Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-25 @ 2:39 PM
Study NCT ID:
NCT06603350
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Perioperative Factors on Postoperative Outcomes After Lung Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Peripheral blood serum at 5 timepoints，before ansethesia induction, at the end of surgery, 24h after surgery, 48h after surgery and 72h after surgery'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2024-09-05', 'studyFirstSubmitQcDate': '2024-09-17', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pulmonary complications', 'timeFrame': '3 days after surgery', 'description': 'Incidence of atelectasis and primary graft dysfunction(PGD) detcted by lung ultrasound'}, {'measure': 'Mortality', 'timeFrame': '1 year after surgery', 'description': 'Survival rate after lung transplantation'}], 'secondaryOutcomes': [{'measure': 'Inflammatory index IL-6', 'timeFrame': '3 days after after surgery', 'description': 'Variation of perioperative inflammatory index IL-6'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Complications After Lung Transplantation']}, 'descriptionModule': {'briefSummary': '1. Evaluate the influence of perioperative factors on postoperative outcomes in patients undergoing lung transplantation patients.\n2. To evaluate the feasibility of using pulmonary ultrasound to identify lung complications such as atelectasis and pulmonary edema after lung transplantation\n3. Observe the changes of perioperative inflammation and immune indexes after lung transplantation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion Criteria are adult patients undergoing lung transplantation Those undergoing retransplantation,multiple organ transplantation or refusal to participate will be excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nProsedure of lung transplantation, Aged more than 18 years old\n\nExclusion Criteria:\n\nSecondary lung transplantation, multiple organ transplantation, refusal to participate'}, 'identificationModule': {'nctId': 'NCT06603350', 'briefTitle': 'The Effect of Perioperative Factors on Postoperative Outcomes After Lung Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'The Effect of Perioperative Factors on Postoperative Outcomes in Patients Undergoing Lung Transplantation: a Prospective Observational Study', 'orgStudyIdInfo': {'id': '2023-0764'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intenvention', 'type': 'OTHER', 'description': 'No intenvention'}]}, 'contactsLocationsModule': {'locations': [{'zip': '330100', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Yan', 'role': 'CONTACT', 'email': 'zryanmin@zju.edu.cn', 'phone': '+861375711863'}], 'facility': 'Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}