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The Validity of Peripheral Perfusion Index to Predict Fluid Responsiveness

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ClinicalTrials.gov Identifier: NCT03805321
Recruitment Status : Completed
First Posted : January 15, 2019
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Hasanin, Cairo University

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
Septic Shock

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.

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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 : January 27, 2019
Actual Primary Completion Date : June 25, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock




Primary Outcome Measures :
  1. Peripheral perfusion index [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 2 hours ]
    Mean arterial blood pressure measured in mmHg

  3. Central venous pressure [ Time Frame: 2 hours ]
    Central venous pressure measured from a central venous catheter. It is measured in cmH2o

  4. Systolic arterial blood pressure [ Time Frame: 2 hours ]
    Systolic arterial blood pressure measured in mmHg

  5. Diastolic arterial blood pressure [ Time Frame: 2 hours ]
    Diastolic arterial blood pressure measured in mmHg

  6. Cardiac output [ Time Frame: 2 hours ]
    The amount of blood pumped by the heart in one minute. it is measured as liters per minute



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will include septic shock patients undergoing fluid resuscitation. Patients will be enrolled during evaluation of fluid responsiveness.
Criteria

Inclusion Criteria:

  • Septic shock patients

Exclusion Criteria:

  • Evident blood loss
  • Peripheral vascular disorders
  • Upper limb injury or burns

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805321


Locations
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Egypt
Ahmed Mohamed Hasanin
Cairo, Egypt, 11432
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Ahmed Shash, Professor Head of department of anesthesia, Cairo University, Egypt
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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: January 15, 2019    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Septic
Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock