Right Ventricle Dysfunction in Critically Ill Patients

July 27, 2023 updated by: Mustafa Shaban Abdelsalam Thabet, Assiut University

To assess prevalence of right ventricle dysfunction in critically ill patient. To assess impact of RV dysfunction on short term (ICU stay, hospital stay, or mortality ≤30 days) and long term outcome (>30 days).

To assess the accuracy of different parameters of RV dysfunction.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

  1. Inclusion criteria:

    - Adult patients who admitted to critical care of Internal medicine department after obtaining consent during the period between august 2023 and august 2024.

  2. Exclusion criteria:

    1. Children below 18 yr.
    2. Patients who could not be scanned within 48h after ICU admission.

  3. Sample Size Calculation:

    200 patients 2.4.4 Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ):

    Beside history and clinical examination , The following data will be obtained:

    Demographic and historical data: the patient age, sex, history of hypertension, chronic obstructive pulmonary disease, IHD, cause of critical care unit admission and indication of mechanical ventilation( PEEP).

    Clinical examination data: pulse, blood pressure, respiratory rate, temperature , BMI, and thorough chest, cardiac examination data will be obtained.

    Volume state of the patient: CVP measurement, input and output fluid chart. APACHE IV score, Use of vasopressors, Use of sedatives. Investigation : Arterial blood gas analysis, pulse oxygen saturation, CBC, and renal function test and electrolytes, serum lactate and troponin.

    12 lead ECG for RV strain patterns.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

- Adult patients who admitted to critical care of Internal medicine department after obtaining consent during the period between august 2023 and august 2024.

Description

Inclusion Criteria:

  • Adult patients who admitted to critical care of Internal medicine department after obtaining consent during the period between august 2023 and august 2024.

Exclusion Criteria:

  1. Children below 18 yr.
  2. Patients who could not be scanned within 48h after ICU admission.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of right ventricle dysfunction in Critically ill patients on short term and long term outcome
Time Frame: Baseline
To assess prevalence of right ventricle dysfunction in critically ill patient. To assess impact of RV dysfunction on short term (ICU stay, hospital stay, or mortality ≤30 days) and long term outcome (>30 days).
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of right ventricle dysfunction in Critically ill patients on short term and long term outcome
Time Frame: Baseline
To assess prevalence of right ventricle dysfunction in critically ill patient. To assess impact of RV dysfunction on short term (ICU stay, hospital stay, or mortality ≤30 days) and long term outcome (>30 days).
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

August 30, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

July 27, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVD

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.

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