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Observation on the Therapeutic Effect of Sivelestat Sodium in the Treatment of Severe Neurological Patients with Aspiration Pneumonia

Observation on the Therapeutic Effect of Sivelestat Sodium in the Treatment of Severe Neurological Patients with Aspiration Pneumonia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122828
Enrollment
Unknown
Registered
2026-04-19
Start date
2023-06-02
Completion date
Unknown
Last updated
2026-04-20

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

Conditions

Severe Neurological Patients with Aspiration Pneumonia

Interventions

Control Group:Patients were subjected to conventional neurocritical care, including anti-infection therapy, correction of fluid-electrolyte and acid-base imbalances, dehydration and intracranial press
Experiment group:In addition to the control group’s treatment, patients received Sivelestat sodium therapy.

Sponsors

The Second Affiliated Hospital of Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meeting the diagnostic criteria for neurocritical illness: patients with underlying conditions such as stroke or traumatic brain injury, who developed life-threatening conditions including impaired consciousness, quadriplegia, respiratory muscle paralysis, or respiratory failure after disease onset were classified as neurocritical cases; 2. Meeting the diagnostic criteria for aspiration pneumonia: presence of risk factors such as impaired consciousness, dysphagia, or poor oral hygiene, combined with clinical evidence of aspiration (e.g., sudden dyspnea, irritative cough) and imaging findings showing gravity-dependent pulmonary infiltrates; 3. Signed informed consent obtained from the patient's family or legal representative; 4. Complete clinical data without missing information.

Exclusion criteria

Exclusion criteria: 1. History of previous allergy to the study drug; 2. Pregnant or lactating women; 3. Refusal of family members to cooperate; 4. Coexisting chronic obstructive pulmonary disease (COPD), interstitial lung disease, or other pulmonary diseases; 5. Presence of confirmed extrapulmonary infection leading to pulmonary infection; 6. Patients with hematological or immune system disorders; 7. Patients with hepatic or renal insufficiency; 8. Patients with active bleeding or coagulation dysfunction; 9. Patients with malignant tumors; 10. Long-term use of systemic immunosuppressants or chemotherapeutic agents; 11. History of arrhythmia; 12. History of aspiration pneumonia.

Design outcomes

Primary

MeasureTime frame
partial pressure of oxygen;

Secondary

MeasureTime frame
partial pressure of carbon dioxide;heart rate;mean arterial pressure;Interleukin-6;C-reactive protein;Procalcitonin;acute physiology and chronic health evaluation;clinical pulmonary infection score;the durations of mechanical ventilation;length of ICU stay;incidence of adverse reactions;28-day mortality rate;

Countries

China

Contacts

Public ContactWang Lei

The Second Affiliated Hospital of Shandong First Medical University

wanglei1818@163.com+86 185 5387 9258

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026