Can a sedative be safer for ICU patients with kidney issues?
NCT ID NCT06153498
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This trial investigates how the sedative remimazolam is processed in the bodies of ICU patients with impaired kidney function who need mechanical ventilation. It compares drug levels and safety between patients with normal and reduced kidney function. The goal is to understand if dosing adjustments are needed to achieve safe and effective sedation in this vulnerable group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- remimazolam besylate (an intravenous sedative)
- What this could lead to
- If successful, this could help doctors choose safer sedation doses for ICU patients with kidney problems, reducing risks during mechanical ventilation.
- What could go wrong
- This is a small, early-stage study (36 patients) focused on drug levels and safety, not on proving clinical benefit. Kidney impairment may alter drug effects unpredictably, and results may not apply to all ICU patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
36 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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); * 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)。
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Wuhan Union Hospital
Wuhan, Hubei, 430022, China
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