Association Between Malnutrition and Clinical Outcomes in the Intensive Care Unit

Completed

• Conditions: Critical Illness; Malnutrition

• Registration Number: NCT03213899
• Lead Sponsor: JurongHealth

Brief Summary

Previous studies have demonstrated the direct associations between malnutrition and hospital mortality as well as the length of stay in critically ill patients. However, the validity of these results may be limited by inappropriate diagnoses of malnutrition, small sample size, possible treatment bias, and sub-optimal statistical adjustment. This study aimed to further examine the aforementioned associations by addressing these limitations.

Detailed Description

Design:

* Prospective cohort study

Setting:

* 35-bedded integrated intensive care/ high dependency unit in Ng Teng Fong General Hospital. Patients' status can be changed between ICU-status and HD-status within the same ICU-/ HD-bed

Participants:

* All adult patients who will be admitted to the unit between August-2015 to October-2016 for ≥ 24 hours

Intervention:

Nil. Given the observational nature of this study, no attempt will be made to standardize care, including nutritional practices.

Measurement:

* As per routine care, a validated nutritional assessment tool \[7-point Subjective Global Assessment (7-point SGA)\] will be used to determine patients' nutritional status within 48 hours of ICU admission

* The primary outcomes will be hospital mortality and ICU length of stay. To measure hospital mortality, all patients will be followed until hospital discharge or death for up to one year after ICU admission. For ICU length of stay (in days), duration will be measured from the date of the first ICU admission to the date of the first change in ICU-status to HD-status or discharge to the general ward

Analysis:

* Modified Cox regression model with robust variance and logistic regression will be used to determine the associations between nutritional status and hospital mortality. Analyses will be conducted in two ways: 1) presence versus absence of malnutrition, and 2) dose-dependent association for each 1-point decrease in the 7-point SGA

* Multiple linear regression will be applied to determine the associations between nutritional status and ICU length of stay

Study Timeline

• Study Start: 2015-08-01
• Primary Completion: 2016-10-31
• Study Completion: 2016-10-31
• Status Verified: 2017-07
• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-09
• Last Update Submitted: 2017-07-09
• Study First Posted: 2017-07-11
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 503

Inclusion Criteria

• ≥ 18 years old who had ≥ 24 hours length of stay in the ICU
• received a nutrition assessment (7-point SGA) from a dietitian within 48 hours of admission to the ICU

Exclusion Criteria

• Nil

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital mortality	Up to one year after admission to the ICU	Death during hospitalization
ICU length of stay	From the date of the first ICU admission to the date of the first change in ICU-status to HD-status or discharge to the general ward, for up to one year after admission to the ICU	Duration of the first intensive care unit admission