Biliary Atresia, Hepatic Buffer Response and Sevoflurane

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.

Study Overview

• Status: Completed
• Conditions: Biliary Atresia
• Intervention / Treatment: Drug: 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 Type: Observational
• Enrollment (Actual): 25

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

infants with biliary atresia scheduled for a Kasai procedure

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Biliary Atresia Infants; 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.

Drug: Sevoflurane; general anesthesia with 2% followed by 3% sevoflurane; Other Names: general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
portal blood flow	10 minutes
hepatic arterial blood flow	10 minutes
hepatic blood flow	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	noninvasive blood pressure	5 minutes
renal blood flow		10 minutes
femoral vein blood flow		10 minutes

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: June 3, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (Estimate): June 15, 2015

Study Record Updates

• Last Update Posted (Estimate): June 15, 2015
• Last Update Submitted That Met QC Criteria: June 10, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Biliary Tract Diseases; Bile Duct Diseases; Digestive System Abnormalities; Biliary Atresia; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Sevoflurane
• Other Study ID Numbers: mzk-0003-2011