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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Wuhan Union Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: You Shang, MD
• Email: you_shanghust@163.com
• Phone: +8602785351606

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.