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Clinical Trials/NCT02374203
NCT02374203CompletedNot Applicable

Clinical Dietitian, Dietetic Service, Mackay Memorial Hospital

Mackay Memorial Hospital1 site in 1 country190 target enrollmentStarted: December 26, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
190
Locations
1
Primary Endpoint
Determination of the energy requirements in critically ill elderly patients

Study Overview

Brief Summary

The purposes of this study were to investigate the caloric requirement and clinical outcomes in mechanically ventilated critically ill elderly patients and identify those at high nutritional risk who require high protein formula intervention.

Detailed Description

The elderly population is rapidly increasing, but studies on calorie requirement in critically ill elderly patients are few, and indirect calorimetry (IC) is not available in every intensive care unit (ICU). The aim of this study was to compare IC and Harris-Benedict (HB) predictive equation in different BMI (body mass index) groups. And to investigate whether the nutrition intake from EN (enteral nutrition) and PN (parenteral nutrition) created a better clinical outcome than EN alone in HNR (high nutritional risk) mechanically ventilated critically ill elderly patients.Inclusion criteria were: age ≧65 years old, APACHE Π score ≧15, mechanical ventilation ≧48 hours and on NG tube feeding. Nutritional risk was screened by mNUTRIC and GNRI. Indirect calorimetry and HB equation were used to assess energy requirements. Patients were randomized 1:1 to two tube feeding regimens: general formula and high protein formula (1.5~2.0 gm/kg BW). Nutritional intake from EN, the type and amount of intravenous nutrition within 7 days, tolerance to feeding, MVD (Mechanical Ventilation Day), newly diagnosed VAP (Ventilator Associated Pneumonia), ICU and hospital LOS (Length of Stay) and date of death were recorded. We used SAS version 9.4 for statistical analysis. Statistically significance was set at α=0.05.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •APACHE Π score ≧ 15
  • •≧ 65 years
  • •on mechanical ventilation ≧48 hours
  • •received EN

Exclusion Criteria

  • •Use of total parenteral nutrition
  • •Fasting >5 days
  • •Brain death
  • •Terminal cancer

Arms & Interventions

high protein enteral nutrition

Experimental

supply protein over 1.5 gm/kg body weight

Intervention: high protein enteral nutrition (Dietary Supplement)

Outcomes

Primary Outcomes

Determination of the energy requirements in critically ill elderly patients

Time Frame: first 5 days in the ICU

A total of 177 critically ill elderly patients (≧ 65 years old) underwent IC for measured resting energy expenditure (MREE). Estimated calorie requirement was calculated by the HB equation, using actual body weight (ABW) and ideal body weight (IBW) separately. Patients were divided into four BMI groups. One-way ANOVA and Pearson's correlation coefficient were used for statistical analyses.

Secondary Outcomes

  • Higher Enteral Nutrition Intake May Reduce Hospital Mortality(first 28 days in the ICU)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pi-Hui Hsu

Dietitian, Dietetic service

Mackay Memorial Hospital

Study Sites (1)

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