Pediatric Acute Respiratory Distress SyndromePhase 4EDPARDSLDLTRNCT05783518
Effect of Desflurane on Pediatric Acute Respiratory Distress Syndrome After Living Donor Liver Transplant Recipients
A Phase 4 study testing desflurane and propofol in people with Pediatric Acute Respiratory Distress Syndrome and Desflurane, run by Tianjin First Central Hospital at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 3 to 36 months
- Conditions the study is for
- Pediatric Acute Respiratory Distress Syndrome, Desflurane, Biliary Atresia
- What is being tested?
- desflurane and propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 2 sitesChina
- Study dates
- 27 Mar 2023to 31 Oct 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The diagnosis was biliary atresia
- Living donors were either the father or the mother
- 3months ≤age ≤ 36 months
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
TianjinFCH
Tianjin, Tianjin Municipality, 300192
Yimei Cao, 8613426335223, caoyimei@yeah.net
TianjinFCH
Tianjin, Tianjin Municipality, 300192
About this study
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).
- Being tested
- desflurane, propofol
- Keywords
- Pediatric Acute Respiratory Distress Syndrome, Living Donor Liver Transplant, Desflurane, Biliary atresia
- Medical subject headings
- Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desfluraneDrug
Intraoperative anesthesia maintenance
propofolDrug
Intraoperative anesthesia maintenance
| Study group | Role | What they receive |
|---|---|---|
| propofol group | Experimental | Not described Receives: Drug: propofol |
| propofol and desflurane group | Experimental | Not described Receives: Drug: desflurane; Drug: propofol |
| desflurane group | Experimental | Not described Receives: Drug: desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of PARDS
the definition of PARDS recommended by the 2015 Pediatric Acute Lung Injury Consensus Conference
Measured: 7 days after LDLT
Secondary outcomes (3)
High mobility group box 1
Peripheral blood is collected
Measured: immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）
Interleukin-6
Peripheral blood is collected
Measured: immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）
Tumor necrosis factor-alpha
Peripheral blood is collected
Measured: immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start27 Mar 2023 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pediatric Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin First Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yimei, Cao, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783518
- Sponsor's protocol ID
- Desflurane on PARDS after LDLT
- Acronym
- EDPARDSLDLTR
- Status last verified
- Mar 2023
- First submitted
- 12 Mar 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34781099Chung 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.
PubMed 32861448Karakayali 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.
PubMed 18261594Schilling 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.
PubMed 17621602
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Desflurane on Pediatric Acute Respiratory Distress Syndrome After Living Donor Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT05783518
- Acronym / sponsor ID
- EDPARDSLDLTR / Desflurane on PARDS after LDLT
- Keywords
- Pediatric Acute Respiratory Distress Syndrome, Living Donor Liver Transplant, Desflurane, Biliary atresia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Tianjin First Central HospitalUniversity, hospital or other
- Study start
- 27 Mar 2023 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| propofol group | Experimental | Drug: propofol |
| propofol and desflurane group | Experimental | Drug: desflurane, Drug: propofol |
| desflurane group | Experimental | Drug: desflurane |
Who may qualify
- Ages
- 3 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The diagnosis was biliary atresia
- Living donors were either the father or the mother
- 3months ≤age ≤ 36 months
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| desfluraneIntraoperative anesthesia maintenance | Drug | desflurane group, propofol and desflurane group |
| propofolIntraoperative anesthesia maintenance | Drug | propofol and desflurane group, propofol group |
Primary outcome
the incidence of PARDS
Time frame: 7 days after LDLT
the definition of PARDS recommended by the 2015 Pediatric Acute Lung Injury Consensus Conference
3 secondary outcomes
High mobility group box 1
Time frame: 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）
Tumor necrosis factor-alpha
Time frame: immediately after anesthesia induction, 30minutes after reperfusion and at the end of surgery（up to 30minutes）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Background: PubMed 34781099Lendahl 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.
- Background: PubMed 32861448Chung 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.
- Background: PubMed 18261594Karakayali 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.
- Background: PubMed 17621602Schilling 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing desflurane and propofol in people with Pediatric Acute Respiratory Distress Syndrome and Desflurane, run by Tianjin First Central Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of PARDS (time frame: 7 days after LDLT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05783518, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.