Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validity of Mini Fluid Challenge Post Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03396159
Recruitment Status : Completed
First Posted : January 10, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Elayashy Mohamed Ahmed Hassan, 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

Condition or disease Intervention/treatment Phase
Liver Transplantation Diagnostic Test: mini fluid challenge Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validity of Mini Fluid Challenge to Assess Fluid Responsiveness Post Liver Transplantation
Actual Study Start Date : January 30, 2018
Actual Primary Completion Date : May 20, 2018
Actual Study Completion Date : May 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mini fluid challenge
mini fluid will be given and stroke volume will be assessed before and after
Diagnostic Test: mini fluid challenge
mini fluid challenge will be given to diagnose if patient is need fluid resuscitation or not




Primary Outcome Measures :
  1. stroke volume [ Time Frame: 1 minute after mini fluid administration ]
    assessed by trans thoracic echo


Secondary Outcome Measures :
  1. heart rate [ Time Frame: baseline 10 minutes after intensive care admission, 1 minute after mini fluid challenge and 1 minute after 500 ml of fluid administration ]
  2. stroke volume [ Time Frame: baseline 10 minutes after intensive care admission and 1 minute after 500 ml of fluid administration ]
    assessed by trans thoracic echo

  3. mean arterial blood pressure [ Time Frame: baseline 10 minutes after intensive care admission and 1 minute after 500 ml of fluid administration ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03396159


Locations
Layout table for location information
Egypt
Kasr Alainy Hospital , Faculty of Medicine
Cairo, Egypt
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
Layout table for investigator information
Study Director: ahmed mohamed mokhtar, M.D kasralainy faculty of medicine, Cairo university

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Mohamed Elayashy Mohamed Ahmed Hassan, lecturer of anesthesia, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03396159     History of Changes
Other Study ID Numbers: N-6-2018
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohamed Elayashy Mohamed Ahmed Hassan, Kasr El Aini Hospital:
liver transplantation
mini fluid challenge