Internal Jugular Vein Distensibility in Assessment of Fluid Responsiveness in Donors of Living Donor Liver Transplantation

December 29, 2017 updated by: Mona Ammar, Ain Shams University

Egypt has a very high prevalence of HCV and a high morbidity and mortality from chronic liver disease, cirrhosis, and hepatocellular carcinoma. Approximately 20% of Egyptian blood donors are anti-HCV positive. Egypt has higher rates of HCV than neighboring countries as well as other countries in the world with comparable socioeconomic conditions and hygienic standards for invasive medical, dental, or paramedical procedures.

Donor safety is on the top of our priorities as a team and it is widely recognized intraopertively during hepatectomy, there are several potential risks during the Perioperative period .

Study Overview

Detailed Description

to a conclusion that intraoperative fluid management aids to the reduction of the intraoperative bleeding during the procedure, adequate and guided fluid management is considered one of the important strategies to reduce the blood loss besides of the other anesthetic techniques like hemodilution, normovolemia, cell salvage usage , high Stroke volume variation (SVV) method ,and low CVP technique , the last method is considered the most applicable, simpler, and cost effective technique which could be easier to be performed.

Study Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Prospective blinded observational study

Description

Inclusion Criteria:

  • age of 20 years . candidate for donor right lobe hepatectomy for LDLT . volume assessment diagnosed as hypovolemia intraopertively by the anesthesiologist.

Exclusion Criteria:

  • inability to scan IJV secondary to surgical dressing, hematoma formation after trial or placement of CVP catheter on left side.

inability for proper positioning.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention
diagnostic criteria for volume assessment were heart rate (HR), mean arterial blood pressure (MABP), central venous pressure (CVP), and urine output hourly (UOP) in ml/hr. During period of hypovolemia, all enrolled patients had left IJV scanned (T0) and measured by one anesthesiologist experienced in point-of-care ultrasound. This point-of-care anesthesiologist is not involved in the anesthetic management of the patient and blinded to the volume status of the patient values. Hypovolemic patients were given a fluid bolus in the form of ringer acetate 5 ml / Kg. Ultrasonic and hemodynamic measurements are reassessed 10 minutes (T 10) after the fluid resuscitation.
. 40 donor candidates for right lobe hepatectomy for living donor liver transplantation were enrolled. During period of hypovolemia (T0) left IJV scanned and measured. After a given fluid bolus in the form of ringer acetate 5 ml / Kg. ultrasonic and hemodynamic measurements were reassessed 10 minutes (T 10) after the fluid resuscitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between CVP and IJV distensibility
Time Frame: 10 min
IJV distensibility is the difference between maximum diameter of IJV and minimum diamter in Manchester mode divided by minimum diameter
10 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

August 10, 2017

Study Completion (ACTUAL)

October 1, 2017

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria

December 29, 2017

First Posted (ACTUAL)

January 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 5, 2018

Last Update Submitted That Met QC Criteria

December 29, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 133/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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