Status:
UNKNOWN
PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Renal Function
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
Yichang Humanwell Pharmaceutical Co., Ltd., China
Conditions:
Mechanically Ventilated Patients
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Pharmacokinetic/pharmacodynamic profiles of remazolam besylate were compared in patients with impaired and normal renal function in the ICU, and safety was assessed by recording hemodynamic parameters...
Eligibility Criteria
Inclusion
- Body mass index (BMI) ≥18 and ≤ 30 kg/m2
- Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on a ventilator for at least 6 hours
- Requirement for light to moderate sedation (a Richmond agitation-sedation scale score of -2 to 1) Patients with impaired renal function were defined as having a glomerular filtration rate of 30 to 89 ml/min/1.73m2. Patients with normal renal function were defined as having a glomerular filtration rate of 90 to 120 ml/min/1.73m2
Exclusion
- Refusal to be included
- Allergy or unsuitability to any composition of study drugs or remifentanil
- Living expectancy less than 48 hours
- Myasthenia gravis
- Status asthmaticus
- Abdominal compartment syndrome
- Serious hepatic dysfunction (CTP 10-15);
- Chronic kidney disease with glomerular filtration rate (GFR) \< 29 ml/ min/1.73m2
- Mean blood pressure less than 65 mm Hg or the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain Mean blood pressure ≥ 65 mm Hg
- Possible requirement for surgery or bedside tracheostomy in 24 hours
- Possible requirement for renal replacement therapy in 24 hours
- Acute severe neurological disorder and any other condition interfering with sedation assessment
- Abuse of controlled substances or alcohol
- Pregnancy or lactation
Key Trial Info
Start Date :
November 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06153498
Start Date
November 4 2023
End Date
December 1 2024
Last Update
December 13 2023
Active Locations (1)
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1
Wuhan Union Hospital
Wuhan, Hubei, China, 430022