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??

Completed

• Conditions: ICU Stay & Mortality

• Registration Number: NCT03461523
• Lead Sponsor: National Hepatology & Tropical Medicine Research Institute

Brief Summary

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 Timeline

• Study Start: 2018-02-10
• Study First Submitted: 2018-03-03
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-12
• Primary Completion: 2020-06-24
• Status Verified: 2021-02
• Study Completion: 2021-02-19
• Last Update Submitted: 2021-02-19
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 517

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ICU stay	average 2 - 4 weeks	Length of ICU stay in days
Mortality	average 2-4 weeks	ICU Mortality in days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NHTMRI; 🇪🇬 Cairo, Egypt