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

Primary Purpose

Critical Illness, Mechanical Ventilation, Elderly

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
high protein enteral nutrition
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring Indirect Calorimetry, Harris-Benedict equation, critical elderly, mNUTRIC score, high nutritional risk

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mackay Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

high protein enteral nutrition

Arm Description

supply protein over 1.5 gm/kg body weight

Outcomes

Primary Outcome Measures

Determination of the energy requirements in critically ill elderly patients
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

Higher Enteral Nutrition Intake May Reduce Hospital Mortality
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.

Full Information

First Posted
December 11, 2014
Last Updated
August 31, 2018
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02374203
Brief Title
Nutritional Needs and Intake on Clinical Outcomes in Mechanically Ventilated Critically Ill Elderly Patients
Official Title
Clinical Dietitian, Dietetic Service, Mackay Memorial Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 26, 2014 (Actual)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
June 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Mechanical Ventilation, Elderly
Keywords
Indirect Calorimetry, Harris-Benedict equation, critical elderly, mNUTRIC score, high nutritional risk

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients were randomized 1:1 to two tube feeding regimens: general formula and high protein formula (1.5~2.0 gm/kg BW).
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high protein enteral nutrition
Arm Type
Experimental
Arm Description
supply protein over 1.5 gm/kg body weight
Intervention Type
Dietary Supplement
Intervention Name(s)
high protein enteral nutrition
Intervention Description
supply protein over 1.5 gm/kg body weight
Primary Outcome Measure Information:
Title
Determination of the energy requirements in critically ill elderly patients
Description
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.
Time Frame
first 5 days in the ICU
Secondary Outcome Measure Information:
Title
Higher Enteral Nutrition Intake May Reduce Hospital Mortality
Description
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.
Time Frame
first 28 days in the ICU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pi-Hui Hsu
Organizational Affiliation
Mackay Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
Citation
Hsu PH, Lee CH, Kuo LK, Kung YC, Chen WJ, Tzeng MS. Higher Energy and Protein Intake from Enteral Nutrition May Reduce Hospital Mortality in Mechanically Ventilated Critically Ill Elderly Patients. International Journal of Gerontology. Available online 26 March 2018. https://doi.org/10.1016/j.ijge.2018.03.001
Results Reference
background
PubMed Identifier
29336938
Citation
Hsu PH, Lee CH, Kuo LK, Kung YC, Chen WJ, Tzeng MS. Determination of the energy requirements in mechanically ventilated critically ill elderly patients in different BMI groups using the Harris-Benedict equation. J Formos Med Assoc. 2018 Apr;117(4):301-307. doi: 10.1016/j.jfma.2017.12.010. Epub 2018 Jan 12.
Results Reference
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Nutritional Needs and Intake on Clinical Outcomes in Mechanically Ventilated Critically Ill Elderly Patients

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