PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Renal Function
Study Details
Study Description
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 and adverse events.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Normal renal function group
|
Drug: Remimazolam besylate
After a loading dose of 0.05mg/kg, a maintaining dose of 0.2mg/kg/h is given; It is recommended to adjust the infusion rate of Remazolam besylate for injection at a amplitude of 0.05mg/kg/h, mainly based on the RASS score of the subjects (the adjustment range is 0-1.0 mg/kg/h, and the maximum infusion rate is not more than 1.0mg/kg/h) until the subjects reach the optimal sedation level (-3≤RASS≤0).
|
| Experimental: Renal injury group
|
Drug: Remimazolam besylate
After a loading dose of 0.05mg/kg, a maintaining dose of 0.2mg/kg/h is given; It is recommended to adjust the infusion rate of Remazolam besylate for injection at a amplitude of 0.05mg/kg/h, mainly based on the RASS score of the subjects (the adjustment range is 0-1.0 mg/kg/h, and the maximum infusion rate is not more than 1.0mg/kg/h) until the subjects reach the optimal sedation level (-3≤RASS≤0).
|
Outcome Measures
Primary Outcome Measures
- Cmax [Within 24 hours while receiving the study drug]
peak plasma concentration
- The area under the plasma drug concentration-time curve [Within 24 hours while receiving the study drug]
The area under the plasma drug concentration-time curve (AUC)
- t1/2 [Within 24 hours while receiving the study drug]
half-life
Secondary Outcome Measures
- The percentage of time in the target sedation range without rescue sedation [Within 24 hours while receiving the study drug]
The percentage of time in the target sedation range without rescue sedation
- The number and severity of treatment emergent adverse events (TEAEs) [Within 24 hours while receiving the study drug]
The number and severity of treatment emergent adverse events (TEAEs)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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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 Criteria:
-
Refusal to be included
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Allergy or unsuitability to any composition of study drugs or remifentanil
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Living expectancy less than 48 hours
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Myasthenia gravis
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Status asthmaticus
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Abdominal compartment syndrome
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Serious hepatic dysfunction (CTP 10-15);
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Chronic kidney disease with glomerular filtration rate (GFR) < 29 ml/ min/1.73m2
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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
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Possible requirement for surgery or bedside tracheostomy in 24 hours
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Possible requirement for renal replacement therapy in 24 hours
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Acute severe neurological disorder and any other condition interfering with sedation assessment
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Abuse of controlled substances or alcohol
-
Pregnancy or lactation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wuhan Union Hospital | Wuhan | Hubei | China | 430022 |
Sponsors and Collaborators
- Wuhan Union Hospital, China
- Yichang Humanwell Pharmaceutical Co., Ltd., China
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WHUICU202203