Mechanically Ventilated PatientsNCT06153498
PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Renal Function
A study testing Remimazolam besylate in people with Mechanically Ventilated Patients, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mechanically Ventilated Patients
- What is being tested?
- Remimazolam besylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2023to 13 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤80 years, regardless of gender;
- Anticipated requirement for mechanical ventilation and sedation ≥24 hours;
- arget sedation level within RASS score range of -3 to 0 (inclusive);
- Patients with renal impairment were defined as having a glomerular filtration rate (GFR) <90 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
Who cannot join
- BMI<18 or >30kg/m2;
- Hypersensitivity to study drugs/opioids/reversal agents;
- Life expectancy <48 hours;
- Scheduled surgery requiring general anesthesia within 24h;
- Myasthenia gravis;
- Moderate-severe hepatic impairment (Child-Pugh ≥B);
Show all 13Show fewer
- Severe CKD (eGFR <30 mL/min/1.73m²) or renal replacement therapy within 3 days;
- Recent benzodiazepine use (≤1 week) or chronic benzodiazepine dependence;
- Hemodynamic instability (≥2 vasopressors to maintain SBP >90 mmHg);
- Inability to perform RASS assessment (e.g., major neuropsychiatric disorders, coma);
- Pregnancy/lactation;
- Acute coronary syndrome or severe cardiac dysfunction (LVEF ≤30%, advanced heart block, HR<50 bpm without pacing);
- Active ECMO/IABP support; Substance abuse history (≤2 years)。
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study of the PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Renal Function
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
- Being tested
- Remimazolam besylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam besylateDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Normal renal function group | Experimental | Not described Receives: Drug: Remimazolam besylate |
| Renal injury group | Experimental | Not described Receives: Drug: Remimazolam besylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
peak plasma concentration
Measured: 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)
Measured: Within 24 hours while receiving the study drug
t1/2
half-life
Measured: Within 24 hours while receiving the study drug
Secondary outcomes (2)
The percentage of time in the target sedation range without rescue sedation
The percentage of time in the target sedation range without rescue sedation
Measured: Within 24 hours while receiving the study drug
The number and severity of treatment emergent adverse events (TEAEs)
The number and severity of treatment emergent adverse events (TEAEs)
Measured: Within 24 hours while receiving the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start4 Nov 2023
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanically Ventilated PatientsStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153498
- Sponsor's protocol ID
- WHUICU202203
- Status last verified
- Aug 2025
- First submitted
- 23 Nov 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of the PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT06153498
- Acronym / sponsor ID
- WHUICU202203
- Conditions
- Mechanically Ventilated Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 4 Nov 2023 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal renal function group | Experimental | Drug: Remimazolam besylate |
| Renal injury group | Experimental | Drug: Remimazolam besylate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 and ≤80 years, regardless of gender;
- Anticipated requirement for mechanical ventilation and sedation ≥24 hours;
- arget sedation level within RASS score range of -3 to 0 (inclusive);
- Patients with renal impairment were defined as having a glomerular filtration rate (GFR) <90 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
Key exclusion criteria (13 listed)
- BMI<18 or >30kg/m2;
- Hypersensitivity to study drugs/opioids/reversal agents;
- Life expectancy <48 hours;
- Scheduled surgery requiring general anesthesia within 24h;
- Myasthenia gravis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remimazolam besylateAfter 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). | Drug | Normal renal function group, Renal injury group |
Primary outcome
Cmax
Time frame: Within 24 hours while receiving the study drug
peak plasma concentration
The area under the plasma drug concentration-time curve
Time frame: Within 24 hours while receiving the study drug
The area under the plasma drug concentration-time curve (AUC)
t1/2
Time frame: Within 24 hours while receiving the study drug
half-life
2 secondary outcomes
The percentage of time in the target sedation range without rescue sedation
Time frame: Within 24 hours while receiving the study drug
The number and severity of treatment emergent adverse events (TEAEs)
Time frame: Within 24 hours while receiving the study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Mechanically Ventilated Patients
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
RecruitingObservational study
Role of End-Tidal CO2 During Passive Leg Raising to Predict Fluid Responsiveness in ICU
Circulatory Failure, Critical Illness
Recruiting
Blood Flow Restriction Training for Mechanically Ventilated Patients With ICU-Acquired Weakness
Intensive Care Unit Acquired Weakness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam besylate in people with Mechanically Ventilated Patients, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Within 24 hours while receiving the study drug). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.