Pediatric Liver TransplantationNCT05825703
Incidence and Risk Factors of Prolonged Post-Operative Mechanical Ventilation
An observational study of Pediatric Liver Transplantation, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The primary goal of the study is to identify incidence and risk factors for PPMV in pediatric patients undergoing liver transplantation. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Pediatric Liver Transplantation
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 30 Apr 2023to 30 May 2023
- Phase
- Observational
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: All Pediatric patients aged <17 years underwent liver transplant between 2010- March 2022 in the institute will be included in the study.
Who may be able to join
- All Pediatric patients aged <17 years underwent liver transplant between 2010- March 2022 in the institute will be included in the study.
Who cannot join
- Patients who required mechanical ventilation during the 48 hr preceding surgery.
- Older than 18 yr at the time of transplantation
- Acute liver failure
- Acute on chronic liver failure
Trial locations and contacts
1 site in 1 country.
India1 site
ILBS
New Delhi, 110070
MANOJ K P, MD, 9008144931, manojmannu972@gmail.com
UDIT DHINGRA, MD, 8861987684, uddh1989@gmail.com
About this study
Official title: Incidence and Risk Factors of Prolonged Post-Operative Mechanical Ventilation in Pediatric Liver Transplant Recipients: A Retrospective Study
The primary goal of the study is to identify incidence and risk factors for PPMV in pediatric patients undergoing liver transplantation.
Read the detailed description
The vast majority of children undergoing orthotopic liver transplantation (OLT) are maintained on mechanical ventilation (MV) in the immediate postoperative period. Reasons for this practice include concerns about graft function, postoperative respiratory depression from opioids, preexisting malnutrition, and organ-recipient size mismatch as well as poor cooperation of young children with postoperative instructions. With current improvements in the perioperative care, there is increasing drive towards early extubation in both adults and children.
Although many children require only a few days of MV following OLT, some require a more prolonged course. In general, prolonged postoperative mechanical ventilation (PPMV) in intensive care unit (ICU) patients is marker of severe adverse events and is associated with higher morbidity and mortality as well as extraordinary resource utilization. Patients requiring PPMV have survived the acute phase of surgery but spend an increased amount of time in the ICU, consume about 50% of all intensive care unit (ICU) resources and are more likely to die. Consequently, investigating the incidence and factors predisposing to PPMV following liver transplant is an important area of research with potential to reduce cost of care and improve long-term outcome of patients.
To our knowledge, factors associated with PPMV following pediatric liver transplantation have not been comprehensively characterized.
- Conditions
- Pediatric Liver Transplantation
- Keywords
- Pediatric Liver Transplantation, Post-operative Mechanical Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PPMV | GROUP OF PATIENT POPULATION WHO HAD PROLONGED POST-OPERATIVE MECHANICAL VENTILATION | |
| NON PPMV | GROUP OF PATIENT POPULATION WHO DID NOT HAVE PROLONGED POST-OPERATIVE MECHANICAL VENTILATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with post-operative mechanical ventilation
To identify risk factors for prolonged post-operative mechanical ventilation (PPMV) in pediatric patients undergoing liver transplantation.
Measured: 24 hours
Secondary outcomes (4)
Incidence of PPMV
To identify risk INCIDENCE for prolonged post-operative mechanical ventilation (PPMV) in pediatric patients undergoing liver transplantation.
Measured: 24 hours
total duration of icu stay and length of stay in hospital.
To identify effect of prolonged post-operative mechanical ventilation (PPMV) on total duration of icu stay and length of stay in hospital.
Measured: From the day of admission to discharge or death, whichever comes first,upto 12 weeks
incidence of tracheostomy/re-intubation
To identify incidence of tracheostomy/re-intubation of prolonged post-operative mechanical ventilation (PPMV).
Measured: 28 days post-op
incidence of 28 day mortality
To identify incidence of 28 day mortality prolonged post-operative mechanical ventilation (PPMV) group.
Measured: 28 days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start30 Apr 2023 (estimated)
- Primary completion15 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825703
- Sponsor's protocol ID
- ILBS/DOA/2022/23757/978
- Status last verified
- Sep 2022
- First submitted
- 1 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of Prolonged Post-Operative Mechanical Ventilation in Pediatric Liver Transplant Recipients: A Retrospective Study
- ClinicalTrials.gov ID
- NCT05825703
- Acronym / sponsor ID
- ILBS/DOA/2022/23757/978
- Conditions
- Pediatric Liver Transplantation
- Keywords
- Pediatric Liver Transplantation, Post-operative Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 30 Apr 2023 (estimated)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 24 Apr 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.
The primary goal of the study is to identify incidence and risk factors for PPMV in pediatric patients undergoing liver transplantation.
Detailed description
The vast majority of children undergoing orthotopic liver transplantation (OLT) are maintained on mechanical ventilation (MV) in the immediate postoperative period. Reasons for this practice include concerns about graft function, postoperative respiratory depression from opioids, preexisting malnutrition, and organ-recipient size mismatch as well as poor cooperation of young children with postoperative instructions. With current improvements in the perioperative care, there is increasing drive towards early extubation in both adults and children.
Although many children require only a few days of MV following OLT, some require a more prolonged course. In general, prolonged postoperative mechanical ventilation (PPMV) in intensive care unit (ICU) patients is marker of severe adverse events and is associated with higher morbidity and mortality as well as extraordinary resource utilization. Patients requiring PPMV have survived the acute phase of surgery but spend an increased amount of time in the ICU, consume about 50% of all intensive care unit (ICU) resources and are more likely to die. Consequently, investigating the incidence and factors predisposing to PPMV following liver transplant is an important area of research with potential to reduce cost of care and improve long-term outcome of patients.
To our knowledge, factors associated with PPMV following pediatric liver transplantation have not been comprehensively characterized.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPMV | – | –GROUP OF PATIENT POPULATION WHO HAD PROLONGED POST-OPERATIVE MECHANICAL VENTILATION |
| NON PPMV | – | –GROUP OF PATIENT POPULATION WHO DID NOT HAVE PROLONGED POST-OPERATIVE MECHANICAL VENTILATION |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All Pediatric patients aged <17 years underwent liver transplant between 2010- March 2022 in the institute will be included in the study.
Key inclusion criteria (1 listed)
- All Pediatric patients aged <17 years underwent liver transplant between 2010- March 2022 in the institute will be included in the study.
Key exclusion criteria (4 listed)
- Patients who required mechanical ventilation during the 48 hr preceding surgery.
- Older than 18 yr at the time of transplantation
- Acute liver failure
- Acute on chronic liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with post-operative mechanical ventilation
Time frame: 24 hours
To identify risk factors for prolonged post-operative mechanical ventilation (PPMV) in pediatric patients undergoing liver transplantation.
4 secondary outcomes
Incidence of PPMV
Time frame: 24 hours
total duration of icu stay and length of stay in hospital.
Time frame: From the day of admission to discharge or death, whichever comes first,upto 12 weeks
incidence of tracheostomy/re-intubation
Time frame: 28 days post-op
incidence of 28 day mortality
Time frame: 28 days post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Liver Transplantation, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 1 inclusion and 4 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 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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.
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?
Number of participants with post-operative mechanical ventilation (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2023.