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Inhaled Nitric Oxide for the Prevention of Primary Graft Dysfunction After Lung Transplantation

Inhaled Nitric Oxide for the Prevention of Primary Graft Dysfunction After Lung Transplantation: A Multicenter Randomized Single-Blind Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078778
Enrollment
Unknown
Registered
2023-12-18
Start date
2023-12-18
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Transplantation

Interventions

iNO treatment group:Group A (Treatment Group): Patients will begin inhaling iNO at 10 ppm immediately after surgery in the ICU, continuing for 40 hours, followed by a gradual reduction in concentratio
Control Group):Group B (Control Group): Patients will receive standard ventilation protocols without inhaling iNO.

Sponsors

The Second Affiliated Hospital Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age =18 years Patients scheduled for lung transplantation Able to understand the purpose of the study and potential risks, and willing to sign an informed consent form.

Exclusion criteria

Exclusion criteria: Combined organ transplantation Non-first-time lung transplantation Preoperative ECMO bridging for lung transplantation Donor was a cardiac death Pregnancy Known allergy to prostaglandins (extremely rare) Need for or planned use of NO donor drugs (nitroglycerin, sodium nitroprusside, nicorandil, FK409, SIN-1, isosorbide mononitrate, and isosorbide dinitrate) Participant involvement in another conflicting clinical study protocol

Design outcomes

Primary

MeasureTime frame
Incidence rate of PGD-2/3;

Secondary

MeasureTime frame
Incidence rate of PGD-2/3;Changes in pulmonary artery pressure;Inflammatory levels in bronchoalveolar lavage fluid;Duration of mechanical ventilation post-surgery;Duration of ECMO use;Duration of ICU stay and total hospitalization time;Incidence rate of acute kidney injury;mortality rates;

Countries

China

Contacts

Public ContactMan Huang

The Second Affiliated Hospital Zhejiang University School of Medicine

huangman@zju.edu.cn+86 139 0651 8699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026