Biliary Atresia, Hepatic Buffer Response and Sevoflurane

Completed

• Conditions: Biliary Atresia
• Interventions: Drug: Sevoflurane

• Registration Number: NCT02471209
• Lead Sponsor: Children's Hospital of Fudan University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2014-01
• Study Completion: 2014-02
• Status Verified: 2015-06
• Study First Submitted: 2015-06-03
• Study First Submitted QC: 2015-06-10
• Last Update Submitted: 2015-06-10
• Study First Posted: 2015-06-15
• Last Update Posted: 2015-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biliary Atresia Infants	Sevoflurane	Twenty-five infants diagnosed with Biliary Atresia and undergoing surgery were included in the study (age range 1-3 months). Inclusion criteria were 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. Infants were excluded if they had concomitant cardiovascular or abdominal organ malformations.

Primary Outcome Measures

Name	Time	Method
hepatic blood flow	10 minutes
portal blood flow	10 minutes
hepatic arterial blood flow	10 minutes

Secondary Outcome Measures

Name	Time	Method
renal blood flow	10 minutes
blood pressure	5 minutes	noninvasive blood pressure
femoral vein blood flow	10 minutes