- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03391037
Internal Jugular Vein Distensibility in Assessment of Fluid Responsiveness in Donors of Living Donor Liver Transplantation
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
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.