NCT03461523

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
517

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2021

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

2.4 years

First QC Date

March 3, 2018

Last Update Submit

February 19, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • ICU stay

    Length of ICU stay in days

    average 2 - 4 weeks

  • Mortality

    ICU Mortality in days

    average 2-4 weeks

Secondary Outcomes (6)

  • the need for mechanical ventilation

    during ICU stay 2-4 weeks

  • Duration of mechanical ventilation

    1-4 weeks

  • the need for pharmacological support

    1-4 weeks

  • occurrence of nosocomial infection

    2-28 days

  • Hospital stay

    average 2-28days

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHTMRI

Cairo, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Days
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow of intensive care medicine

Study Record Dates

First Submitted

March 3, 2018

First Posted

March 12, 2018

Study Start

February 10, 2018

Primary Completion

June 24, 2020

Study Completion

February 19, 2021

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations