Mechanical ventilation
Conditions
Interventions
Sivelestat sodium hydrate (SSH) group:Sivelestat sodium hydrate (SSH) was administered with a constant infusion of 0.2mg/kg/h in combination with a minimum dose of remifentanil for analgesia lasting f
Placebo group:Placebo was administered with a constant infusion of 0.2mg/kg/h in combination with a minimum dose of remifentanil for analgesia lasting for 96h after randomization
Sponsors
Huai'an first People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1: 18-70 years old 2: Invasive mechanical ventilation =24 h and no extubation was expected within 48h after randomization 3: No surgery has been performed in the past week 4: Obtain and sign the informed consent
Exclusion criteria
Exclusion criteria: 1: Pregnant or lactating women; 2: Uncoordinated assessment of analgesia and sedation; 3: There are contraindications to use of sivelestat sodium hydrate, remifentanil, propofol, or cyclamate; 4: Need for deep sedation (RASS score = -4. and/or need for neuromuscular blockade); 5: There were suspicious or definite primary brain injuries (traumatic brain injury, cerebral infarction, intracranial hemorrhage, spinal cord injury, hypoxic-ischemic encephalopathy, hydrocephalus and brain edema); 6: Decompensated heart failure (EF < 30%) , Cardiogenic shock and acute myocardial infarction; 7: Creatinine clearance rate < 30 ml/min; 8: End-stage liver disease (Child-pugh C); 9: Patients with malignant disease who are receiving radiotherapy or chemotherapy; 10: Surgery or tracheotomy is expected within 48 hours; 11: Drug and/or alcohol abuse; 12: Palliative care or expected death within 48 hours; 13: History of dementia or mental illness, and the need for psychotropic medications; 14: Participating in clinical trials of other drugs or has participated in other clinical trials within 30 days 15: The use of opioids for analgesia is not considered necessary by clinicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average remifentanil consumption (ug) per kilogram of body weigh during 96h of randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day mortality;mechanical ventilation free days within 28 days of randomization;vasoactive agent free days within 28 days of randomization;renal replacement therapy free days within 28 days of randomization; | — |
Countries
China
Contacts
Public ContactZhang Xiang Cheng
Huai'an first People's Hospital
Outcome results
None listed