Clinical trial NCT02374203: 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
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Mechanical Ventilation
Elderly
Keywords: Indirect Calorimetry
Harris-Benedict equation
critical elderly
mNUTRIC score
high nutritional risk
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 190
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Determination of the energy requirements in critically ill elderly patients
timeFrame: first 5 days in the ICU
Secondary outcomes:
measure: Higher Enteral Nutrition Intake May Reduce Hospital Mortality
timeFrame: first 28 days in the ICU
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: Pi-Hui Hsu
role: PRINCIPAL_INVESTIGATOR
References:
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
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.