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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05825703
Other study ID # ILBS/DOA/2022/23757/978
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 30, 2023
Est. completion date May 30, 2023

Study information

Verified date September 2022
Source Institute of Liver and Biliary Sciences, India
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary goal of the study is to identify incidence and risk factors for PPMV in pediatric patients undergoing liver transplantation.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date May 30, 2023
Est. primary completion date May 15, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility Inclusion Criteria: - All Pediatric patients aged <17 years underwent liver transplant between 2010- March 2022 in the institute will be included in the study. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
India ILBS New Delhi

Sponsors (1)

Lead Sponsor Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24 hours
Secondary Incidence of PPMV To identify risk INCIDENCE for prolonged post-operative mechanical ventilation (PPMV) in pediatric patients undergoing liver transplantation. 24 hours
Secondary 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. From the day of admission to discharge or death, whichever comes first,upto 12 weeks
Secondary incidence of tracheostomy/re-intubation To identify incidence of tracheostomy/re-intubation of prolonged post-operative mechanical ventilation (PPMV). 28 days post-op
Secondary incidence of 28 day mortality To identify incidence of 28 day mortality prolonged post-operative mechanical ventilation (PPMV) group. 28 days post-op
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