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Biliary Atresia, Hepatic Buffer Response and Sevoflurane

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ClinicalTrials.gov Identifier: NCT02471209
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : June 15, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Biliary Atresia 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.

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : January 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

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 Name: general anesthesia




Primary Outcome Measures :
  1. portal blood flow [ Time Frame: 10 minutes ]
  2. hepatic arterial blood flow [ Time Frame: 10 minutes ]
  3. hepatic blood flow [ Time Frame: 10 minutes ]

Secondary Outcome Measures :
  1. blood pressure [ Time Frame: 5 minutes ]
    noninvasive blood pressure

  2. renal blood flow [ Time Frame: 10 minutes ]
  3. femoral vein blood flow [ Time Frame: 10 minutes ]


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Ages Eligible for Study:   1 Month to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
infants with biliary atresia scheduled for a Kasai procedure
Criteria

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
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Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT02471209    
Other Study ID Numbers: mzk-0003-2011
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: June 15, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Biliary Atresia
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Digestive System Abnormalities
Congenital Abnormalities
Sevoflurane
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General