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Pleth Variability Index for Directed Fluid Optimization in Donors in Living Donor Liver Transplantation

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ClinicalTrials.gov Identifier: NCT03921125
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Amr M Hilal Abdou, Ain Shams University

Study Description
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Brief Summary:
In this Study we are trying to validate the accuracy of Plethogram variability index in predicting fluid responsiveness compared to pulse pressure variation in donors of liver transplantation

Condition or disease Intervention/treatment
Fluid Response Device: Massimo for Pleth variability index

Detailed Description:

The liver transplantation program at Ain Shams University Hospitals relies on related living donors. Extra care during anesthetic management of the donor is warranted because of clear ethical considerations.

This prospective observational study was performed after obtaining approval from the ethical committee of the Ain Shams University FWA R 53/2018. Sample of 40 healthy ASA I or II donors' candidate for right lobe hepatectomy for living donor liver transplantation (LDLT) were included and consent was taken. Conventional form of anesthesia was induced with left radial arterial line inserted for invasive blood pressure monitoring, frequent blood gases and lactate sampling, and measuring the PPV, Right insertion of internal jugular vein line for CVP measurement. Fluid management in the form of ringer acetate 3-5 ml/kg/hr recruitment of the patients (Hypovolemic donors) depends on the presenting signs that led the anesthesiologist to decide if the patient's volume status was hypovolemic and in need for fluid replacement without presence of surgical mechanical compression on the IVC or Liver during dissection phase. These diagnostic criteria for volume assessment were heart rate (HR) more than 100 beats/min, systolic arterial blood pressure (SAP) less than 90 mmHg.

Assessment of Hemodynamics during periods of Hypovolemia After exclusion of any surgical mechanical compression, all enrolled hypovolemic patients had left radial arterial line measuring PPV using Drager Monitor and a pulse oximeter measuring PVI using Device Masimo. This device measures the perfusion index which is the indicator of the amplitude of the signal of PVI, confirmation of the wave signal should be obtained from any finger, fingers should be kept warm before test is done. Hypovolemic patients were given a fluid bolus in the form of ringer acetate 5 ml / Kg over 10 minutes. At the end of volume expansion another recorded PPV and PVI are done. Primary outcome was the correlation between PPV and PVI before and after fluid resuscitation

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Accuracy of Pleth Variability Index for Directed Fluid Optimization in Donors in Living Donor Liver Transplantation
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : September 20, 2019
Estimated Study Completion Date : October 20, 2019

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Responders Device: Massimo for Pleth variability index
To assess fluid response
Non responders


Outcome Measures
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Primary Outcome Measures :
  1. Correlation between PPV and PVI before and after fluid resuscitation. [ Time Frame: 6 hours ]
    Assess accuracy of device in fluid response


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Sample of 40 healthy ASA I or II donors' candidate for right lobe hepatectomy for living donor liver transplantation
Criteria

Inclusion Criteria:

  • Sample of 40 healthy ASA I or II donors' candidate for right lobe hepatectomy for living donor liver transplantation

Exclusion Criteria:

  • Lack of consent
Contacts and Locations
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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): NCT03921125


Contacts
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Contact: Amr M Hilal Abdou, MD +201001479037 amr_hilal@med.asu.edu.eg

Locations
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Egypt
Ain Shams University Hospitals Recruiting
Cairo, Egypt
Contact: Fathy Tash, MD    +20226857539      
Principal Investigator: Amr M Hilal Abdou, MD         
Sub-Investigator: Mohamed M Kamal         
Ain shams university hospitals Recruiting
Cairo, Egypt
Contact: Amr M Hilal Abdou, MD         
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Amr Hilal abdou Ain shams University, Faculty of medicine
More Information
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Responsible Party: Amr M Hilal Abdou, Lecturer of Anesthesia and Intensive care, Ain Shams University
ClinicalTrials.gov Identifier: NCT03921125    
Other Study ID Numbers: R 53/2018
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Decided to share the IPD
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Amr M Hilal Abdou, Ain Shams University:
Living donors
PVI
PPV
Fluids
Response