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??

The purpose of the study is to evaluate the hypothesis of poor clinical outcomes in critically ill patients that are having abnormal BMI.

Study Overview

• Status: Completed
• Conditions: ICU Stay & Mortality

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 Type: Observational
• Enrollment (Actual): 517

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • NHTMRI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients will be excluded if they have stayed in ICU ≤24 hours and underweight (BMI<18.5).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU stay	Length of ICU stay in days	average 2 - 4 weeks
Mortality	ICU Mortality in days	average 2-4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the need for mechanical ventilation	notice & register the need for & type of mechanical ventilation; invasive or non invasive & days of ventilation	during ICU stay 2-4 weeks
Duration of mechanical ventilation	Duration in days	1-4 weeks
the need for pharmacological support	notice & register the need for drugs to support the hemodynamics	1-4 weeks
occurrence of nosocomial infection	site of nosocomial infection	2-28 days
Hospital stay	Length of hospital stay	average 2-28days
Hospital mortality	mortality	average 28 days

Collaborators and Investigators

• Sponsor: National Hepatology & Tropical Medicine Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2018
• Primary Completion (Actual): June 24, 2020
• Study Completion (Actual): February 19, 2021

Study Registration Dates

• First Submitted: March 3, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 19, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: BMI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No