Early Extubation and Postoperative Complications After Liver Transplantation

Liver Transplantation Clinical Trial

Official title:

Association Between Early Extubation and Postoperative Complications After Liver Transplantation: A Retrospective Propensity Score-matched Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04261816
• Other study ID #: 2020-014
• Status: Completed
• Start date: January 15, 2020
• Est. completion date: April 15, 2020

Study information

• Verified date: April 2021
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective cohort study. Patients who underwent liver transplantation from January 1, 2016 to December 31, 2019 were admitted to the study and divided into two groups. Operating room extubation group: early extubation in the operating room immediately following liver transplantation. Intensive care unit (ICU) extubation group: delay extubation in the ICU following liver transplantation. The primary objectives were to compare the incidence of composite outcome between the two groups. secondary objectives were to compare outcomes such as length of stay, hospital length of stay, and total cost between the two groups.

Description:

Patients who underwent liver transplantation from January 1, 2016 to December 31, 2019 were admitted to the study. Inclusion criteria: (1) adult patients (age ≥ 18 years), (2) undergoing liver transplantation. Exclusion criteria were the following: (1) re-transplantation; (2) multi-visceral transplantation; (3) intraoperative death; (4) severe encephalopathy (West Haven criteria III or IV); (5) those who had preoperative mechanical ventilation; (6) incomplete clinical data. The primary objectives was a composite of 30-day all-cause mortality, in-hospital AKI, or in-hospital moderate to severe pulmonary complications. Complications were defined and graded as mild, moderate, or severe as described by European Perioperative Clinical Outcome definitions and were included if they occurred in hospital after surgery. The secondary objectives included in-hospital moderate to severe infectious complications, unplanned reintubation rates, ICU and postoperative hospital lengths of stay, and total hospital cost.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (age = 18 years)

• Undergoing liver transplantation

Exclusion Criteria:

• Re-transplantation

• Multi-organ transplants

• Intra-operative deaths

• severe encephalopathy (West Haven criteria III or IV)

• patients who had preoperative mechanical ventilation or fulminant hepatic failure

• Incomplete clinical data

Related Conditions & MeSH terms

• Liver Transplantation
• Postoperative Complications

Intervention

Procedure:
• extubation in the operating room
Patients who underwent liver transplantation early extubation in the operating room immediately following liver transplantation
• extubation in the ICU
Patients who underwent liver transplantation extubation in the ICU following liver transplantation

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of a composite of 30-day all-cause mortality, AKI and moderate to severe pulmonary complications.	Complications were defined and graded as mild, moderate, or severe as described by European Perioperative Clinical Outcome definitions and were included if they occurred in hospital after surgery	through study completion, an average of 1 year
Secondary	The incidence of moderate to severe infectious complications	Complications were defined and graded as mild, moderate, or severe as described by European Perioperative Clinical Outcome definitions and were included if they occurred in hospital after surgery	30 days
Secondary	The incidence of re-intubation.	Reintubation was defined as intubation after extubation of a patient who had been initially tracheal intubated under general anaesthesia	30 days
Secondary	The length of hospital stay	Length of hospital stay is the duration of a single episode of hospitalization	through study completion, an average of 1 year
Secondary	The length of ICU stay	Length of ICU stay is the duration of a single episode of ICU hospitalization	through study completion, an average of 1 year
Secondary	The total hospital cost	The total hospital cost	30 days