standard care intravenous maintenance fluids.

Group Type: ACTIVE_COMPARATOR

Crystalloid solutions

Intervention Type: DRUG

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

Oral nutritional supplementation

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

Group Type: ACTIVE_COMPARATOR

Oral nutritional supplementation

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Amino Acids w/Electrolytes in Dextrose

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.

Intervention Type: DRUG

Ensure product

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.

Intervention Type: DIETARY_SUPPLEMENT

Crystalloid solutions

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

Intervention Type: DRUG

Oral nutritional supplementation

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Peri-OLIMEL 2.5% E (Baxter); normal saline, dextrose, lactated Ringer's

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academic Medical Organization of Southwestern Ontario

OTHER

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Rahman, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Health Care

Locations

LHSC-University Hospital

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36657900 (View on PubMed)

Other Identifiers

INN15-007

Identifier Type: -

Identifier Source: org_study_id