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NCT Number: NCT02374203

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

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.

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Key information

Conditions

Critical Illness Disease Attributes Elderly Mechanical Ventilation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mackay Memorial Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high protein enteral nutrition

Dietary Supplement

supply protein over 1.5 gm/kg body weight

Primary outcomes

  1. 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

  1. Higher Enteral Nutrition Intake May Reduce Hospital Mortality

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Official study title

Clinical Dietitian, Dietetic Service, Mackay Memorial Hospital

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 27, 2015
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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