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

NCT06153498 | Unknown Phase 2

• 1 other identifier: WHUICU202203
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanically Ventilated Patients

Outcome Measures

Primary Outcomes (3)

• Cmax

  peak plasma concentration

  Within 24 hours while receiving the study drug

• 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

• t1/2

  half-life

  Within 24 hours while receiving the study drug

Secondary Outcomes (2)

• The percentage of time in the target sedation range without rescue sedation

  Within 24 hours while receiving the study drug

• The number and severity of treatment emergent adverse events (TEAEs)

  Within 24 hours while receiving the study drug

Study Arms (2)

Normal renal function group

EXPERIMENTAL

Drug: Remimazolam besylate

Renal injury group

EXPERIMENTAL

Drug: Remimazolam besylate

Interventions

Remimazolam besylate DRUG

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).

Normal renal function group; Renal injury group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Yichang Humanwell Pharmaceutical Co., Ltd., China: collaborator

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

Central Study Contacts

You Shang, MD

CONTACT

+8602785351606; you_shanghust@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 1, 2023
• Study Start: November 4, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

CN (1)