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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05783518
Acronym
EDPARDSLDLTR
Enrollment
165
Registered
2023-03-24
Start date
2023-03-27
Completion date
2023-10-31
Last updated
2023-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Atresia, Desflurane, Pediatric Acute Respiratory Distress Syndrome

Keywords

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

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).

Interventions

DRUGdesflurane

Intraoperative anesthesia maintenance

DRUGpropofol

Intraoperative anesthesia maintenance

Sponsors

Tianjin First Central Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Months to 36 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the incidence of PARDS7 days after LDLTthe definition of PARDS recommended by the 2015 Pediatric Acute Lung Injury Consensus Conference

Secondary

MeasureTime frameDescription
High mobility group box 1immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery(up to 30minutes)Peripheral blood is collected
Interleukin-6immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery(up to 30minutes)Peripheral blood is collected
Tumor necrosis factor-alphaimmediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery(up to 30minutes)Peripheral blood is collected

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026