Trial · NCT07885540
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of participants with postoperative pulmonary infection within 30 days after surgery | From surgery to 30 days after surgery | Pulmonary infection defined by modified US CDC/NHSN criteria (new or progressive pulmonary infiltrate on imaging, at least 1 clinical sign and at least 2 respiratory signs), confirmed by an independent Endpoint Adjudication Committee blinded to group assignment. |
| Secondary | Proportion of participants with postoperative pulmonary infection within 90 days after surgery | From surgery to 90 days after surgery | Same definition and blinded adjudication as the primary outcome. |
| Secondary | Proportion of participants with postoperative pulmonary infection within 180 days after surgery | From surgery to 180 days after surgery | Same definition and blinded adjudication as the primary outcome. |
| Secondary | Incidence of severe pneumonia | Within 30, 90 and 180 days after surgery | Severe pneumonia defined as 1 major criterion (invasive mechanical ventilation; septic shock requiring vasopressors) or at least 3 minor criteria (respiratory rate 30/min or more; PaO2/FiO2 250 or less; multilobar infiltrates; confusion/disorientation; BUN 20 mg/dL or more; WBC below 4000/mm3 due to infection; platelets below 100,000/mm3; core temperature below 36 degrees C; hypotension requiring aggressive fluid resuscitation). |
| Secondary | Incidence of respiratory failure | Within 30, 90 and 180 days after surgery | Type I: PaO2 below 60 mmHg with normal or low PaCO2 (50 mmHg or less). Type II: PaO2 below 60 mmHg with PaCO2 above 50 mmHg. |
| Secondary | Incidence of Streptococcus pneumoniae infection | Within 30, 90 and 180 days after surgery | Any of: S. pneumoniae isolated from sputum, bronchoalveolar lavage fluid or blood culture; positive urinary pneumococcal antigen; or a 4-fold or greater rise in serum pneumococcal antibody titer between acute and convalescent samples. |
| Secondary | Incidence of influenza virus infection | Within 30, 90 and 180 days after surgery | Any of: positive influenza RT-PCR on nasopharyngeal swab, sputum or bronchoalveolar lavage fluid; positive rapid antigen test; positive viral culture; or positive influenza-specific IgM or a 4-fold or greater rise in IgG titer. |
| Secondary | Postoperative length of hospital stay | From end of surgery to hospital discharge, assessed up to 180 days | Number of days from leaving the operating room to hospital discharge. |
| Secondary | Rate of postoperative ICU admission | From surgery to hospital discharge, assessed up to 180 days | |
| Secondary | Length of ICU stay | From surgery to hospital discharge, assessed up to 180 days | Duration of ICU stay in hours. |
| Secondary | Rate of unplanned postoperative antibiotic use | From surgery to 180 days after surgery | Proportion of participants in whom antibiotics are restarted for suspected infection after discontinuation of postoperative prophylactic antibiotics. |
| Secondary | Duration of postoperative chest tube drainage | From surgery to chest tube removal, assessed up to 180 days | Number of days the chest tube remains in place after surgery. |
| Secondary | 30-day unplanned readmission rate | Within 30 days after surgery | Readmission due to fever, dyspnea or thoracic infection. |
| Secondary | Total hospitalization costs | From admission for surgery to 180 days after surgery | Total costs including drug, examination, surgical and material costs. |
| Secondary | Antibiotic costs | From admission for surgery to 180 days after surgery | |
| Secondary | Incidence of adverse events and serious adverse events | From randomization to 180 days after surgery | Including local and systemic vaccine reactions; graded according to NCI-CTCAE version 5.0. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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