Biliary Atresia, Hepatic Buffer Response and Sevoflurane

Biliary Atresia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471209
• Other study ID #: mzk-0003-2011
• Status: Completed
• Phase: N/A
• First received: June 3, 2015
• Last updated: June 10, 2015
• Start date: January 2012
• Est. completion date: February 2014

Study information

• Verified date: June 2015
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

To evaluate the effects of sevoflurane on hepatic blood flow (HBF) and hepatic arterial buffer response (HABR) in infants with obstructive jaundice by Doppler ultrasound.Twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were enrolled. portal vein blood flow (PBF), hepatic arterial blood flow (HABF) and hepatic blood flow (HBF) were measured by Doppler ultrasound before induction, and after inhalation of 2 and 3% sevoflurane.

Description:

Children suffering from hepatobiliary disease also have an hepatic arterial buffer response (HABR) with reduced portal vein blood flow (PBF) and compensatory increases in hepatic arterial blood flow (HABF) which can help maintain hepatic blood flow (HBF). For infants with obstructive hepatobiliary disease, reduced HBF may affect drug metabolism and increase the risk of respiratory depression during analgesia, which can be life-threatening.

To evaluate the effects of sevoflurane on HBF and HABR in infants with obstructive jaundice by Doppler ultrasound.Twenty-five infants with biliary atresia (1-3 months-of-age) scheduled for a Kasai procedure were enrolled. PBF, HABF and HBF were measured by Doppler ultrasound before induction, and after inhalation of 2 and 3% sevoflurane.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 3 Months

Eligibility

Inclusion Criteria:

• persistent yellow skin or sclera, pale stool (in severe cases, clay-like), and hepatomegaly;

• increased serum bilirubin (progressively or no decline after increase), increased total bilirubin (TBil) dominated by increased direct bilirubin (DBil) (>60%);

• elevated liver enzymes;

• ultrasound confirmation of poor gallbladder filling and signs of liver fibrosis;

• with radionuclide imaging confirmation of obstructed biliary excretion

Exclusion Criteria:

• concomitant cardiovascular or abdominal organ malformations

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Biliary Atresia

Intervention

Drug:
• Sevoflurane
general anesthesia with 2% followed by 3% sevoflurane

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	portal blood flow		10 minutes	No
Primary	hepatic arterial blood flow		10 minutes	No
Primary	hepatic blood flow		10 minutes	No
Secondary	blood pressure	noninvasive blood pressure	5 minutes	No
Secondary	renal blood flow		10 minutes	No
Secondary	femoral vein blood flow		10 minutes	No