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Clinical Trials/NCT03461523
NCT03461523
Completed
Not Applicable

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??

National Hepatology & Tropical Medicine Research Institute1 site in 1 country517 target enrollmentFebruary 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ICU Stay & Mortality
Sponsor
National Hepatology & Tropical Medicine Research Institute
Enrollment
517
Locations
1
Primary Endpoint
ICU stay
Status
Completed
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
February 10, 2018
End Date
February 19, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ICU

Fellow of intensive care medicine

National Hepatology & Tropical Medicine Research Institute

Eligibility Criteria

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).

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • the need for pharmacological support(1-4 weeks)
  • occurrence of nosocomial infection(2-28 days)
  • Hospital stay(average 2-28days)
  • Hospital mortality(average 28 days)
  • Duration of mechanical ventilation(1-4 weeks)
  • the need for mechanical ventilation(during ICU stay 2-4 weeks)

Study Sites (1)

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