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

NCT05783518 | Unknown Phase 4 DMC

• 1 other identifier: Desflurane on PARDS after LDLT
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Pediatric Acute Respiratory Distress Syndrome; Desflurane; Biliary Atresia

Keywords

Pediatric Acute Respiratory Distress Syndrome; Living Donor Liver Transplant; Desflurane; Biliary atresia

Outcome Measures

Primary Outcomes (1)

• the incidence of PARDS

  the definition of PARDS recommended by the 2015 Pediatric Acute Lung Injury Consensus Conference

  7 days after LDLT

Secondary Outcomes (3)

• High mobility group box 1

  immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）

• Interleukin-6

  immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）

• Tumor necrosis factor-alpha

  immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）

Study Arms (3)

propofol group

EXPERIMENTAL

Drug: propofol

propofol and desflurane group

EXPERIMENTAL

Drug: desflurane; Drug: propofol

desflurane group

EXPERIMENTAL

Drug: desflurane

Interventions

desflurane DRUG

Intraoperative anesthesia maintenance

desflurane group; propofol and desflurane group

propofol DRUG

Intraoperative anesthesia maintenance

propofol and desflurane group; propofol group

Eligibility Criteria

• Age: 3 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The diagnosis was biliary atresia
• Living donors were either the father or the mother
• months ≤age ≤ 36 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin First Central Hospital: lead

Study Sites (2)

TianjinFCH

Tianjin, Tianjin Municipality, 300192, China

Location

TianjinFCH

Tianjin, Tianjin Municipality, 300192, China

Location

Related Publications (4)

• 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.

  PMID: 34781099 BACKGROUND

• 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.

  PMID: 32861448 BACKGROUND

• 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.

  PMID: 18261594 BACKGROUND

• 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.

  PMID: 17621602 BACKGROUND

MeSH Terms

Conditions

Biliary Atresia

Interventions

Desflurane; Propofol

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The First Central Clinical College of Tianjin Medical University

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: March 24, 2023
• Study Start: March 27, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

CN (2)