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Tests treatment safety and results for Respiratory Insufficiency
Official title The Evaluation of the Effectiveness and Safety of Nalbuphine Hydrochloride Injection for Analgesia in ICU Patients: A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial
ClinicalTrials.gov ID: NCT06785571
What this study is testing
What is Nalbuphine hydrochloride injection?
Nalbuphine hydrochloride injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for respiratory insufficiency.
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
- The analgesic effect of nalbuphine hydrochloride injection will be evaluated in a multicenter, randomized, single-blind, parallel, positive-controlled approach in two steps: step 1, to explore the optimal dosage of nalbuphine hydrochloride injection with 2 experimental arms and 1 positive control and step 2, to evaluate the effectiveness and safety of nalbuphine hydrochloride injection in mechanically ventilated ICU patients at a dosage determined in step 1 with the same positive control.
- Phase 3: a large, late-stage study
- 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 to 80
You may be able to join if
- ICU patients who are intubated are expected to require mechanical ventilation for more than 6h
- patients or their guardians have a full understanding of the purpose and significance of this trial, and voluntarily participate in this clinical...
You likely can't join if
- Allergy or unsuitability to any composition of study drugs or propofol
- Living expectancy of less than 48 hours
- Neurological disorder and any other condition interfering with sedation assessment
- Gastrointestinal obstruction
- Asthmatic
- Abdominal compartment syndrome
See the full eligibility criteria
- ICU patients who are intubated are expected to require mechanical ventilation for more than 6h
- patients or their guardians have a full understanding of the purpose and significance of this trial, and voluntarily participate in this clinical trial and sign an informed consent form
- Allergy or unsuitability to any composition of study drugs or propofol
- Living expectancy of less than 48 hours
- Neurological disorder and any other condition interfering with sedation assessment
- Gastrointestinal obstruction
- Asthmatic
- Abdominal compartment syndrome
- Serious hepatic dysfunction (CTP 10-15)
- Acute kidney injury (KDIGO stage 2 or 3) or Chronic kidney disease with glomerular filtration rate (GFR) \< 29 ml/min/1.73m2
- Circulatory instability (the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain proper blood pressure)
- Need deep sedation or paralytics
- Anticipation to receive operations (including tracheotomy)
- Abuse of controlled substances or alcohol
- Pregnancy, lactation, or an intention of gestation in 6 months
- Inclusion in another treatment trial in the past 30 days
- Other conditions deemed unsuitable to be included
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, 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.