Validity of Mini Fluid Challenge Post Liver Transplantation

Liver Transplantation Clinical Trial

Official title:

Validity of Mini Fluid Challenge to Assess Fluid Responsiveness Post Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03396159
• Other study ID #: N-6-2018
• Status: Completed
• Phase: N/A
• Start date: January 30, 2018
• Est. completion date: May 20, 2018

Study information

• Verified date: July 2018
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 20, 2018
• Est. primary completion date: May 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients post liver transplantation.

• ASA III- IV

• Age > 18 years

Exclusion Criteria:

• Age less than 18 years.

• Patient with fulminant liver failure.

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Diagnostic Test:
• mini fluid challenge
mini fluid challenge will be given to diagnose if patient is need fluid resuscitation or not

Locations

Country	Name	City	State
Egypt	Kasr Alainy Hospital , Faculty of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Bechstein WO, Neuhaus P. [Bleeding problems in liver surgery and liver transplantation]. Chirurg. 2000 Apr;71(4):363-8. Review. German. — View Citation

Henriksen JH. Volume adaptation in chronic liver disease: on the static and dynamic location of water, salt, protein and red cells in cirrhosis. Scand J Clin Lab Invest. 2004;64(6):523-33. Review. — View Citation

Kiszka-Kanowitz M, Henriksen JH, Møller S, Bendtsen F. Blood volume distribution in patients with cirrhosis: aspects of the dual-head gamma-camera technique. J Hepatol. 2001 Nov;35(5):605-12. — View Citation

Leavy JA, Weil MH, Rackow EC. 'Lactate washout' following circulatory arrest. JAMA. 1988 Aug 5;260(5):662-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stroke volume	assessed by trans thoracic echo	1 minute after mini fluid administration
Secondary	heart rate		baseline 10 minutes after intensive care admission, 1 minute after mini fluid challenge and 1 minute after 500 ml of fluid administration
Secondary	stroke volume	assessed by trans thoracic echo	baseline 10 minutes after intensive care admission and 1 minute after 500 ml of fluid administration
Secondary	mean arterial blood pressure		baseline 10 minutes after intensive care admission and 1 minute after 500 ml of fluid administration