Validity of Mini Fluid Challenge Post Liver Transplantation

NCT ID: NCT03396159

Last Updated: 2018-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-30
• Study Completion Date: 2018-05-20

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.

Conditions

Liver Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

mini fluid challenge

mini fluid will be given and stroke volume will be assessed before and after

Group Type: EXPERIMENTAL

mini fluid challenge

Intervention Type: DIAGNOSTIC_TEST

mini fluid challenge will be given to diagnose if patient is need fluid resuscitation or not

Interventions

mini fluid challenge

mini fluid challenge will be given to diagnose if patient is need fluid resuscitation or not

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Elayashy Mohamed Ahmed Hassan

lecturer of anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ahmed mohamed mokhtar, M.D

Role: STUDY_DIRECTOR

kasralainy faculty of medicine, Cairo university

Locations

Kasr Alainy Hospital , Faculty of Medicine

Cairo, , Egypt

Countries

Egypt

References

Bechstein WO, Neuhaus P. [Bleeding problems in liver surgery and liver transplantation]. Chirurg. 2000 Apr;71(4):363-8. doi: 10.1007/s001040051066. German.

Reference Type: BACKGROUND

PMID: 10840602 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 3392792 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11690706 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15370457 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30987597 (View on PubMed)

Other Identifiers

N-6-2018

Identifier Type: -

Identifier Source: org_study_id