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Efficacy and safety evaluation of Ulinastatin for injection on pulmonary function protection in adult cardiac surgery with cardiopulmonary bypass: a prospective, randomized, blank control clinical study

Efficacy and safety evaluation of Ulinastatin for injection on pulmonary function protection in adult cardiac surgery with cardiopulmonary bypass: a prospective, randomized, blank control clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052282
Enrollment
Unknown
Registered
2021-10-24
Start date
2021-11-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

cardiac surgery under cardiopulmonary bypass

Interventions

Experimental group:Ulinastatin for injection on the basis of conventional treatment
Control group:Conventional treatment

Sponsors

Xijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients or their immediate family members signed a written informed consent; 2. Aged 18 to 65 years, no gender limit; 3. Cardiac surgery under cardiopulmonary bypass; 4. Elective surgery.

Exclusion criteria

Exclusion criteria: 1. The clinician believes that it is not suitable for clinical research; 2. Emergency surgery; 3. Patients participating in other clinical studies; 4. Pregnant patients; 5. Patients with infectious diseases; 6. Patients with severe anemia (hemoglobin content <10g/dL).

Design outcomes

Primary

MeasureTime frame
PaO2/FiO2 at 8 hours after surgery;

Secondary

MeasureTime frame
PaO2/FiO2 ratio and the frequency and ratio of the ratio >= 300 every 4 hours within 72 hours after surgery;Postoperative mechanical ventilation time;Incidence of secondary mechanical ventilation;Incidence of postoperative use of ECMO assistance for respiratory failure;Proportion of postoperative pulmonary infection;Cardiac function-related parameters;Associated inflammatory factors;Renal function-related indexes;Perioperative costs;Safety evaluation indicators;

Countries

China

Contacts

Public ContactJin Zhenxiao

Xijing Hospital

1045151706@qq.com+86 13571921011

Outcome results

None listed

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