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New treatment option for Acute Respiratory Distress Syndrome
Official title Nalbuphine in ARDS Patients After Surgery
ClinicalTrials.gov ID: NCT06037330
What this study is testing
What is Nalbuphine?
Nalbuphine is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute respiratory distress syndrome.
Also referred to as Nalbuphine Hydrochloride Injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Critically ill patients need reasonable and moderate analgesic and sedative treatment to eliminate or reduce pain, anxiety and restlessness, improve patient comfort and cooperation, reduce patients' stress response, protect organ function and optimize prognosis. As a semi-synthetic opioid receptor agonist-antagonist, nalbuphine can bind to μ, κand δ receptors, has partial antagonistic effect on μ receptor, and is fully activated on κreceptor, with very weak δ receptor activity.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Had undergone surgical treatment within 7 days before enrollment;
- Meet the diagnostic criteria for ARDS proposed at the 2011 Berlin ARDS Definition Conference;
- Age ≥18 years old, gender unlimited;
- Patients admitted to ICU with CPOT score ≥3;
- Stay in ICU ≥48h;
You likely can't join if
- APACHE II score ≥23 points;
- Patients with esophageal reflux disease and severe gastrointestinal injury have AGI score ≥3;
- Long-term use of narcotic analgesics, hypnotics and psychotropic drugs;
- Alcohol withdrawal symptoms;
- Severe liver dysfunction (Child-Pugh grade C);
- Patients with bronchial asthma and myasthenia gravis;
See the full eligibility criteria
- Had undergone surgical treatment within 7 days before enrollment;
- Meet the diagnostic criteria for ARDS proposed at the 2011 Berlin ARDS Definition Conference;
- Age ≥18 years old, gender unlimited;
- Patients admitted to ICU with CPOT score ≥3;
- Stay in ICU ≥48h;
- Sign the informed consent form.
- APACHE II score ≥23 points;
- Patients with esophageal reflux disease and severe gastrointestinal injury have AGI score ≥3;
- Long-term use of narcotic analgesics, hypnotics and psychotropic drugs;
- Alcohol withdrawal symptoms;
- Severe liver dysfunction (Child-Pugh grade C);
- Patients with bronchial asthma and myasthenia gravis;
- Patients with severe craniocerebral injury, brain tumor, and increased intracranial pressure are prone to respiratory depression;
- Patients undergoing cardiac surgery under cardiopulmonary bypass;
- Patients who have been enrolled in other clinical trials;
- Study patients with drug allergy or other contraindications;
- Pregnant or lactating women;
- The patient himself or his legally authorized representative is unwilling to sign the informed consent;
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.