MalnutritionNCT06047054
Incidence Rate and Risk Factors of Malnutrition in ICU
An observational study of Malnutrition, run by Zagazig University at 1 site in Egypt.
Trial summary
To assess the incidence of malnutrition in surgical Intensive Care Unit by NUTRIC score. To determine the different risk factors of malnutrition Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to Oct 2024
- 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
- Adult, Older adult
Study population: All cases who will admitted to the surgical intensive care unit
Who may be able to join
- Adult patients who will be admitted to surgical ICU.
- Both sexes.
Who cannot join
- • Referral from another hospital or other ICU
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine - Zagazig University
Zagazig, 44519
Naglaa Abdelhaleem, MD, 01003103036, nogaahmedkareem.fa@gmail.com
About this study
Official title: Incidence Rate and Risk Factors of Malnutrition in Patients Admitted to Surgical Intensive Care Unit
To assess the incidence of malnutrition in surgical Intensive Care Unit by NUTRIC score. To determine the different risk factors of malnutrition
Read the detailed description
To assess the incidence of malnutrition in surgical Intensive Care Unit by NUTRIC score. To determine the different risk factors of malnutrition by assessment of the type of nutrition, caloric adequacy, and actual caloric intake, laboratory Investigations twice weekly
- Conditions
- Malnutrition
- Medical subject headings
- Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess incidence rate of malnutrition in ICU
Assessment of nutrition state by (NUTRIC) Score on admission and weekly until patient discharge or death
Measured: From the date of randomization until the date of ICU discharge or death, assessed up to 4 months
Secondary outcomes (1)
Correlation of risk factors with malnutrition in ICU
correlation of risk factors such as: age, comorbidities, and sepsis with malnutrition
Measured: From the date of randomization until the date of ICU discharge or death, assessed up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 May 2023
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
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 MalnutritionStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Naglaa Fathy Abdelhaleem Abdelhaleem, Zagazig University
- Investigators
- Naglaa Abdelhaleem, MD, Principal investigator, Faculty of medicine, Zagazig University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047054
- Sponsor's protocol ID
- IRB #7074
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2023
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence Rate and Risk Factors of Malnutrition in Patients Admitted to Surgical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06047054
- Acronym / sponsor ID
- IRB #7074
- Conditions
- Malnutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 May 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 21 Sep 2023 (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.
To assess the incidence of malnutrition in surgical Intensive Care Unit by NUTRIC score. To determine the different risk factors of malnutrition
Detailed description
To assess the incidence of malnutrition in surgical Intensive Care Unit by NUTRIC score. To determine the different risk factors of malnutrition by assessment of the type of nutrition, caloric adequacy, and actual caloric intake, laboratory Investigations twice weekly
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All cases who will admitted to the surgical intensive care unit
Key inclusion criteria (2 listed)
- Adult patients who will be admitted to surgical ICU.
- Both sexes.
Key exclusion criteria (1 listed)
- • Referral from another hospital or other ICU
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
Assess incidence rate of malnutrition in ICU
Time frame: From the date of randomization until the date of ICU discharge or death, assessed up to 4 months
Assessment of nutrition state by (NUTRIC) Score on admission and weekly until patient discharge or death
1 secondary outcome
Correlation of risk factors with malnutrition in ICU
Time frame: From the date of randomization until the date of ICU discharge or death, assessed up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- 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.
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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.
Naglaa Abdelhaleem, MD principal investigator
Faculty of medicine, Zagazig University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Zagazig University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Bahrawy, M.B.B. Ch (01202040703, ahmedelbahrawy28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess incidence rate of malnutrition in ICU (time frame: From the date of randomization until the date of ICU discharge or death, assessed up to 4 months). 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 NCT06047054, 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 27 Aug 2024.