Effect of Desflurane on Pediatric Acute Respiratory Distress Syndrome After Living Donor Liver Transplant Recipients

Biliary Atresia Clinical Trial

— EDPARDSLDLTR  

Official title:

Effect of Desflurane on Pediatric Acute Respiratory Distress Syndrome After Living Donor Liver Transplant Recipients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05783518
• Other study ID #: Desflurane on PARDS after LDLT
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Acute Lung Injury
• Biliary Atresia
• Desflurane
• Pediatric Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

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)