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

March 23, 2023 updated by: Yimei, Cao, Tianjin First Central Hospital
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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

165

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300192

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: propofol group
Drug: propofol
Intraoperative anesthesia maintenance
Experimental: propofol and desflurane group
Drug: propofol
Intraoperative anesthesia maintenance
Drug: desflurane
Intraoperative anesthesia maintenance
Experimental: desflurane group
Drug: desflurane
Intraoperative anesthesia maintenance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of PARDS
Time Frame: 7 days after LDLT
the definition of PARDS recommended by the 2015 Pediatric Acute Lung Injury Consensus Conference
7 days after LDLT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High mobility group box 1
Time Frame: immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）
Peripheral blood is collected
immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）
Interleukin-6
Time Frame: immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）
Peripheral blood is collected
immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）
Tumor necrosis factor-alpha
Time Frame: immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）
Peripheral blood is collected
immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin First Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 27, 2023

Primary Completion (Anticipated)

October 31, 2023

Study Completion (Anticipated)

October 31, 2023

Study Registration Dates

First Submitted

March 12, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

March 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Desflurane on PARDS after LDLT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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