Association Between Malnutrition and Clinical Outcomes in the Intensive Care Unit

NCT ID: NCT03213899

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 503 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2016-10-31

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

Conditions

Critical Illness; Malnutrition

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Flinders University

OTHER

Sponsor Role: collaborator

National University of Singapore

OTHER

Sponsor Role: collaborator

JurongHealth

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Lew CCH, Yandell R, Fraser RJL, Chua AP, Chong MFF, Miller M. Association Between Malnutrition and Clinical Outcomes in the Intensive Care Unit: A Systematic Review [Formula: see text]. JPEN J Parenter Enteral Nutr. 2017 Jul;41(5):744-758. doi: 10.1177/0148607115625638. Epub 2016 Feb 2.

Reference Type: BACKGROUND

PMID: 26838530 (View on PubMed)

Other Identifiers

2014/00878/2

Identifier Type: -

Identifier Source: org_study_id