NCT03396159

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

January 30, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2018

Completed
Last Updated

July 23, 2018

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

December 25, 2017

Last Update Submit

July 20, 2018

Conditions

Liver Transplantation

Keywords

liver transplantationmini fluid challenge

Outcome Measures

Primary Outcomes (1)

  • stroke volume

    assessed by trans thoracic echo

    1 minute after mini fluid administration

Secondary Outcomes (3)

  • 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

  • mean arterial blood pressure

    baseline 10 minutes after intensive care admission and 1 minute after 500 ml of fluid administration

Study Arms (1)

mini fluid challenge

EXPERIMENTAL

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

Diagnostic Test: mini fluid challenge

Interventions

mini fluid challengeDIAGNOSTIC_TEST

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

mini fluid challenge

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy Hospital , Faculty of Medicine

Cairo, Egypt

Location

Related Publications (5)

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

    PMID: 10840602BACKGROUND

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

    PMID: 3392792BACKGROUND

  • 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.

    PMID: 11690706BACKGROUND

  • 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.

    PMID: 15370457BACKGROUND

  • 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.

    PMID: 30987597DERIVED

Study Officials

  • ahmed mohamed mokhtar, M.D

    kasralainy faculty of medicine, Cairo university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia

Study Record Dates

First Submitted

December 25, 2017

First Posted

January 10, 2018

Study Start

January 30, 2018

Primary Completion

May 20, 2018

Study Completion

May 20, 2018

Last Updated

July 23, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)