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

NCT ID: NCT03921125

Last Updated: 2019-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-09

Study Completion Date

2019-10-20

Brief Summary

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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

Detailed Description

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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

Conditions

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Fluid Response

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Responders

Massimo for Pleth variability index

Intervention Type DEVICE

To assess fluid response

Non responders

No interventions assigned to this group

Interventions

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Massimo for Pleth variability index

To assess fluid response

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Amr M Hilal Abdou

Lecturer of Anesthesia and Intensive care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amr Hilal abdou

Role: PRINCIPAL_INVESTIGATOR

Ain shams University, Faculty of medicine

Locations

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Ain Shams University Hospitals

Cairo, , Egypt

Site Status RECRUITING

Ain shams university hospitals

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amr M Hilal Abdou, MD

Role: CONTACT

+201001479037

Facility Contacts

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Fathy Tash, MD

Role: primary

+20226857539

Amr M Hilal Abdou, MD

Role: primary

Other Identifiers

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R 53/2018

Identifier Type: -

Identifier Source: org_study_id

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