Postoperative Complications After Lung TransplantationNCT06603350
The Effect of Perioperative Factors on Postoperative Outcomes After Lung Transplantation
An observational study of Postoperative Complications After Lung Transplantation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
1. Evaluate the influence of perioperative factors on postoperative outcomes in patients undergoing lung transplantation patients. 2. To evaluate the feasibility of using pulmonary ultrasound to identify lung complications such as atelectasis and pulmonary edema after lung transplantation 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications After Lung Transplantation
- What is being tested?
- No intenvention
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2024to Aug 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion Criteria are adult patients undergoing lung transplantation Those undergoing retransplantation,multiple organ transplantation or refusal to participate will be excluded.
Who may be able to join
- Prosedure of lung transplantation, Aged more than 18 years old
Who cannot join
- Secondary lung transplantation, multiple organ transplantation, refusal to participate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 330100
Min Yan, +861375711863, zryanmin@zju.edu.cn
About this study
Official title: The Effect of Perioperative Factors on Postoperative Outcomes in Patients Undergoing Lung Transplantation: a Prospective Observational Study
- Evaluate the influence of perioperative factors on postoperative outcomes in patients undergoing lung transplantation patients.
- To evaluate the feasibility of using pulmonary ultrasound to identify lung complications such as atelectasis and pulmonary edema after lung transplantation
- Observe the changes of perioperative inflammation and immune indexes after lung transplantation
- Being tested
- No intenvention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intenventionOther
No intenvention
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulmonary complications
Incidence of atelectasis and primary graft dysfunction(PGD) detcted by lung ultrasound
Measured: 3 days after surgery
Mortality
Survival rate after lung transplantation
Measured: 1 year after surgery
Secondary outcomes (1)
Inflammatory index IL-6
Variation of perioperative inflammatory index IL-6
Measured: 3 days after after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start28 Jul 2024
- Primary completionFeb 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Complications After Lung TransplantationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603350
- Sponsor's protocol ID
- 2023-0764
- Status last verified
- Jul 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Factors on Postoperative Outcomes in Patients Undergoing Lung Transplantation: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06603350
- Acronym / sponsor ID
- 2023-0764
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 28 Jul 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Evaluate the influence of perioperative factors on postoperative outcomes in patients undergoing lung transplantation patients.
- To evaluate the feasibility of using pulmonary ultrasound to identify lung complications such as atelectasis and pulmonary edema after lung transplantation
- Observe the changes of perioperative inflammation and immune indexes after lung transplantation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria are adult patients undergoing lung transplantation Those undergoing retransplantation,multiple organ transplantation or refusal to participate will be excluded.
Key inclusion criteria (1 listed)
- Prosedure of lung transplantation, Aged more than 18 years old
Key exclusion criteria (1 listed)
- Secondary lung transplantation, multiple organ transplantation, refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intenventionNo intenvention | Other | – |
Primary outcome
Postoperative pulmonary complications
Time frame: 3 days after surgery
Incidence of atelectasis and primary graft dysfunction(PGD) detcted by lung ultrasound
Mortality
Time frame: 1 year after surgery
Survival rate after lung transplantation
1 secondary outcome
Inflammatory index IL-6
Time frame: 3 days after after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Postoperative Complications After Lung Transplantation
RecruitingObservational study
Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation
Primary Graft Dysfunction, Lung Transplantation
Active, not recruitingObservational study
Identifying Genetic Characteristics That Increase Risk of Primary Graft Dysfunction Following Lung Transplantation
Primary Graft Dysfunction, Lung Transplantation
RecruitingObservational study
Association Between Renal Regional Oxygen Saturation Measured by Near-InfraRed Spectroscopy and Postoperative Renal Failure After Lung Transplantation Surgery: A Pilot Study
Lung Transplant; Complications, Acute Kidney Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Anesthesiology, Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications After Lung Transplantation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pulmonary complications (time frame: 3 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.