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

Fluid Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03921125
• Other study ID #: R 53/2018
• Status: Recruiting
• Start date: October 9, 2018
• Est. completion date: October 20, 2019

Study information

• Verified date: May 2019
• Source: Ain Shams University
• Contact: Amr M Hilal Abdou, MD
• Phone: +201001479037
• Email: amr_hilal[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 20, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Fluid Response

Intervention

Device:
• Massimo for Pleth variability index
To assess fluid response

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo
Egypt	Ain shams university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between PPV and PVI before and after fluid resuscitation.	Assess accuracy of device in fluid response	6 hours