Nutritional Needs and Intake on Clinical Outcomes in Mechanically Ventilated Critically Ill Elderly Patients

Not Applicable

Completed

• Conditions: Mechanical Ventilation; Elderly; Critical Illness
• Interventions: Dietary Supplement: high protein enteral nutrition

• Registration Number: NCT02374203
• Lead Sponsor: Mackay Memorial Hospital

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 Timeline

• Study First Submitted: 2014-12-11
• Study Start: 2014-12-26
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-02-27
• Primary Completion: 2016-06-30
• Study Completion: 2016-06-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-31
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
high protein enteral nutrition	high protein enteral nutrition	supply protein over 1.5 gm/kg body weight

Primary Outcome Measures

Name	Time	Method
Determination of the energy requirements in critically ill elderly patients	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 Outcome Measures

Name	Time	Method
Higher Enteral Nutrition Intake May Reduce Hospital Mortality	first 28 days in the ICU	We included patients ≧ 65 years on mechanical ventilation ≧ 48 hours and received EN. Nutritional status was evaluated by mNUTRIC score. We calculated the energy and protein requirements as Harris-Benedict equation ╳ 1.0\~1.3 and 1.0\~2.0 gm/kg body weight respectively. Nutrition intake from EN and PN was recorded within 7 days. ICU and hospital mortalities in HNR elderly patients who could achieve more or less 80% of the prescribed nutrition were compared.

Trial Locations

Locations (1)

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan