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Nutrition Supplementation in Hospitalized Patients

NCT02632630 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-11-06

No results posted yet for this study

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

Interventions

DRUG

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.

DIETARY_SUPPLEMENT

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.

DRUG

Crystalloid solutions

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

DIETARY_SUPPLEMENT

Oral nutritional supplementation

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

Sponsors & Collaborators

  • Academic Medical Organization of Southwestern Ontario

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Adam Rahman, MD, FRCPC · St. Joseph's Health Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02632630 on ClinicalTrials.gov