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??

ICU Stay & Mortality Clinical Trial

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??

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03461523
• Other study ID #: BMI
• Status: Completed
• Start date: February 10, 2018
• Est. completion date: February 19, 2021

Study information

• Verified date: February 2021
• Source: National Hepatology & Tropical Medicine Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 517
• Est. completion date: February 19, 2021
• Est. primary completion date: June 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Critical Illness
• ICU Stay & Mortality

Locations

Country	Name	City	State
Egypt	NHTMRI	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Hepatology & Tropical Medicine Research Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU stay	Length of ICU stay in days	average 2 - 4 weeks
Primary	Mortality	ICU Mortality in days	average 2-4 weeks
Secondary	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
Secondary	Duration of mechanical ventilation	Duration in days	1-4 weeks
Secondary	the need for pharmacological support	notice & register the need for drugs to support the hemodynamics	1-4 weeks
Secondary	occurrence of nosocomial infection	site of nosocomial infection	2-28 days
Secondary	Hospital stay	Length of hospital stay	average 2-28days
Secondary	Hospital mortality	mortality	average 28 days