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OpenTrials
Completed

NCT Number: NCT03461523

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.

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Key information

Conditions

ICU Stay & Mortality

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NHTMRI

Cairo, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. ICU stay

    Time frame: average 2 - 4 weeks

    Length of ICU stay in days

  2. Mortality

    Time frame: average 2-4 weeks

    ICU Mortality in days

Secondary outcomes

  1. the need for mechanical ventilation

    Time frame: during ICU stay 2-4 weeks

    notice & register the need for & type of mechanical ventilation; invasive or non invasive & days of ventilation

  2. Duration of mechanical ventilation

    Time frame: 1-4 weeks

    Duration in days

  3. the need for pharmacological support

    Time frame: 1-4 weeks

    notice & register the need for drugs to support the hemodynamics

  4. occurrence of nosocomial infection

    Time frame: 2-28 days

    site of nosocomial infection

  5. Hospital stay

    Time frame: average 2-28days

    Length of hospital stay

  6. Hospital mortality

    Time frame: average 28 days

    mortality

Sponsors and collaborators

Lead sponsor

National Hepatology & Tropical Medicine Research Institute

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Mar 12, 2018
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.