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A single-center, historical-controlled study of the effect of Xpert Carba-R carbapenem-resistant bacteria detection in donor on the efficacy of adult lung transplantation

A single-center, history-controlled study of the effect of Xpert Carba-R carbapenem-resistant bacteria detection in donor on the efficacy of adult lung transplantation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053687
Enrollment
Unknown
Registered
2021-11-27
Start date
2021-11-25
Completion date
Unknown
Last updated
2023-07-16

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

Conditions

Donor-derived infection in lung transplantation

Interventions

Donor CARBA-R detection group:GeneXpert and CARBA-R kit were used to detect the donor before lung transplantation
Control lung transplantation group:GeneXpert combined with Carba-R kit was not used to detect CRO infection in donor lungs and received lung transplantation

Sponsors

Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for donor lungs (all criteria are met): the same as the recipient's ABO blood type, or different but compatible; donor aged 18 to 70 years old; oxygenation index (P/F) > 250 mmHg (FiO2= 1.0, PEEP=5cmH2O); chest X-ray lung field is clear or there is a small to moderate amount of exudation; organ donor and recipient are well matched or poorly matched, but donor lung volume reduction or lobe transplantation can be performed according to specific conditions ; The donor has no chest trauma or there is chest trauma but the lung oxygenation is satisfactory; the donor has no or slight aspiration; no purulent secretions in the airway or the presence of purulent secretions improves after treatment and maintenance; the donor lung Cold ischemia time < 12 hours; 2. Inclusion criteria for recipients: age of recipients <=75 years old; normal or mildly abnormal liver and kidney functions.

Exclusion criteria

Exclusion criteria: 1. Donor lung exclusion criteria (meeting one of the criteria): Legal documents such as organ donation confirmation cannot be obtained; microbial culture confirms that the donor has pan-drug-resistant or pan-drug-resistant bacterial infection; 2. Receptor exclusion criteria: immunosuppressed state; severe dysglycemia.

Design outcomes

Primary

MeasureTime frame
CRO-related DDI incidence;

Secondary

MeasureTime frame
Incidence of infection-related serious complications;Mortality of infection-related severe complications;Intensity of antibiotic use;length of hospital stay;Health economic indicators;

Countries

China

Contacts

Public ContactZhou Wenyong

Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University

dr.zhouwenyong@foxmail.com+86 15821673400

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026