Critical IllnessPhase 2NCT05491278
Efficacy and Safety of Fospropofol Disodium Versus Propofol for Sedation in Mechanically Ventilated ICU Patients
A Phase 2 study testing Fospropofol disodium for injection and Propofol in people with Critical Illness, run by Xiaobo Yang, MD at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of fospropofol disodium for injection compared to propofol for sedation in mechanically ventilated ICU patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Fospropofol disodium for injection and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2022to 10 Sep 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged >= 18 and <= 75 years; Endotracheal intubated; Patients currently on mechanical ventilation <= 96 hours and expected to be mechanically ventilated >= 24 hours; Demand for light/moderate sedation (a RASS score of -3 to 0).
Who cannot join
- Informed Consent is unsigned； Participated in any other interventional research within 3 months; Tracheostomy; BMI <= 18 and >= 35 kilograms per square meter Pregnant; Lactant; Known or suspected allergy to various components of the study drug or to opioids and their salvage drugs, or other diseases (such as pancreatitis associated with hyperlipidemia) for which lipid emulsion should not be used; Patients who cannot be evaluated for RASS for various reasons (such as mental illness, acquired or congenital mental retardation, deafness, severe neuromuscular disease, Parkinson's disease, Huntington's disease, Alzheimer's disease, cerebrovascular disease, coma, or severe cognitive impairment due to structural diseases such as stroke, intracranial hemorrhage, head injury, malignancy, hypoxic brain injury, or cerebral edema); Patients with an expected survival period of less than 48 hours; Severe hepatic insufficiency (CTP score is 10-15 points); Chronic kidney disease (CKD grade 3 above); Unstable angina pectoris or acute myocardial infarction; Left ventricular ejection fraction <= 30%; Heart rate < 50bpm(intravenous pumping of isoproterenol <4ug/min, heart rate ≥50bpm may not be excluded); Type 2 second-degree or third-degree atrioventricular block (except those implanted a pacemaker); Two vasoconstrictors are used to maintain SBP above 90mmHg after sufficient fluid resuscitation; Myasthenia gravis; Patients with a history of drug abuse, drug abuse, alcohol abuse and long-term use of psychotropic drugs within 2 years before the screening period. Binge drinking is defined as regular drinking more than 14 times per week (1 time = 150ml of wine or 360ml of beer or 45ml of spirits);
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
About this study
The purpose of this study is to evaluate the efficacy and safety of fospropofol disodium for injection compared to propofol for sedation in mechanically ventilated ICU patients.
Read the detailed description
This is a randomized, open-label, small sample study using fospropofol disodium and propofol for sedation in mechanically ventilated ICU patients. Subjects are randomized to different treatment groups (including 1 for fospropofol disodium and 1 for propofol). Remifentanil is co-administered with fospropofol or propofol. Efficacy and safety profiles of fospropofol disodium are to be evaluated.
- Conditions
- Critical Illness
- Being tested
- Fospropofol disodium for injection, Propofol
- Keywords
- Fospropofol, Propofol, Sedation, Intensive care unit
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fospropofol disodium for injectionDrug
Also called Remifentanil
Fospropofol disodium for injection continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician.
PropofolDrug
Also called Remifentanil
Propofol for injection continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician.
| Study group | Role | What they receive |
|---|---|---|
| Fospropofol disodium for injection | Experimental | Fospropofol disodium continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for analgesia.The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician. Receives: Drug: Fospropofol disodium for injection |
| propofol | Active comparator | Propofol continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for analgesia. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time spent reaching sedation goals
Proportion of RASS assessment time points for subjects meeting target sedation levels among all RASS assessment time points during study drug administration without rescue sedation.
Measured: Within 7 days of the study began
Secondary outcomes (7)
Invasive ventilator free time within 7 days
The time without invasive ventilation within 7 days of the study began
Measured: Within 7 days of the study began
Rate of successful extubation within 7 days
The proportion of participants who experienced successful extubation within 7 days of the study began
Measured: Within 7 days of the study began
Incidence of unexpected extubation
Incidence of all extubation not planned by the attending physician
Measured: Within 7 days of the study began
Proportion of delirium in the ICU
Delirium as a percentage of all evaluable mental patients in the ICU
Measured: During ICU stay
Non-ICU survival time within 28 days
The time of survival outside of ICU within 7 days of the study began
Measured: Within 28 days of the study began
Case fatality rate within 28 days
After follow-up, the fatality rates of all enrolled patients (including those still in ICU, transferred out and discharge) within 28 days of the study began
Measured: Within 28 days of the study began
Percentage of time spent that trial drug was discontinued due to adverse events
Percentage of time the trial drug was discontinued due to any adverse event suspected to be related to the trial drug
Measured: Within 7 days of the study began
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start10 Aug 2022
- Primary completion15 Jun 2023
- Study completion10 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaobo Yang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaobo Yang, MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491278
- Sponsor's protocol ID
- WUHICU202206
- Status last verified
- Sep 2022
- First submitted
- 5 Aug 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fospropofol Disodium Versus Propofol for Sedation in Mechanically Ventilated ICU Patients
- ClinicalTrials.gov ID
- NCT05491278
- Acronym / sponsor ID
- WUHICU202206
- Conditions
- Critical Illness
- Keywords
- Fospropofol, Propofol, Sedation, Intensive care unit
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Xiaobo Yang, MDUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 8 Aug 2022 (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.
The purpose of this study is to evaluate the efficacy and safety of fospropofol disodium for injection compared to propofol for sedation in mechanically ventilated ICU patients.
Detailed description
This is a randomized, open-label, small sample study using fospropofol disodium and propofol for sedation in mechanically ventilated ICU patients. Subjects are randomized to different treatment groups (including 1 for fospropofol disodium and 1 for propofol). Remifentanil is co-administered with fospropofol or propofol. Efficacy and safety profiles of fospropofol disodium are to be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fospropofol disodium for injection | Experimental | Drug: Fospropofol disodium for injectionFospropofol disodium continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for analgesia.The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician. |
| propofol | Active comparator | Drug: PropofolPropofol continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for analgesia. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged >= 18 and <= 75 years; Endotracheal intubated; Patients currently on mechanical ventilation <= 96 hours and expected to be mechanically ventilated >= 24 hours; Demand for light/moderate sedation (a RASS score of -3 to 0).
Key exclusion criteria (1 listed)
- Informed Consent is unsigned； Participated in any other interventional research within 3 months; Tracheostomy; BMI <= 18 and >= 35 kilograms per square meter Pregnant; Lactant; Known or suspected allergy to various components of the study drug or to opioids and their salvage drugs, or other diseases (such as pancreatitis associated with hyperlipidemia) for which lipid emulsion should not be used; Patients who cannot be evaluated for RASS for various reasons (such as mental illness, acquired or congenital mental retardation, deafness, severe neuromuscular disease, Parkinson's disease, Huntington's disease, Alzheimer's disease, cerebrovascular disease, coma, or severe cognitive impairment due to structural diseases such as stroke, intracranial hemorrhage, head injury, malignancy, hypoxic brain injury, or cerebral edema); Patients with an expected survival period of less than 48 hours; Severe hepatic insufficiency (CTP score is 10-15 points); Chronic kidney disease (CKD grade 3 above); Unstable angina pectoris or acute myocardial infarction; Left ventricular ejection fraction <= 30%; Heart rate < 50bpm(intravenous pumping of isoproterenol <4ug/min, heart rate ≥50bpm may not be excluded); Type 2 second-degree or third-degree atrioventricular block (except those implanted a pacemaker); Two vasoconstrictors are used to maintain SBP above 90mmHg after sufficient fluid resuscitation; Myasthenia gravis; Patients with a history of drug abuse, drug abuse, alcohol abuse and long-term use of psychotropic drugs within 2 years before the screening period. Binge drinking is defined as regular drinking more than 14 times per week (1 time = 150ml of wine or 360ml of beer or 45ml of spirits);
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 |
|---|---|---|
| Fospropofol disodium for injectionAlso: RemifentanilFospropofol disodium for injection continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician. | Drug | Fospropofol disodium for injection |
| PropofolAlso: RemifentanilPropofol for injection continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician. | Drug | propofol |
Primary outcome
Percentage of time spent reaching sedation goals
Time frame: Within 7 days of the study began
Proportion of RASS assessment time points for subjects meeting target sedation levels among all RASS assessment time points during study drug administration without rescue sedation.
7 secondary outcomes
Invasive ventilator free time within 7 days
Time frame: Within 7 days of the study began
Rate of successful extubation within 7 days
Time frame: Within 7 days of the study began
Incidence of unexpected extubation
Time frame: Within 7 days of the study began
Proportion of delirium in the ICU
Time frame: During ICU stay
Non-ICU survival time within 28 days
Time frame: Within 28 days of the study began
Case fatality rate within 28 days
Time frame: Within 28 days of the study began
Percentage of time spent that trial drug was discontinued due to adverse events
Time frame: Within 7 days of the study began
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 21 Sep 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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 Fospropofol disodium for injection and Propofol in people with Critical Illness, run by Xiaobo Yang, MD 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 1 inclusion and 1 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 21 Sep 2023. 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?
Percentage of time spent reaching sedation goals (time frame: Within 7 days of the study began). 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 21 Sep 2023.