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Non Invasive Evaluation of Fluid Responsiveness in Septic Patient

Sponsor
Benha University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05310942
Collaborator
(none)
60
Enrollment
1
Location
12.5
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to evaluate the accuracy of fluid responsiveness assessment with non-invasive cardiometry compared to ultrasound guided inferior vena cava (IVC) collapsibility for management of critically ill septic patients with hemodynamic instability.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Prospective Randomized observational comparative single blinded study will be conducted at intensive care unit at Benha University Hospitals after obtaining approval of the ethical committee and informed written consent from first degree relatives will be issued. The blindness will be performed to the patients.

    The study will be conducted according to CONSORT 2010 statement. Enrolment of eligible patients will occur within 8 h of meeting the criteria for septic shock. All patients will be randomized using the computer-generated software of randomization and sealed closed envelopes to allocate them to one of two groups (30 patients each). Routine measurements and investigations will be taken at admission to intensive care unit; history, vital signs, routine laboratory investigation.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Comparing the Non Invasive Cardiometry With Ultrasound Guided Inferior Vena Cava Collapsibility for Evaluation of Fluid Responsiveness in Septic Patient; Randomized Clinical Trials
    Actual Study Start Date :
    Dec 17, 2021
    Actual Primary Completion Date :
    Jan 3, 2022
    Anticipated Study Completion Date :
    Jan 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    A

    The fluid management of patients in this group will be assessed by IVC collapsibility index (IVC CI) calculated by ultrasound through maximum IVC diameter - minimum IVC diameter divided by maximum diameter then multiplied by 100. If it is less than 50% means that the patient is volume non- depleted while if it is more than 50% means the reverse.
    B

    All patients in this group with sepsis will be evaluated by the electrical cardiometry monitor.

    Outcome Measures

    Primary Outcome Measures

    1. Fluid responsiveness [2 years]

      The study primary outcome will be the cardiac index determined by the non-invasive cardiometry in correlation with ultrasound guided IVC collapsibility index to determine which is more effective in prediction of fluid responsiveness.

    Secondary Outcome Measures

    1. total infused fluid from ICU arrival till the goal is achieved [2 years]

    2. total dose of vasopressor and inotrope taken during ICU stay period [2 years]

    3. time to weaning of vasopressors and inotropes [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. ASA class I and II

    2. Age 18-65 years old of both genders.

    3. Fulfilment criteria of sepsis as defined according to the standard Surviving Sepsis Campaign criteria using the Sequential (sepsis-related) Organ Failure Assessment (SOFA) score (SOFA score ≥ 2 indicated organ dysfunction).

    4. Patients within 8 h of meeting the criteria for septic shock.

    Exclusion Criteria:

    1. Lack of consent

    2. Age below 18 and above 65 years old.

    3. acute coronary syndrome

    4. major cardiac dysrhythmia,

    5. valvular or congenital heart disease

    6. Massive bilateral pleural effusion

    7. Severe anaemia

    8. End-stage kidney disease (ESKD) patients with Creatinine clearance (CrCl) <50ml/min.

    9. Child B and Child C hepatic patients

    10. impaired systolic function according to the ejection fraction (EF) (EF < 40% indicated impaired systolic function)

    11. Severe ARDS (acute respiratory distress syndrome).

    12. Tense ascites

    13. Mechanical ventilation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Banhā Egypt 13518

    Sponsors and Collaborators

    • Benha University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ebtehal Shaheen, assisstant lecturer at faculty of medicine, Benha University
    ClinicalTrials.gov Identifier:
    NCT05310942
    Other Study ID Numbers:
    • MD17-12-2021
    First Posted:
    Apr 5, 2022
    Last Update Posted:
    Apr 19, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ebtehal Shaheen, assisstant lecturer at faculty of medicine, Benha University
    fluid responsiveness
    cardiometry
    IVC collapsibility
    Additional relevant MeSH terms:
    Shock, Septic

    Study Results

    No Results Posted as of Apr 19, 2022