Right Ventricle Dysfunction in Critically Ill Patients

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05975086
Collaborator
(none)
200
12.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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.
    1. Exclusion criteria:

    2. Children below 18 yr.

    3. Patients who could not be scanned within 48h after ICU admission.

    4. 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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Right Ventricle Dysfunction in Critically Ill Patients
    Anticipated Study Start Date :
    Aug 30, 2023
    Anticipated Primary Completion Date :
    Aug 1, 2024
    Anticipated Study Completion Date :
    Sep 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Impact of right ventricle dysfunction in Critically ill patients on short term and long term outcome [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).

    Secondary Outcome Measures

    1. Impact of right ventricle dysfunction in Critically ill patients on short term and long term outcome [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mustafa Shaban Abdelsalam Thabet, Resident doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05975086
    Other Study ID Numbers:
    • RVD
    First Posted:
    Aug 3, 2023
    Last Update Posted:
    Aug 3, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 3, 2023