Association Between Malnutrition and Clinical Outcomes in the Intensive Care Unit

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213899
• Other study ID #: 2014/00878/2
• Status: Completed
• Phase: N/A
• First received: July 7, 2017
• Last updated: July 9, 2017
• Start date: August 1, 2015
• Est. completion date: October 31, 2016

Study information

• Verified date: July 2017
• Source: JurongHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: October 31, 2016
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Critical Illness
• Malnutrition

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
JurongHealth	Flinders University, National University, Singapore

References & Publications (1)

Lew CCH, Yandell R, Fraser RJL, Chua AP, Chong MFF, Miller M. Association Between Malnutrition and Clinical Outcomes in the Intensive Care Unit. JPEN J Parenter Enteral Nutr. 2016 Feb 1:148607115625638. doi: 10.1177/0148607115625638. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital mortality	Death during hospitalization	Up to one year after admission to the ICU
Primary	ICU length of stay	Duration of the first intensive care unit admission	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