- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04147416
A Study Evaluating the Efficacy and Safety of HSK3486 for Sedation
May 25, 2022 updated by: Sichuan Haisco Pharmaceutical Group Co., Ltd
A Multi-center, Open-label, Randomized, Propofol-controlled Study Evaluating the Efficacy and Safety of Intravenous Administration of HSK3486 Injectable Emulsion for Sedation in Intensive Care (ICU) Patients Undergoing Mechanical Ventilation
This is a multi-center, open-label, randomized, propofol-controlled phase II clinical trial.A total of ICU patients undergoing mechanical ventilation are intended to be enrolled and randomly assigned to HSK3486 group and propofol group in a 2:1 ratio.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guanzhou, Guangdong, China
- The First Affiliated Hospital of Sun Yat-sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who need tracheal intubation for mechanical ventilation and need 6-24 h of sedation after randomization, as anticipated;
- The target RASS score is between +1 and -2;
- 18 ≤ age < 80 years old; with no restriction on gender;
- 18 kg/m2 ≤ BMI ≤ 30 kg/m2;
- The patients or their family members well understand the purpose and significance of the trial, voluntarily participate in this clinical trial, and sign the informed consent form.
Exclusion Criteria:
- Patients known to be allergic to eggs, soy products, opioids and their antidotes, and propofol; patients having contraindications to propofol, opioids and their antidotes;
Patients having the following medical history or evidence at screening, which may increase sedation/anesthesia risk:
- Cardiovascular system: Class III and IV heart failure by New York Heart Association (NYHA), Adams-Stokes syndrome; acute coronary syndrome (ACS) within 6 months prior to screening; bradycardia requiring medications and/or heart rate ≤ 50 beats/min; serious arrhythmia history such as Degree II-III atrioventricular block (excluding patients with pacemakers); acute and chronic myocarditis; systolic pressure ≤ 90 mmHg even when large dose of vasoactive drug (such as norepinephrine ≥ 0.6 μg/kg/min) is used;
- Patients with mental disorders (such as schizophrenia, depression, etc.) and cognitive impairment; past abuse history of psychotropics and anesthetics, and long-term use of psychotropics;
- Patients with moderate to severe hepatic and renal dysfunctions (liver function: Child-Pugh Grade B and C, scale in Annex 9; renal function: glomerular filtration rate eGFR ≤ 60 mL/(min•1.73 m2) [eGFR is calculated with the Modification of Diet in Renal Disease (MDRD) formula: eGFR = 186 × serum creatinine (SCr)-1.154 × age-0.203 × 0.742 (female)]; patients under dialysis;
- Epileptic seizures, convulsions; craniocerebral injury, intracranial hypertension, cerebral aneurysms; Glasgow Coma Score (GCS) ≤ 12 (scale in Annex 6); SOFA > 9 (scale in Annex 7);
- Expected survival ≤ 72 h;
Laboratory measures at screening period meet the following criteria:
- Neutrophil count ≤ 1.0 × 10^9/L;
- Platelet count ≤ 50 × 10^9/L;
- Hemoglobin ≤ 70 g/L;
- Pregnant or lactating females; fertile females or males reluctant to receive contraception through the study; any subject planning for pregnancy within 1 month after the study (including male subject);
- Participated in other drug clinical trials within 1 month prior to screening; Other reasons rendering a subject unsuitable for participation in this study as per the judgment of the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HSK3486
HSK3486 for Sedation
|
Administered with HSK3486 at a loading dose of 0.1-0.2
mg/kg via intravenous pump.
Then HSK3486 shall be administered immediately at an initial maintenance dose of 0.3 mg/kg/h respectively.
|
Active Comparator: Propofol
Propofol for Sedation
|
Administered with Propofol at a loading dose of 0.5-1.0mg/kg
via intravenous pump.
Then Propofol shall be administered immediately at an initial maintenance dose of 1.5 mg/kg/h respectively.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean time to sedation
Time Frame: at day 1
|
Defined as the mean time during which the hourly RASS is in the range of +1- -2 during the study treatment
|
at day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Study drug use
Time Frame: at day 1
|
Including the loading dose, maintenance dose, additional dose of HSK3486 and propofol, average unit weight dose per hour of HSK3486 or propofol, total and hourly average numbers of dose adjustments
|
at day 1
|
Minimum maintenance dose
Time Frame: at day 1
|
Defined as the minimum dose to maintain the target sedation level (RASS between +1 and -2) of the subject for ≥ 2 h and ≥ 4 h during the administration period
|
at day 1
|
Unit weight dose of remedial drug
Time Frame: at day 1
|
Defined as the average hourly unit weight dose of sedatives other than propofol administered for maintaining a target sedation level (RASS between +1 and -2) during the administration period
|
at day 1
|
Unit weight dose of remifentanil
Time Frame: at day 1
|
Defined as the average hourly unit weight dose of remifentanil for analgesia during the administration period
|
at day 1
|
Extubation time
Time Frame: at day 1
|
Defined as the time from ICU admission to extubation (applicable for subjects who have been intubated before admitted to ICU) or the time from intubation to extubation (applicable for subjects who are intubated after admitted to ICU); for withdrawals, the time of extubation is calculated according to the time of discontinuation; if the extubation does not occur within 24 h of administration, the time of extubation is recorded as 24 h
|
at day 1
|
Recovery time
Time Frame: at day 1
|
Defined as the time to recover from sedation status to awaken status (RASS ≥ 0) after drug discontinuation, accurate to the minute; if RASS is ≥ 0 at discontinuation, the recovery time is recorded as 0
|
at day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 22, 2019
Primary Completion (Actual)
May 31, 2020
Study Completion (Actual)
July 3, 2020
Study Registration Dates
First Submitted
October 30, 2019
First Submitted That Met QC Criteria
October 30, 2019
First Posted (Actual)
November 1, 2019
Study Record Updates
Last Update Posted (Actual)
May 27, 2022
Last Update Submitted That Met QC Criteria
May 25, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSK3486-205
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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