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

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT03391037

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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 .

Condition or Disease	Intervention/Treatment	Phase
Monitoring During Anesthesia	Diagnostic Test: Internal Jugular Vein Distensibility

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 Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Aug 10, 2017

Actual Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	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.	Diagnostic Test: Internal Jugular Vein Distensibility . 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

Arm

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.

Diagnostic Test: Internal Jugular Vein Distensibility

. 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

Outcome Measures

Primary Outcome Measures

correlation between CVP and IJV distensibility [10 min]
IJV distensibility is the difference between maximum diameter of IJV and minimum diamter in Manchester mode divided by minimum diameter

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mona Ammar, Principal investigaror, Ain Shams University

ClinicalTrials.gov Identifier:

NCT03391037

Other Study ID Numbers:

133/2018

First Posted:

Jan 5, 2018

Last Update Posted:

Jan 5, 2018

Last Verified:

Dec 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 5, 2018