Clinical trial

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

Name

WHUICU202203

Description

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.

Trial arms

Trial start

2023-11-04

Estimated PCD

2024-12-01

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

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).

Arms:

Normal renal function group, Renal injury group

Size

Primary endpoint

Cmax

Within 24 hours while receiving the study drug

The area under the plasma drug concentration-time curve

Within 24 hours while receiving the study drug

t1/2

Within 24 hours while receiving the study drug

Eligibility 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 * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}

Updated at

2023-12-13

1 organization

1 product

1 indication

Organization

Wuhan Union Hospital

Product

Remimazolam

Indication

mechanical ventilation