Clinical Trials Directory

Trials / Completed

CompletedNCT03213899

Association Between Malnutrition and Clinical Outcomes in the Intensive Care Unit

Association Between Malnutrition and Hospital Mortality and Duration of Intensive Care Unit Admission in the Critically Ill: a Prospective Singapore Cohort Study

Status
Completed
Phase
Study type
Observational
Enrollment
503 (actual)
Sponsor
JurongHealth · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Timeline

Start date
2015-08-01
Primary completion
2016-10-31
Completion
2016-10-31
First posted
2017-07-11
Last updated
2017-07-11

Source: ClinicalTrials.gov record NCT03213899. Inclusion in this directory is not an endorsement.