Critical IllnessNCT03213899
Association Between Malnutrition and Clinical Outcomes in the Intensive Care Unit
An observational study of Critical Illness and Malnutrition, run by JurongHealth.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Malnutrition
- How many people
- 503 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2015to 31 Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients ≥ 18 years old who had ≥ 24 hours length of stay in the ICU, and received a nutrition assessment (7-point SGA) from a dietitian within 48 hours of admission to the ICU.
Who may be able to join
- ≥ 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
Who cannot join
- Nil
About this study
Official title: Association Between Malnutrition and Hospital Mortality and Duration of Intensive Care Unit Admission in the Critically Ill: a Prospective Singapore Cohort Study
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.
Read the 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
- Keywords
- Subjective Global Assessment, Nutritional Status, Hospital Mortality, Length of Stay, Malnutrition
- Medical subject headings
- Critical Illness, Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
Death during hospitalization
Measured: Up to one year after admission to the ICU
ICU length of stay
Duration of the first intensive care unit admission
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, for up to one year after admission to the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Aug 2015
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- JurongHealth
- Sponsor type
- Other government
- Collaborators
- Flinders University, National University of Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213899
- Sponsor's protocol ID
- 2014/00878/2
- Other IDs
- 2014
- Status last verified
- Jul 2017
- First submitted
- 7 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26838530
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Malnutrition and Hospital Mortality and Duration of Intensive Care Unit Admission in the Critically Ill: a Prospective Singapore Cohort Study
- ClinicalTrials.gov ID
- NCT03213899
- Acronym / sponsor ID
- 2014/00878/2
- Conditions
- Critical Illness, Malnutrition
- Keywords
- Subjective Global Assessment, Nutritional Status, Hospital Mortality, Length of Stay, Malnutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- JurongHealthOther government
- Collaborators
- Flinders University, National University of Singapore
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients ≥ 18 years old who had ≥ 24 hours length of stay in the ICU, and received a nutrition assessment (7-point SGA) from a dietitian within 48 hours of admission to the ICU.
Key inclusion criteria (2 listed)
- ≥ 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
Key exclusion criteria (1 listed)
- Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital mortality
Time frame: Up to one year after admission to the ICU
Death during hospitalization
ICU length of stay
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Background: PubMed 26838530Lew 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Malnutrition, run by JurongHealth.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital mortality (time frame: Up to one year after admission to the ICU). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03213899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.