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

Primary Purpose

Pediatric Acute Respiratory Distress Syndrome, Desflurane, Biliary Atresia

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
desflurane
propofol
Sponsored by
Tianjin First Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric Acute Respiratory Distress Syndrome focused on measuring Pediatric Acute Respiratory Distress Syndrome, Living Donor Liver Transplant, Desflurane, Biliary atresia

Eligibility Criteria

3 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • TianjinFCH
  • TianjinFCH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

propofol group

propofol and desflurane group

desflurane group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

High mobility group box 1
Peripheral blood is collected
Interleukin-6
Peripheral blood is collected
Tumor necrosis factor-alpha
Peripheral blood is collected

Full Information

First Posted
March 12, 2023
Last Updated
March 23, 2023
Sponsor
Tianjin First Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05783518
Brief Title
Effect of Desflurane on Pediatric Acute Respiratory Distress Syndrome After Living Donor Liver Transplant Recipients
Acronym
EDPARDSLDLTR
Official Title
Effect of Desflurane on Pediatric Acute Respiratory Distress Syndrome After Living Donor Liver Transplant Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 27, 2023 (Anticipated)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin First Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Acute Respiratory Distress Syndrome, Desflurane, Biliary Atresia
Keywords
Pediatric Acute Respiratory Distress Syndrome, Living Donor Liver Transplant, Desflurane, Biliary atresia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
propofol group
Arm Type
Experimental
Arm Title
propofol and desflurane group
Arm Type
Experimental
Arm Title
desflurane group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
desflurane
Intervention Description
Intraoperative anesthesia maintenance
Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Description
Intraoperative anesthesia maintenance
Primary Outcome Measure Information:
Title
the incidence of PARDS
Description
the definition of PARDS recommended by the 2015 Pediatric Acute Lung Injury Consensus Conference
Time Frame
7 days after LDLT
Secondary Outcome Measure Information:
Title
High mobility group box 1
Description
Peripheral blood is collected
Time Frame
immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery(up to 30minutes)
Title
Interleukin-6
Description
Peripheral blood is collected
Time Frame
immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery(up to 30minutes)
Title
Tumor necrosis factor-alpha
Description
Peripheral blood is collected
Time Frame
immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery(up to 30minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
TianjinFCH
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300192
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yimei Cao
Phone
8613426335223
Email
caoyimei@yeah.net
Facility Name
TianjinFCH
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300192
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34781099
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.
Results Reference
background
PubMed Identifier
32861448
Citation
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.
Results Reference
background
PubMed Identifier
18261594
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.
Results Reference
background
PubMed Identifier
17621602
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.
Results Reference
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Effect of Desflurane on Pediatric Acute Respiratory Distress Syndrome After Living Donor Liver Transplant Recipients

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