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

NCT02374203 | Completed DMC

• 1 other identifier: 14MMHIS229
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Mechanical Ventilation; Elderly

Keywords

Indirect Calorimetry; Harris-Benedict equation; critical elderly; mNUTRIC score; high nutritional risk

Outcome Measures

Primary Outcomes (1)

• 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.

  first 5 days in the ICU

Secondary Outcomes (1)

• Higher Enteral Nutrition Intake May Reduce Hospital Mortality

  first 28 days in the ICU

Study Arms (1)

high protein enteral nutrition

EXPERIMENTAL

supply protein over 1.5 gm/kg body weight

Dietary Supplement: high protein enteral nutrition

Interventions

high protein enteral nutrition DIETARY_SUPPLEMENT

supply protein over 1.5 gm/kg body weight

high protein enteral nutrition

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taiwan

Location

Related Publications (2)

• 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

  BACKGROUND

• 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.

  PMID: 29336938 RESULT

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pi-Hui Hsu

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietitian, Dietetic service

Model Details: Patients were randomized 1:1 to two tube feeding regimens: general formula and high protein formula (1.5\~2.0 gm/kg BW).

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: February 27, 2015
• Study Start: December 26, 2014
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: September 5, 2018

Record last verified: 2018-08

Locations

TW (1)