Evaluating the safety and effects of Remazolam Besylate in ICU patients with kidney issues

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

This study is testing how safe and effective a new medication called Remazolam Besylate is for ICU patients on ventilators, especially those with kidney problems.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Wuhan Union Hospital, China (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT06153498 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the pharmacokinetic and pharmacodynamic properties of Remazolam Besylate in ICU patients who are mechanically ventilated and have either impaired or normal renal function. The study aims to compare the drug's effects and safety by monitoring hemodynamic parameters and recording any adverse events. Patients will be assessed based on their renal function, with specific criteria for inclusion and exclusion to ensure safety and relevance of results.

Who should consider this trial

Good fit: Ideal candidates are intubated and mechanically ventilated patients with a BMI between 18 and 30 kg/m2 and a glomerular filtration rate indicating either impaired or normal renal function.

Not a fit: Patients with severe renal impairment (GFR < 29 ml/min/1.73m2) or those with certain serious conditions like myasthenia gravis or status asthmaticus may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve sedation management in ICU patients with renal impairment, enhancing patient safety and comfort.

How similar studies have performed: While this approach is focused on a specific patient population, similar studies evaluating sedation in ICU settings have shown promising results, indicating potential for success.

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

Where this trial is running

Wuhan, Hubei

• Wuhan Union Hospital — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: You Shang, MD

Conditions Mechanically Ventilated Patients