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Completed

NCT Number: NCT04261816

Early Extubation and Postoperative Complications After Liver Transplantation

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.

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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

West China Hospital

Chengdu, Sichuan, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

extubation in the operating room

Procedure

Patients who underwent liver transplantation early extubation in the operating room immediately following liver transplantation

extubation in the ICU

Procedure

Patients who underwent liver transplantation extubation in the ICU following liver transplantation

Primary outcomes

  1. The incidence of a composite of 30-day all-cause mortality, AKI and moderate to severe pulmonary complications.

    Time frame: through study completion, an average of 1 year

    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

Secondary outcomes

  1. The incidence of moderate to severe infectious complications

    Time frame: 30 days

    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

  2. The incidence of re-intubation.

    Time frame: 30 days

    Reintubation was defined as intubation after extubation of a patient who had been initially tracheal intubated under general anaesthesia

  3. The length of hospital stay

    Time frame: through study completion, an average of 1 year

    Length of hospital stay is the duration of a single episode of hospitalization

  4. The length of ICU stay

    Time frame: through study completion, an average of 1 year

    Length of ICU stay is the duration of a single episode of ICU hospitalization

  5. The total hospital cost

    Time frame: 30 days

    The total hospital cost

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2020
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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