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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05783518
Other study ID # Desflurane on PARDS after LDLT
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date March 27, 2023
Est. completion date October 31, 2023

Study information

Verified date March 2023
Source Tianjin First Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Biliary atresia is a serious congenital anomaly characterized by persistent and progressive cholestatic jaundice. The incidence of biliary atresia is more common in East Asia, especially China, with an incidence of 2 per 10,000 live births. Liver transplantation is the only effective way to treat end-stage liver disease. However, distant organ damage, affecting the heart, brain, kidneys, lungs, and intestines, is still an important factor affecting the long-term survival of children after surgery. Desflurane is a volatile anesthetic commonly used in surgery. In order to observe the effect of desflurane on the incidence of early postoperative pediatric acute respiratory distress syndrome (PARDS) with biliary atresia who underwent living donor liver transplantation, and explore the related mechanism, a total of 165 infant patients underwent living liver transplantation due to biliary atresia from March 2023 to October 2023 are included in our single-center prospective study. They are randomly divided into propofol group (n=55), propofol and desflurane group (n=55) and desflurane group (n=55) according to the difference of intraoperative anesthesia maintenance. Gender, age, height, weight, PELD scores and other preoperative basic data are recorded. Operation time, anhepatic time and intraoperative blood loss volume are recorded. The basic information of liver donors are also recorded. Postoperative mechanical ventilation time, ICU stay time, tacrolimus concentration, total length of hospital stay and mortality during hospitalization are recorded. According to the the definition of PARDS recommended by the 2015 Pediatric Acute Lung Injury Consensus Conference is used as the diagnostic and grading criteria for postoperative PARDS, and the incidence and grading of PARDS within the first seven days after surgery are evaluated in the three groups. Peripheral blood is collected immediately after anesthesia induction, 30min after reperfusion and at the end of surgery to detect serum levels of HMGB1, IL-6 and TNF-α by enzyme linked immunosorbent assay (ELISA).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 165
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 3 Months to 36 Months
Eligibility Inclusion Criteria: - The diagnosis was biliary atresia - Living donors were either the father or the mother - 3months =age = 36 months Exclusion Criteria: - The preoperative diagnosis was not biliary atresia - The donor was not a parent - Age <3months or>36 months - The patient had perinatal disease or congenital cardiopulmonary deformity - The patient had acute respiratory infection before surgery - The patient had hepatopulmonary syndrome - Retransplantation

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
desflurane
Intraoperative anesthesia maintenance
propofol
Intraoperative anesthesia maintenance

Locations

Country Name City State
China TianjinFCH Tianjin Tianjin
China TianjinFCH Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Tianjin First Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Chung PHY, Zheng S, Tam PKH. Biliary atresia: East versus west. Semin Pediatr Surg. 2020 Aug;29(4):150950. doi: 10.1016/j.sempedsurg.2020.150950. Epub 2020 Jul 23. — View Citation

Karakayali H, Sevmis S, Ozcelik U, Ozcay F, Moray G, Torgay A, Arslan G, Haberal M. Liver transplantation for biliary atresia. Transplant Proc. 2008 Jan-Feb;40(1):231-3. doi: 10.1016/j.transproceed.2007.11.015. — View Citation

Lendahl U, Lui VCH, Chung PHY, Tam PKH. Biliary Atresia - emerging diagnostic and therapy opportunities. EBioMedicine. 2021 Dec;74:103689. doi: 10.1016/j.ebiom.2021.103689. Epub 2021 Nov 12. — View Citation

Schilling T, Kozian A, Kretzschmar M, Huth C, Welte T, Buhling F, Hedenstierna G, Hachenberg T. Effects of propofol and desflurane anaesthesia on the alveolar inflammatory response to one-lung ventilation. Br J Anaesth. 2007 Sep;99(3):368-75. doi: 10.1093/bja/aem184. Epub 2007 Jul 9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary the incidence of PARDS the definition of PARDS recommended by the 2015 Pediatric Acute Lung Injury Consensus Conference 7 days after LDLT
Secondary High mobility group box 1 Peripheral blood is collected immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery(up to 30minutes)
Secondary Interleukin-6 Peripheral blood is collected immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery(up to 30minutes)
Secondary Tumor necrosis factor-alpha Peripheral blood is collected immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery(up to 30minutes)
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