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NCT Number: NCT06922916

Perioperative Risk Factors Related to the Prognosis of Lung Transplantation: A Retrospective Study

This study analyzes patients who underwent lung transplantation at the First Affiliated Hospital of Zhejiang University from 2017 to 2024, focusing on anesthesia's impact on post-op results. It gathers patient data from hospital and Mediston systems, with main focus on in-hospital complications and secondary focus on ICU stay, post-op hospitalization, mortality, and intubation time. The research aims to deepen understanding of anesthetic management's role in lung transplant outcomes and guide improvements in perioperative anesthesia protocols.

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Key information

Conditions

COPD Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Bronchial Diseases Bronchiectasis Cardiovascular Diseases Chronic Disease Disease Attributes Gram-Positive Bacterial Infections Heart Diseases Hypertension Hypertension, Pulmonary Idiopathic Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis (IPF) Infections Interstitial Pneumonia Lung Diseases Lung Diseases, Interstitial Lung Diseases, Obstructive Lung Injury Mycobacterium Infections Occupational Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumoconiosis Pulmonary Disease, Chronic Obstructive Pulmonary Fibrosis Pulmonary Heart Disease Pulmonary Hypertension Pulmonary Tuberculosis Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Silicosis Tuberculosis Tuberculosis, Pulmonary Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310000

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >18 years at time of transplantation
  • Received single or bilateral lung transplantation

Exclusion criteria

  • Re-transplantation
  • Multi-organ transplantation
  • Autotransplantation
  • Incomplete medical records: Recipients with >20% missing essential data elements in any of these categories:Preoperative baseline characteristics； Intraoperative parameters；Postoperative outcome measures

Treatment and study plan

Primary outcomes

  1. In-hospital adverse events

    Time frame: Collect data for an expected average about 2 hours

    In-hospital adverse events were defined as post-transplant complications occurring prior to discharge, such as: Grade 3 PGD, respiratory infections, stroke, cardiac events, AKI, or liver impairment.

Secondary outcomes

  1. ICU stay

    Time frame: Collect data for an expected average about 2 hours

    The ICU stay （days） was calculated from the time of ICU admission after surgery completion to actual discharge from the intensive care unit

  2. Postoperative hospital stay

    Time frame: Collect data for an expected average about 2 hours

    Postoperative hospital（days）stay after lung transplantation

  3. In-hospital mortality

    Time frame: Collect data for an expected average about 2 hours

    The proportion of patients who died during the initial hospitalization period following lung transplantation surgery

  4. 30-day postoperative mortality

    Time frame: Collect data for an expected average about 2 hours

    Number of deaths within 30 days post-transplant) / (Total number of lung transplant recipients) × 100%；

  5. 90-day postoperative mortality

    Time frame: Collect data for an expected average about 2 hours

    Number of deaths within 90 days post-transplant) / (Total number of lung transplant recipients) × 100%

  6. The duration of endotracheal intubation

    Time frame: Collect data for an expected average about 2 hours

    Duration of intubation should be recorded from surgery end-time to extubation

Other outcomes

  1. Grade 3 Primary Graft Dysfunction (PGD)

    Time frame: Collect data for an expected average about 2 hours

    PGD3:A ratio of arterial oxygen partial pressure to fraction of inspired oxygen (PaO₂/FiO₂) < 200 mmHg with bilateral infiltrates on chest radiograph, or Requirement for extracorporeal life support (ECLS) within 72 hours postoperatively, or use of inhaled pulmonary vasodilators for >48 hours during mechanical ventilation.

  2. Pulmonary Infection

    Time frame: Collect data for an expected average about 2 hours

    Radiologically confirmed by a staff radiologist as new or progressive pulmonary infiltrates on: Chest X-ray or Computed tomography (CT) scan

  3. Acute Kidney Injury

    Time frame: Collect data for an expected average about 2 hours

    A rise in serum creatinine >120 μmol/L

  4. Cardiovascular Events

    Time frame: Collect data for an expected average about 2 hours

    Acute myocardial infarction； heart failure；Cardiovascular hemorrhage；Clinically significant arrhythmias；Conduction system disorders；Cardiac arrest；Refractory hypotension due to cardiogenic sock.

  5. Hepatic Dysfunction

    Time frame: Collect data for an expected average about 2 hours

    Aspartate aminotransferase (AST) >34 or Alanine aminotransferase (ALT) >40 U/L;

  6. Cerebral Infarction

    Time frame: Collect data for an expected average about 2 hours

    Diagnosed by staff radiologists as new or progressive ischemic lesions on CT or MRI

Study contacts

Contact information is provided by the study sponsor or research team.

Diansan Su, Dr

CONTACT

[email protected]

+8618616514088

chaoqin Chen, Dr

CONTACT

[email protected]

+8613567148312

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2025
Registry last updated
Apr 22, 2025

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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