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The efficacy of sivillistat sodium in acute lung injury after abdominal surgery: one single-center, prospective, randomized, controlled trial

The efficacy of sivillistat sodium in acute lung injury after abdominal surgery: one single-center, prospective, randomized, controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058400
Enrollment
Unknown
Registered
2022-04-08
Start date
2022-04-30
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

acute lung injury

Interventions

The control group:Normal saline 50ml micropump was administered intravenously at constant speed for 24 hours, and the course of treatment was 3 days.
the study group:Basic treatment + Sivillistat sodium Standard medication regimen: 4.8mg/kg/ day, after dissolving with normal saline, add daily amount of Sivillistat sodium to 48mL normal saline and g

Sponsors

the Sixth Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who agree to participate in the study and sign the informed consent form; 2. Adult male or female, aged from 18 to 80; 3. Patients within 10 days (including 10 days) after abdominal surgery; 4. Patients with acute lung injury after abdominal surgery accompanied by SIRS. SIRS diagnostic criteria: meet at least 2 of the following 4 items: 1. Body temperature > 38 ? or 90 times/minute; 3. Respiration > 20 times/minute or arterial partial pressure of carbon dioxide (PaCO2) 12 × 10 ^ 9/L or 10%. Diagnostic criteria for acute lung injury: 1. Within 1 week after the known clinical onset or respiratory symptoms are new or aggravated; 2. Thoracic imaging changes: X-ray or CT scanning showed that the transparency of both lungs was reduced, and pleural effusion, pulmonary lobe/lung collapse or nodules could not be fully explained; 3. Causes of pulmonary edema: respiratory failure that cannot be fully explained by heart failure or body fluid overload. If there are no risk factors, objective evaluation (such as echocardiography) is required to exclude hydrostatic edema; 4. Hypoxemia: PaO2/FiO2 = 300mmHg.

Exclusion criteria

Exclusion criteria: 1. ALI/ARDS existed before operation; 2. Patients with 4 or more multiple organ injuries including lungs; 3. According to the score of multiple organ failure (SOFA) (see Table 1), one of the following two items is met: 1) Oxygenation index<100 mmHg 2) The scores of other 2 organ systems other than lung exceed 2 points respectively (excluding 2 points) 4. Congestive heart failure, diffuse pulmonary infection, severe systemic infection and other diseases affecting the diagnosis; 5. People with allergic constitution; 6. Pregnant women, lactating women and women who may be pregnant; 7. Severe primary diseases affecting survival, such as tumor, blood disease, uncontrolled diabetes patients; 8. Patients with neurosis; 9. Patients who cannot effectively treat the primary disease; 10. Patients that doctors think are not suitable for this trial.

Design outcomes

Primary

MeasureTime frame
PaO2/FiO2;

Secondary

MeasureTime frame
Murray score;A-aDO2;Mechanical ventilation time;Length of stay in ICU;Bronchoalveolar lavage fluid (BALF)IL-1;Bronchoalveolar lavage fluid (BALF)IL-8;Bronchoalveolar lavage fluid (BALF)IL-10;Bronchoalveolar lavage fluid (BALF)IL-6;IL - 1 in the plasma;IL - 6 in the plasma;IL - 8 in the plasma;IL - 10 in the plasma;C-reactive protein;a neutrophil count in BALF;neutrophil elastase in BALF;28 day in-hospital mortality;

Countries

china

Contacts

Public Contactchen lei

the Sixth Affiliated Hospital of Sun Yat-Sen University

chenlei6@mail.sysu.edu.cn+86 13570236595

Outcome results

None listed

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