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Effect of oxycodone hydrochloride injection in patients diagnosed with sepsis induced acute lung injury

Effect of oxycodone hydrochloride injection in patients diagnosed with sepsis induced acute lung injury

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080454
Enrollment
Unknown
Registered
2024-01-30
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

septic acute lung injury

Interventions

Oxycodone hydrochloride group:Intravenous infusion of oxycodone hydrochloride injection 5 minutes prior to endotracheal intubation for mechanical ventilation
Sufentanil Injection group:Equivalent doses of sufentanil injection (1:0.001) were administered intravenously using a venous pump

Sponsors

Tianjin Nankai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age =18 years old, gender and ethnicity are not limited; (2) All patients diagnosed to meet with the Sepsis 3.0 criteria and the International Consensus Guidelines for Septic Shock: Diagnostic criteria for septic acute lung injury included the corresponding history of primary disease; clinical symptoms of breathing difficulty or distress; Hypoxemia, is classified as follows based on the PaO2/FiO2 ratio under positive end-expiratory pressure (PEEP) of at least 5cmH2O: 200mmHg <PaO2/FiO2=300mmHg(Mild) ; 100mmHg< PaO2/FiO2= 200mmHg(Moderate) ; PaO2/FiO2= 100mmHg(Severe) ; chest radiographs showed bilateral pulmonary infiltration; insertion of an endotracheal catheter for positive-pressure ventilation was required; and there was no clinical evidence of left atrial hypertension to account for the bilateral pulmonary infiltration(or pulmonary wedge pressure= 18 mmHg). 3) Agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Refuse to participate in this study; 2) People with opioid allergy; 3) A history of narcotic analgesic drugs abuse; 4) Pregnant and lactating women; 5) Concurrent use of monoamine oxidase inhibitors or within 2 weeks after discontinuation; 6) Moderate to severe liver function impairment; 7) Severe renal function impairment with creatinine clearance <10 ml/min; 8) Currently being included in another study; 9) The attending physician or investigators consider that there are other inappropriate circumstances for participating in this study (reasons should be recorded).

Design outcomes

Primary

MeasureTime frame
Monitor blood gas analysis before and after drug administration, and calculate oxygenation index (PaO2/FiO2), respiratory index and PA-aO2;Record the change of lung injury scores after intubation;

Secondary

MeasureTime frame
Record APACHE-II scores, Murray scores and SOFA scores;Record the duration of mechanical ventilation, extubation time, and PEEP pressure changes.;Record the number of ICU days, total hospital days, postoperative complications, ICU mortality, and hospital mortality;Detect the changes in WBC, CRP, PCT, Lac, and PH before and after drug administration;Determine the changes of HO-1 activity and CC-16 activity in the serum of patients before and after drug administration;Record the number of patients with organ failure, and adverse events;

Countries

China

Contacts

Public ContactYu Jianbo

Tianjin Nankai Hospital

30717008@nankai.edu.cn+86 186 9808 7176

Outcome results

None listed

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