Sedation in Intensive CarePhase 2NCT04669821
A Clinical Study Evaluating Sedation of Intravenous Administration of HSK3486 in ICU Patients Undergoing Long-Term Mechanical Ventilation
A Phase 2 study testing HSK3486 and Propofol in people with Sedation in Intensive Care, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is a multi-center, randomized, open-label, propofol-controlled exploratory clinical study. In this study, 20 ICU patients undergoing mechanical ventilation are expected to be enrolled and will be randomly assigned to the HSK3486 group and the propofol group in a 1:1 ratio. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sedation in Intensive Care
- What is being tested?
- HSK3486 and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2021to 9 Oct 2021
- Phase
- Phase 2
- 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
- Patients who require tracheal intubation for mechanical ventilation, with expected sedation duration of longer than 96 h;
- Patients requiring a target RASS score of -1 to -2 for sedation;
- Aged ≥ 18 and < 80 years old, with no gender requirement;
- BMI ≥ 18 kg/m2 and ≤ 30 kg/m2;
- The patients or their family members fully understand the objectives and significance of this study, and voluntarily participate in this clinical study and sign the informed consent form.
Who cannot join
- Patients known to be allergic to eggs, soy products, opioids and their antidotes, and Propofol; patient having contraindications to Propofol, opioids and their antidotes;
- Patients who have received propofol for more than 3 days in the ICU or in the general ward before being transferred to the ICU before signing informed consent form;
- Patients having the following medical history or evidence of any of the following at screening, which may increase sedation/anesthesia risk:
- Cardiovascular system: New York Heart Association (NYHA) Class III and IV heart failure, Adams-stokes syndrome; acute coronary syndrome (ACS) that occurs within 6 months before screening; bradycardia requiring medication and/or heart rate ≤ 50 beats/min; a history of severe arrhythmia such as II-III degree atrioventricular block (excluding patients using pacemakers); acute and chronic myocarditis;
- Patients with hyperlipidemia: Defined as patients with TC ≥ 5.2 mmol/L or LDL-C ≥ 3.4 mmol/L at screening, or patients with severely increased blood pressure or blood glucose despite their blood lipid levels meeting the requirements, rendering the patients huge risk of cardiovascular diseases per the investigator's judgment; patients with acute pancreatitis;
- Patients with mental diseases (e.g., schizophrenia, depression) and cognitive dysfunction; grand mal epilepsy and convulsion; head injury, intracranial hypertension, cerebral aneurysm; Glasgow Coma Score (GCS) ≤ 12; SOFA Score > 9; past history of psychotropic and narcotic drug abuse; history of alcohol abuse within 3 months before screening; long-term use of psychotropic drugs;
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- Patients with high paraplegia and general paralysis; patients with unstable hemodynamics;
- Severe hepatic and renal insufficiency (liver function: refer to child-pugh grade C; renal function: glomerular filtration rate eGFR ≤ 30 mL/(min•1.73 m2) [eGFR is calculated using the Modification of Diet in Renal Disease (MDRD) equation: eGFR = 175 × serum creatinine (SCr)-1.234 × age-0.179 × 0.79 (females)]; patients undergoing dialysis;
- Patients with an expected survival of less than 1 week;
- Other situations unsuitable for enrollment per the investigator's consideration.
- Pregnant or breastfeeding females: women or men of child-bearing potential who are unwilling to use contraception during the trial; subjects who are planning pregnancy within 1 month after the trial starts (including male subjects);
- Have participated in any other clinical trials within 1 month prior to screening;
- Other conditions that patients are judged by the investigator to be unsuitable for participating in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang
About this study
Official title: A Multi-Center, Randomized, Open-Label, Propofol-Controlled Exploratory Clinical Study Evaluating Sedation of Intravenous Administration of HSK3486 Injectable Emulsion in ICU Patients Undergoing Long-Term Mechanical Ventilation
This is a multi-center, randomized, open-label, propofol-controlled exploratory clinical study. In this study, 20 ICU patients undergoing mechanical ventilation are expected to be enrolled and will be randomly assigned to the HSK3486 group and the propofol group in a 1:1 ratio. This study is not blinded as it is open-label.
- Conditions
- Sedation in Intensive Care
- Being tested
- HSK3486, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK3486Drug
Loading Dose：0.1 mg/kg，Maintenance Dose：Maintenance is started at 0.3 mg/kg/h, and the dose can be adjusted up and down by 0.05-0.1 mg/kg/h.
PropofolDrug
Loading Dose：0.5 mg/kg，Maintenance Dose：Maintenance is started at1.5 mg/kg/h, and the dose can be adjusted up and down by 0.25-0.5mg/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| HSK3486 | Experimental | Not described Receives: Drug: HSK3486 |
| Propofol | Active comparator | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean duration of qualified sedation
the mean duration of RASS being in the range of -1 to -2 per hour during the study medication provided that no remedial medication is used
Measured: Within 96hours of administration
Secondary outcomes (2)
Time to recovery
the time for the subject to recover from sedation to full recovery of consciousness (RASS ≥ 0) after discontinuation of drug administration.
Measured: Within 24 hours after administration
Time to extubation
the time from intubation (applicable to patients who undergoes intubation after entering the ICU)/ICU admission (applicable to patients with intubation before entering the ICU) to extubation or the time from drug discontinuation to extubation
Measured: Within 24 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start9 Mar 2021
- Primary completion28 Aug 2021
- Study completion9 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedation in Intensive CareStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669821
- Sponsor's protocol ID
- HSK3486-206
- Status last verified
- May 2022
- First submitted
- 30 Nov 2020
- Last updated
- 27 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Open-Label, Propofol-Controlled Exploratory Clinical Study Evaluating Sedation of Intravenous Administration of HSK3486 Injectable Emulsion in ICU Patients Undergoing Long-Term Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04669821
- Acronym / sponsor ID
- HSK3486-206
- Conditions
- Sedation in Intensive Care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 28 Aug 2021 (actual)
- Study completion
- 9 Oct 2021 (actual)
- First posted
- 17 Dec 2020 (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.
This is a multi-center, randomized, open-label, propofol-controlled exploratory clinical study. In this study, 20 ICU patients undergoing mechanical ventilation are expected to be enrolled and will be randomly assigned to the HSK3486 group and the propofol group in a 1:1 ratio. This study is not blinded as it is open-label.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK3486 | Experimental | Drug: HSK3486 |
| Propofol | Active comparator | Drug: Propofol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who require tracheal intubation for mechanical ventilation, with expected sedation duration of longer than 96 h;
- Patients requiring a target RASS score of -1 to -2 for sedation;
- Aged ≥ 18 and < 80 years old, with no gender requirement;
- BMI ≥ 18 kg/m2 and ≤ 30 kg/m2;
- The patients or their family members fully understand the objectives and significance of this study, and voluntarily participate in this clinical study and sign the informed consent form.
Key exclusion criteria (13 listed)
- Patients known to be allergic to eggs, soy products, opioids and their antidotes, and Propofol; patient having contraindications to Propofol, opioids and their antidotes;
- Patients who have received propofol for more than 3 days in the ICU or in the general ward before being transferred to the ICU before signing informed consent form;
- Patients having the following medical history or evidence of any of the following at screening, which may increase sedation/anesthesia risk:
- Pregnant or breastfeeding females: women or men of child-bearing potential who are unwilling to use contraception during the trial; subjects who are planning pregnancy within 1 month after the trial starts (including male subjects);
- Have participated in any other clinical trials within 1 month prior to screening;
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 |
|---|---|---|
| HSK3486Loading Dose：0.1 mg/kg，Maintenance Dose：Maintenance is started at 0.3 mg/kg/h, and the dose can be adjusted up and down by 0.05-0.1 mg/kg/h. | Drug | HSK3486 |
| PropofolLoading Dose：0.5 mg/kg，Maintenance Dose：Maintenance is started at1.5 mg/kg/h, and the dose can be adjusted up and down by 0.25-0.5mg/kg/h. | Drug | Propofol |
Primary outcome
Mean duration of qualified sedation
Time frame: Within 96hours of administration
the mean duration of RASS being in the range of -1 to -2 per hour during the study medication provided that no remedial medication is used
2 secondary outcomes
Time to recovery
Time frame: Within 24 hours after administration
Time to extubation
Time frame: Within 24 hours after administration
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 27 May 2022.
Related trials for Sedation in Intensive Care
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Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
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Dexametedomidine Ketamine Infusion Versus Dexametedomidine Propofol Infusion in Non-compliant Agitated Patients on Continuous Positive Airway Pressure (CPAP) Mask Ventilation in the Intensive Care Unit
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Remimazolam vs Propofol for Long-Term Sedation in Mechanically Ventilated ICU Patients
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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 Phase 2 study testing HSK3486 and Propofol in people with Sedation in Intensive Care, run by Haisco Pharmaceutical Group Co., Ltd. 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 5 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 27 May 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean duration of qualified sedation (time frame: Within 96hours of administration). 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 27 May 2022.