Validity of Mini Fluid Challenge Post Liver Transplantation

Not Applicable

Completed

• Conditions: Liver Transplantation
• Interventions: Diagnostic Test: mini fluid challenge

• Registration Number: NCT03396159
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

our study aim to assess the validity of using mini fluid challenge to assess the volaemic status of patients after liver transplantation

Detailed Description

After approval of institutional ethical committee and after informed patient consent, patients fulfilling criteria will be involved. Upon ICU admission, patients will be connected to full monitoring and confirming patient hemodynamic stability and no active bleeding through drains. Patients will be in supine position and baseline readings will be recorded. Fluid responsiveness will be assessed with mini fluid challenge by 150 ml of albumin 5% given over 1 minute. After fluid administration stroke volume (SV) assessed by trans thoracic echo (TTE) and other hemodynamic parameters will be recorded. Remaining 350 ml of albumin 5% will be continued over 14 minute to have total volume given 500 ml. after fluid administration SV and other parameters will be recorded. The fluid challenge will be given intravenously via a specific wide pore venous line. Fluid responsiveness will be defined as an increase in the SV by 15% after the infusion of fluid.

TT Echo Examination:

A single LVOT diameter will be measured for each patient as the distance between the inflection points at the base of the aortic valve cusps from the left parasternal long axis view during systole.

Assuming a circular cross section, the LVOT area will be calculated from the LVOT diameter as:

π X (LVOT diameter/ 2)2 = (LVOT diameter)2 X 0.785 Pulse wave Doppler sampling cursor will be placed in the middle of the LVOT immediately proximal to the aortic valve in 5 chamber apical view.

The sonographer manually will trace the velocity-time envelope (VTI). SV values will be calculated by multiplying VTI by cross sectional area.

Study Timeline

• Study First Submitted: 2017-12-25
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-10
• Study Start: 2018-01-30
• Primary Completion: 2018-05-20
• Study Completion: 2018-05-20
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-20
• Last Update Posted: 2018-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients post liver transplantation.
• ASA III- IV
• Age > 18 years

Exclusion Criteria

• Age less than 18 years.
• Patient with fulminant liver failure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mini fluid challenge	mini fluid challenge	mini fluid will be given and stroke volume will be assessed before and after

Primary Outcome Measures

Name	Time	Method
stroke volume	1 minute after mini fluid administration	assessed by trans thoracic echo

Secondary Outcome Measures

Name	Time	Method
heart rate	baseline 10 minutes after intensive care admission, 1 minute after mini fluid challenge and 1 minute after 500 ml of fluid administration
stroke volume	baseline 10 minutes after intensive care admission and 1 minute after 500 ml of fluid administration	assessed by trans thoracic echo
mean arterial blood pressure	baseline 10 minutes after intensive care admission and 1 minute after 500 ml of fluid administration

Trial Locations

Locations (1)

Kasr Alainy Hospital , Faculty of Medicine; 🇪🇬 Cairo, Egypt