Clinical trial NCT03396159: Validity of Mini Fluid Challenge Post Liver Transplantation
Official title: Validity of Mini Fluid Challenge to Assess Fluid Responsiveness Post Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplantation
Keywords: liver transplantation
mini fluid challenge
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: stroke volume
timeFrame: 1 minute after mini fluid administration
Secondary outcomes:
measure: heart rate
timeFrame: baseline 10 minutes after intensive care admission, 1 minute after mini fluid challenge and 1 minute after 500 ml of fluid administration
measure: stroke volume
timeFrame: baseline 10 minutes after intensive care admission and 1 minute after 500 ml of fluid administration
measure: mean arterial blood pressure
timeFrame: baseline 10 minutes after intensive care admission and 1 minute after 500 ml of fluid administration
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy Hospital , Faculty of Medicine
Study officials:
affiliation: kasralainy faculty of medicine, Cairo university
name: ahmed mohamed mokhtar, M.D
role: STUDY_DIRECTOR
References:
citation: Bechstein WO, Neuhaus P. [Bleeding problems in liver surgery and liver transplantation]. Chirurg. 2000 Apr;71(4):363-8. doi: 10.1007/s001040051066. German.
citation: Leavy JA, Weil MH, Rackow EC. 'Lactate washout' following circulatory arrest. JAMA. 1988 Aug 5;260(5):662-4.
citation: Kiszka-Kanowitz M, Henriksen JH, Moller 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. doi: 10.1016/s0168-8278(01)00175-1.
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. doi: 10.1080/00365510410002788.
citation: Mukhtar A, Awad M, Elayashy M, Hussein A, Obayah G, El Adawy A, Ahmed M, Dahab HA, Hasanin A, Elfouly A, Abdo M, Abdelaal A, Teboul JL. Validity of mini-fluid challenge for predicting fluid responsiveness following liver transplantation. BMC Anesthesiol. 2019 Apr 13;19(1):56. doi: 10.1186/s12871-019-0728-4.