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A prospective cohort study of sivelestat sodium for acute lung injury after cardiac surgery under cardiopulmonary bypass

A prospective cohort study of sivelestat sodium for acute lung injury after cardiac surgery under cardiopulmonary bypass

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200059102
Enrollment
Unknown
Registered
2022-04-25
Start date
2022-04-01
Completion date
Unknown
Last updated
2024-02-11

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

Conditions

cardiovascular diseases

Interventions

Group of patients who received sivelestat sodium:None
Group of patients who did not receive sivelestat sodium:None

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Receive heart surgery under extracorporeal circulation; 2. Acute lung injury occurred after surgery (PaO2/FiO2<300 mmHg); 3, No gender limit, aged 18-80 years; 4. Sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Preoperative hepatic and renal insufficiency (EGFR < 35ml/min/1.73m^2; Child Pugh B or C); 2. Severe hypocardiac syndrome or multiple organ dysfunction after surgery; 3. Estimated survival time <72h; 4. Respiratory failure caused by heart failure or fluid overload; 5. Central respiratory failure or severe mechanical lung injury caused by stroke after surgery; 6. Preoperative complications of pulmonary diseases, such as clearly diagnosed pneumonia, tuberculosis, pleurisy and restricted ventilation dysfunction (FEV1 < 70%pred or clinically diagnosed obvious airway obstructive disease, bronchiectasis or pulmonary interstitial fibrosis with an area of more than 20% lung volume); 7. Pregnant or lactating patients or patients who may be pregnant; 8. History of malignant tumor, autoimmune disease or infectious disease; 9. Died during surgery.

Design outcomes

Primary

MeasureTime frame
Perioperative respiratory adverse events;

Secondary

MeasureTime frame
Mortality;Total length of stay;Length of ICU stay;Mechanical ventilation duration;

Countries

China

Contacts

Public ContactWang Dongjin
wangdongjin@njglyy.com+86 13915980346

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026