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The Validity of Peripheral Perfusion Index to Predict Fluid Responsiveness

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03805321
Collaborator
(none)
57
Enrollment
1
Location
5.1
Actual Duration (Months)
11.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Fluid therapy is an essential component of the management of patients with acute circulatory failure. Nevertheless, unnecessary administration of fluids in non-responders is harmful. Thus, the concept of fluid responsiveness has been suggested to guide fluid administration in critically ill patients to avoid either over or under-transfusion. The aim of this work is to investigate the ability of peripheral perfusion index to predict the hemodynamic response to mini-fluid challenge in patients with septic shock .

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The concept of fluid responsiveness has been suggested to guide fluid administration in critically ill patients to avoid either over or under-transfusion.

    Several methods have been suggested to detect fluid responsiveness. Mini fluid challenge with concomitant monitoring of stroke volume is one of the most robust methods for pre-load challenge.

    The main foreshortening of mini fluid challenge method is the need for a real-time cardiac output monitor, to track the instantaneous change of stroke vole with changing body position. Finding a surrogate to cardiac output to trace the effect of mini fluid challenge would make the test more applicable without the need for advanced hemodynamic monitors.

    There is a growing interest in the use of perfusion indices in assessment of fluid responsiveness. Perfusion indices are measures for adequacy of oxygen delivery in peripheral tissues; thus, they were hypothesized to be possible surrogates of cardiac output. Peripheral perfusion index represents "the ratio between the pulsatile and non-pulsatile component of the light reaching the pulse oximeter" . Peripheral perfusion index has been considered as a numerical non-invasive measure for peripheral perfusion. PPI has the advantage over other perfusion indices that it a non-invasive, user-friendly monitor.

    The aim of this work is to investigate the ability of peripheral perfusion index to predict the hemodynamic response to mini-fluid challenge in patients with septic shock.

    Mini-fluid challenge test will be performed by infusion of 200 mL Lactated Ringer's solution over 1 minute. Velocity time integral will be monitored using Transthoracic echocardiography at the left ventricular outflow tract at the apical five-chamber view. Cardiac output will be calculated, and the patient will be considered fluid-responder if cardiac output increased by 10% after fluid challenge.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    57 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Validity of Peripheral Perfusion Index to Predict Fluid Responsiveness Using Mini-fluid Challenge Test
    Actual Study Start Date :
    Jan 27, 2019
    Actual Primary Completion Date :
    Jun 25, 2019
    Actual Study Completion Date :
    Jul 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Peripheral perfusion index [2 hours]

      It is a number describing the ratio between pulsatile and non-pulsatile blood flow measured by pulse oximeter. It is measured in percent. with the best value of 20% and the worst value of 0.1%

    Secondary Outcome Measures

    1. Velocity time integral [2 hours]

      it is a parameter measured from Doppler across the left ventricular outflow tract. It is calculated by dividing the blood velocity by time and measured in cm

    2. Mean arterial blood pressure [2 hours]

      Mean arterial blood pressure measured in mmHg

    3. Central venous pressure [2 hours]

      Central venous pressure measured from a central venous catheter. It is measured in cmH2o

    4. Systolic arterial blood pressure [2 hours]

      Systolic arterial blood pressure measured in mmHg

    5. Diastolic arterial blood pressure [2 hours]

      Diastolic arterial blood pressure measured in mmHg

    6. Cardiac output [2 hours]

      The amount of blood pumped by the heart in one minute. it is measured as liters per minute

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Septic shock patients
    Exclusion Criteria:

    • Evident blood loss

    • Peripheral vascular disorders

    • Upper limb injury or burns

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ahmed Mohamed Hasanin Cairo Egypt 11432

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Director: Ahmed Shash, Professor, Head of department of anesthesia, Cairo University, Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Hasanin, Assistant professor of anesthesia and critical care, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03805321
    Other Study ID Numbers:
    • N-138-2018
    First Posted:
    Jan 15, 2019
    Last Update Posted:
    Dec 23, 2020
    Last Verified:
    Dec 1, 2020
    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
    Additional relevant MeSH terms:
    Shock, Septic

    Study Results

    No Results Posted as of Dec 23, 2020