ICU Stay & MortalityNCT03461523
Observational, Prospective, Single-center Study: Should Body Mass Index (BMI) be Added to the Scoring Criteria of Hepatic Critically Ill Patients in Intensive Care Unit??
An observational study of ICU Stay & Mortality, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.
Trial summary
The purpose of the study is to evaluate the hypothesis of poor clinical outcomes in critically ill patients that are having abnormal BMI. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- ICU Stay & Mortality
- How many people
- 517 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2018to 19 Feb 2021
- How long will I take part?
- 15 Days
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients that will be admitted to ICU will be categorized into; BMI < 18.5Kg/m2 =underweight, BMI between 18.5-24.9Kg/m2 = normal weight, while BMI between 25-29.9Kg/m2 = overweight \& obese = BMI ≥ 30Kg/m2
Who may be able to join
- Patients who are admitted to the intensive care unit of National Hepatology \& Tropical Medicine Research Institute (NHTMRI) for medical \& surgical indications during the period from February 2018 to December 2020.
Who cannot join
- Patients will be excluded if they have stayed in ICU ≤24 hours and underweight (BMI<18.5).
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to evaluate the hypothesis of poor clinical outcomes in critically ill patients that are having abnormal BMI.
Read the detailed description
All demographic data will be obtained including the patients' age, sex, body mass index (BMI) \& categorized into; BMI < 18.5Kg/m2 = underweight, BMI between 18.5-24.9Kg/m2 = normal weight, while BMI between 25-29.9Kg/m2 = overweight \& obese = BMI ≥ 30Kg/m2, associated co-morbidities (diabetes mellitus, hypertension, chronic renal failure, cancer\& chronic liver disease), the cause of admission to ICU, Sequential Organ Failure Assessment (SOFA), nutritional risk screening (NRS) on admission \& discharge, prior cardiac arrest, previous ICU admission within 6months, nosocomial infection, organ failure e.g. cardiovascular, respiratory, renal \& organic support requirement e.g. hemodynamic support, mechanical ventilation, renal replacement therapy (RRT).
- Conditions
- ICU Stay & Mortality
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU stay
Length of ICU stay in days
Measured: average 2 - 4 weeks
Mortality
ICU Mortality in days
Measured: average 2-4 weeks
Secondary outcomes (6)
the need for mechanical ventilation
notice \& register the need for \& type of mechanical ventilation; invasive or non invasive \& days of ventilation
Measured: during ICU stay 2-4 weeks
Duration of mechanical ventilation
Duration in days
Measured: 1-4 weeks
the need for pharmacological support
notice \& register the need for drugs to support the hemodynamics
Measured: 1-4 weeks
occurrence of nosocomial infection
site of nosocomial infection
Measured: 2-28 days
Hospital stay
Length of hospital stay
Measured: average 2-28days
Hospital mortality
mortality
Measured: average 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start10 Feb 2018
- Primary completion24 Jun 2020
- Study completion19 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU Stay & MortalityStudies 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
- 517 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- National Hepatology & Tropical Medicine Research Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ICU, National Hepatology & Tropical Medicine Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461523
- Sponsor's protocol ID
- BMI
- Status last verified
- Feb 2021
- First submitted
- 3 Mar 2018
- Last updated
- 21 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Prospective, Single-center Study: Should Body Mass Index (BMI) be Added to the Scoring Criteria of Hepatic Critically Ill Patients in Intensive Care Unit??
- ClinicalTrials.gov ID
- NCT03461523
- Acronym / sponsor ID
- BMI
- Conditions
- ICU Stay & Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- National Hepatology & Tropical Medicine Research InstituteOther government
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 19 Feb 2021 (actual)
- First posted
- 12 Mar 2018 (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.
The purpose of the study is to evaluate the hypothesis of poor clinical outcomes in critically ill patients that are having abnormal BMI.
Detailed description
All demographic data will be obtained including the patients' age, sex, body mass index (BMI) \& categorized into; BMI < 18.5Kg/m2 = underweight, BMI between 18.5-24.9Kg/m2 = normal weight, while BMI between 25-29.9Kg/m2 = overweight \& obese = BMI ≥ 30Kg/m2, associated co-morbidities (diabetes mellitus, hypertension, chronic renal failure, cancer\& chronic liver disease), the cause of admission to ICU, Sequential Organ Failure Assessment (SOFA), nutritional risk screening (NRS) on admission \& discharge, prior cardiac arrest, previous ICU admission within 6months, nosocomial infection, organ failure e.g. cardiovascular, respiratory, renal \& organic support requirement e.g. hemodynamic support, mechanical ventilation, renal replacement therapy (RRT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that will be admitted to ICU will be categorized into; BMI < 18.5Kg/m2 =underweight, BMI between 18.5-24.9Kg/m2 = normal weight, while BMI between 25-29.9Kg/m2 = overweight \& obese = BMI ≥ 30Kg/m2
Key inclusion criteria (1 listed)
- Patients who are admitted to the intensive care unit of National Hepatology \& Tropical Medicine Research Institute (NHTMRI) for medical \& surgical indications during the period from February 2018 to December 2020.
Key exclusion criteria (1 listed)
- Patients will be excluded if they have stayed in ICU ≤24 hours and underweight (BMI<18.5).
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
ICU stay
Time frame: average 2 - 4 weeks
Length of ICU stay in days
Mortality
Time frame: average 2-4 weeks
ICU Mortality in days
6 secondary outcomes
the need for mechanical ventilation
Time frame: during ICU stay 2-4 weeks
Duration of mechanical ventilation
Time frame: 1-4 weeks
the need for pharmacological support
Time frame: 1-4 weeks
occurrence of nosocomial infection
Time frame: 2-28 days
Hospital stay
Time frame: average 2-28days
Hospital mortality
Time frame: average 28 days
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 21 Feb 2021.
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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.
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 ICU Stay & Mortality, run by National Hepatology & Tropical Medicine Research Institute 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 1 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 21 Feb 2021. 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?
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?
ICU stay (time frame: average 2 - 4 weeks). 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?
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 21 Feb 2021.