COVID-19 Patients Admitted to the ICU

March 24, 2021 updated by: Waleed burhamah, Ministry of Health, Kuwait

Prognostic Factors and Predictors of Mortality in COVID-19 Patients Admitted to the ICU. An Aid for Triage, Counseling, and Resource Allocation

A retrospective analysis of the adult COVID-19 patients admitted to the ICU. A chart review will be conducted and multiple baseline characteristics, demographics, and treatments given will be recorded.

Variables collected will include Age, Gender, BMI, Smoking status, Past medical history, Vital signs on admission, symptoms on admission, duration of symptoms, laboratory results on admission, treatment given. Treatment options will include (Steroids, plasma exchange, IVIG, antibiotics, mode of respiratory support).

Primary outcomes will include; Death, duration of ICU stay, duration of mechanical ventilation, in-hospital complications.

A regression model will be used to predict poor prognostic factors. Inclusion criteria: patients with confirmed PCR results for COVID-19 AND require ICU admission. Exclusion criteria: those with negative results, pediatric patients and those not requiring ICU admission.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Outside U.S./Canada
      • Kuwait, Outside U.S./Canada, Kuwait, 00000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to the hospital and suspected of having the COVID-19 virus. Patients who are positive on a PCR test are usually traiged to be managed on the wards Vs ICU (Intensive care unit). This is based on a number of parameters; including but not limited to The severity of the symptoms, vital signs, lab results, co-morbidities, age.

Description

Inclusion Criteria:

  • Adults
  • Positive PCR test for COVID-19
  • Require admission to ICU

Exclusion Criteria:

  • Pediatric patients\
  • Any patient not requiring admission to ICU

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1: Admitted to ICU and died during the hospital stay.
no intervention will be administered, this is a retrospective observational study.
Group 2: Admitted to ICU was were discharged.
no intervention will be administered, this is a retrospective observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 30 day mortality
Death Vs No Death
30 day mortality
Duration of ICU stay
Time Frame: 30 days
Duration of ICU stay
30 days
Duration of mechanical ventilation
Time Frame: 30 days
The duration the patient required support from a mechanical ventilator
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-Hospital complications
Time Frame: 30 days
Wether patients developed in hospital complications.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 24, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Covid19

Clinical Trials on no intervention will be administered, this is a retrospective observational study.

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