PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Renal Function

Mechanically Ventilated Patients Clinical Trial

Official title:

A Randomized Study of the PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Renal Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06153498
• Other study ID #: WHUICU202203
• Status: Recruiting
• Phase: Phase 2
• Start date: November 4, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Wuhan Union Hospital, China
• Contact: You Shang, MD
• Phone: +8602785351606
• Email: you_shanghust[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

• 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

• 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

Related Conditions & MeSH terms

• Mechanically Ventilated Patients
• Renal Insufficiency

Intervention

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).

Locations

Country	Name	City	State
China	Wuhan Union Hospital	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China	Yichang Humanwell Pharmaceutical Co., Ltd., China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	peak plasma concentration	Within 24 hours while receiving the study drug
Primary	The area under the plasma drug concentration-time curve	The area under the plasma drug concentration-time curve (AUC)	Within 24 hours while receiving the study drug
Primary	t1/2	half-life	Within 24 hours while receiving the study drug
Secondary	The percentage of time in the target sedation range without rescue sedation	The percentage of time in the target sedation range without rescue sedation	Within 24 hours while receiving the study drug
Secondary	The number and severity of treatment emergent adverse events (TEAEs)	The number and severity of treatment emergent adverse events (TEAEs)	Within 24 hours while receiving the study drug