EsketaminePhase 4NCT04843982
Immunoinflammatory Regulation of Esketamine in Septic Patients
A Phase 4 study testing Esketamine hydrochloride in people with Esketamine and Sepsis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Studies have shown that excessive systemic inflammatory response and concomitant immunosuppression are the main cause of early death in patients with sepsis. Therefore, it is very important to reduce excessive inflammation and improve immunosuppression in the acute phase of sepsis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esketamine, Sepsis, Inflammatory Response
- What is being tested?
- Esketamine hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2021to 1 Jan 2026
- Phase
- Phase 4
- 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
- 18 years old ≤ age ≤60 years old;
- SOFA score ≥2;
- Mechanical ventilation should be required for at least 24 hours when included in the study;
- Informed consent is obtained.
Who cannot join
- Age < 18 years old or ≥ 60 years old;
- Previous solid organ or bone marrow transplantation;
- Autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.), or hematologic malignancies (leukemia and lymphoma, etc.);
- Received radiotherapy or chemotherapy within the past 30 days, or received immunosuppressant drugs (tripterygium wilfordii, mycophenolate mofetil, cyclophosphamide, FK506, etc.), or continuous treatment with prednisolone more than 10 mg/day (or equivalent doses of the other hormones);
- Unstable angina pectoris or myocardial infarction in the past six months;
- Acute brain injury (traumatic brain injury, subarachnoid hemorrhage, acute ischemic stroke, acute intracranial hemorrhage, acute intracranial infection, etc.);
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- Poorly controlled hypertension and congestive heart failure;
- Increased intraocular or intracranial pressure;
- Chronic kidney disease, received continuous renal replacement therapy in the past 30 days, or acute renal failure requiring CRRT;
- Severe chronic liver disease (Child-Pugh class B or C);
- Alcohol dependence, mental illness or severe cognitive impairment;
- Pregnancy or lactation;
- Informed consent is not obtained.
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, Hubei, 430022
About this study
Official title: Effects of Esketamine Combined With Propofol for Sedation on Systemic Inflammation and Immune Function in Septic Patients in the ICU: a Single-center, Non-blind, Prospective Randomized Controlled Trial
Studies have shown that excessive systemic inflammatory response and concomitant immunosuppression are the main cause of early death in patients with sepsis. Therefore, it is very important to reduce excessive inflammation and improve immunosuppression in the acute phase of sepsis. Clinical studies have shown that esketamine combined with propofol for sedation has been proven to be safe and effective for septic patients in the ICU due to its cardiovascular stability. Previous studies have demonstrated that esketamine has anti-inflammatory effects against depression and surgical stress. Our preliminary experimental studies have found that esketamine had strong anti-inflammatory effects in the acute phase of sepsis. However, it is not clear whether esketamine could reduce excessive inflammation and improve immunosuppression in septic patients primarily sedated with a continuous infusion of propofol.
This intervention study is to investigate whether three consecutive days of intravenous esketamine infusions via infusion pump (0.07 mg/kg/h) could reduce excessive inflammation and improve immunosuppression in septic patients requiring mechanical ventilation in the ICU under sedation primarily with propofol.
- Conditions
- Esketamine, Sepsis, Inflammatory Response, Immunosuppression
- Being tested
- Esketamine hydrochloride
- Keywords
- Esketamine, Sepsis, Inflammatory Response, Immunosuppression
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine hydrochlorideDrug
After inclusion, septic patients will be received a single intravenous injection of esketamine (0.7 mg/kg), and then followed by an intravenous administration of esketamine (0.07 mg/kg/h) with an infusion pump for three consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| esketamine plus propofol | Experimental | After inclusion, patients are sedated primarily with propofol (0-3 mg/kg/h) using a microinfusion pump and adjusted according to the depth of sedation (Richmond Agitation Sedation Scale (RASS): 0 to -2).
After inclusion, septic patients will be received a single intravenous injection of esketamine (0.7 mg/kg), and then followed by an intravenous administration of esketamine (0.07 mg/kg/h) with an infusion pump for three consecutive days. Receives: Drug: Esketamine hydrochloride |
| propofol | No intervention | After inclusion, patients are sedated primarily with propofol (0-3 mg/kg/h) using a microinfusion pump and adjusted according to the depth of sedation (Richmond Agitation Sedation Scale (RASS): 0 to -2). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of inflammatory cytokines (0 h)
Interleukin (IL)-6, tumor necrosis factor (TNF)-α, IL-2, IL-4, IL-10, IL-17A, and interferon (IFN)-γ
Measured: 0 hour after study inclusion
Serum concentration of inflammatory cytokines (48 h)
IL-6, TNF-α, IL-2, IL-4, IL-10, IL-17A, and IFN-γ
Measured: 48 hours after study inclusion
Serum concentration of inflammatory cytokines (72 h)
IL-6, TNF-α, IL-2, IL-4, IL-10, IL-17A, and IFN-γ
Measured: 72 hours after study inclusion
Absolute number of lymphocyte subsets in the peripheral blood (0 h)
CD3(+), CD3(+) CD4(+), CD3(+) CD8(+), CD3(-) CD16(+) CD56(+) , and CD19(+) cells
Measured: 0 hour after study inclusion
Absolute number of lymphocyte subsets in the peripheral blood (48 h)
CD3(+), CD3(+) CD4(+), CD3(+) CD8(+), CD3(-) CD16(+) CD56(+) , and CD19(+) cells
Measured: 48 hours after study inclusion
Absolute number of lymphocyte subsets in the peripheral blood (72 h)
CD3(+), CD3(+) CD4(+), CD3(+) CD8(+), CD3(-) CD16(+) CD56(+) , and CD19(+) cells
Measured: 72 hours after study inclusion
ICU length of stay
Length of stay in the ICU
Measured: up to 8 weeks
Secondary outcomes (22)
Serum concentration of atrial natriuretic peptide (ANP) (0 h)
ANP is secreted primarily by atrial cardiomyocytes
Measured: 0 hour after study inclusion
Serum concentration of atrial natriuretic peptide (ANP) (48h)
ANP is secreted primarily by atrial cardiomyocytes
Measured: 48 hours after study inclusion
Serum concentration of atrial natriuretic peptide (ANP) (72h)
ANP is secreted primarily by atrial cardiomyocytes
Measured: 72 hours after study inclusion
Acute physiology and chronic health evaluation (APACHE) Ⅱ score
0-67, higher scores correspond to more severe disease and a higher risk of death
Measured: 0 hour after study inclusion
Acute physiology and chronic health evaluation (APACHE) Ⅱ score
0-67, higher scores correspond to more severe disease and a higher risk of death
Measured: 24 hours after study inclusion
Acute physiology and chronic health evaluation (APACHE) Ⅱ score
0-67, higher scores correspond to more severe disease and a higher risk of death
Measured: 48 hours after study inclusion
Acute physiology and chronic health evaluation (APACHE) Ⅱ score
0-67, higher scores correspond to more severe disease and a higher risk of death
Measured: 72 hours after study inclusion
Sequential organ failure assessment (SOFA) score
0-43, higher scores correspond to more severe sepsis
Measured: 0 hour after study inclusion
Sequential organ failure assessment (SOFA) score
0-43, higher scores correspond to more severe sepsis
Measured: 24 hours after study inclusion
Sequential organ failure assessment (SOFA) score
0-43, higher scores correspond to more severe sepsis
Measured: 48 hours after study inclusion
Sequential organ failure assessment (SOFA) score
0-43, higher scores correspond to more severe sepsis
Measured: 72 hours after study inclusion
Mechanical ventilation time after inclusion
Patients requiring mechanical ventilation after study inclusion
Measured: Up to 8 weeks
Total hospital length of stay
Total length of hospital stay
Measured: Through study completion, an average of 2 year
Infection complications
Pulmonary infection, urinary tract infection, bloodstream infections, etc
Measured: Through study completion, an average of 2 year
In-hospital mortality
Mortality rates for the entire period of hospitalization
Measured: Through study completion, an average of 2 year
90-day readmission rate
Percentage of readmission to hospital within 90 days of study inclusion
Measured: Through study completion, an average of 2 year
CCL1 expression in alveolar macrophages (0 h)
CCL1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
Measured: 0 hour after study inclusion
CCL1 expression in alveolar macrophages (24 h)
CCL1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
Measured: 24 hours after study inclusion
CCL1 expression in alveolar macrophages (72 h)
CCL1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
Measured: 72 hours after study inclusion
expression of WNT pathway proteins in alveolar macrophages (0 h)
Wnt5a, FZD5, b-catenin, Lef1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
Measured: 0 hour after study inclusion
expression of WNT pathway proteins in alveolar macrophages (24 h)
Wnt5a, FZD5, b-catenin, Lef1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
Measured: 24 hours after study inclusion
expression of WNT pathway proteins in alveolar macrophages (72 h)
Wnt5a, FZD5, b-catenin, Lef1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
Measured: 72 hours after study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start28 Jul 2021
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Why it stopped: Due to changes in the study plan, no significant clinical benefit was observed, but no adverse events occurred either.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsketamineStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shiying Yuan, PhD, MD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843982
- Sponsor's protocol ID
- YSY202001
- Status last verified
- Jul 2025
- First submitted
- 29 Mar 2021
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the completion of the study, the original data will be sent to the email address: zhjcheng1@163.com, and the password will be provided after the paper is published.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Esketamine Combined With Propofol for Sedation on Systemic Inflammation and Immune Function in Septic Patients in the ICU: a Single-center, Non-blind, Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04843982
- Acronym / sponsor ID
- YSY202001
- Conditions
- Esketamine, Sepsis, Inflammatory Response, Immunosuppression
- Keywords
- Esketamine, Sepsis, Inflammatory Response, Immunosuppression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to changes in the study plan, no significant clinical benefit was observed, but no adverse events occurred either.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 14 Apr 2021 (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.
Studies have shown that excessive systemic inflammatory response and concomitant immunosuppression are the main cause of early death in patients with sepsis. Therefore, it is very important to reduce excessive inflammation and improve immunosuppression in the acute phase of sepsis. Clinical studies have shown that esketamine combined with propofol for sedation has been proven to be safe and effective for septic patients in the ICU due to its cardiovascular stability. Previous studies have demonstrated that esketamine has anti-inflammatory effects against depression and surgical stress. Our preliminary experimental studies have found that esketamine had strong anti-inflammatory effects in the acute phase of sepsis. However, it is not clear whether esketamine could reduce excessive inflammation and improve immunosuppression in septic patients primarily sedated with a continuous infusion of propofol.
This intervention study is to investigate whether three consecutive days of intravenous esketamine infusions via infusion pump (0.07 mg/kg/h) could reduce excessive inflammation and improve immunosuppression in septic patients requiring mechanical ventilation in the ICU under sedation primarily with propofol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| esketamine plus propofol | Experimental | Drug: Esketamine hydrochlorideAfter inclusion, patients are sedated primarily with propofol (0-3 mg/kg/h) using a microinfusion pump and adjusted according to the depth of sedation (Richmond Agitation Sedation Scale (RASS): 0 to -2). After inclusion, septic patients will be received a single intravenous injection of esketamine (0.7 mg/kg), and then followed by an intravenous administration of esketamine (0.07 mg/kg/h) with an infusion pump for three consecutive days. |
| propofol | No intervention | –After inclusion, patients are sedated primarily with propofol (0-3 mg/kg/h) using a microinfusion pump and adjusted according to the depth of sedation (Richmond Agitation Sedation Scale (RASS): 0 to -2). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old ≤ age ≤60 years old;
- SOFA score ≥2;
- Mechanical ventilation should be required for at least 24 hours when included in the study;
- Informed consent is obtained.
Key exclusion criteria (13 listed)
- Age < 18 years old or ≥ 60 years old;
- Previous solid organ or bone marrow transplantation;
- Autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.), or hematologic malignancies (leukemia and lymphoma, etc.);
- Received radiotherapy or chemotherapy within the past 30 days, or received immunosuppressant drugs (tripterygium wilfordii, mycophenolate mofetil, cyclophosphamide, FK506, etc.), or continuous treatment with prednisolone more than 10 mg/day (or equivalent doses of the other hormones);
- Unstable angina pectoris or myocardial infarction in the past six months;
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 |
|---|---|---|
| Esketamine hydrochlorideAfter inclusion, septic patients will be received a single intravenous injection of esketamine (0.7 mg/kg), and then followed by an intravenous administration of esketamine (0.07 mg/kg/h) with an infusion pump for three consecutive days. | Drug | esketamine plus propofol |
Primary outcome
Serum concentration of inflammatory cytokines (0 h)
Time frame: 0 hour after study inclusion
Interleukin (IL)-6, tumor necrosis factor (TNF)-α, IL-2, IL-4, IL-10, IL-17A, and interferon (IFN)-γ
Serum concentration of inflammatory cytokines (48 h)
Time frame: 48 hours after study inclusion
IL-6, TNF-α, IL-2, IL-4, IL-10, IL-17A, and IFN-γ
Serum concentration of inflammatory cytokines (72 h)
Time frame: 72 hours after study inclusion
IL-6, TNF-α, IL-2, IL-4, IL-10, IL-17A, and IFN-γ
Absolute number of lymphocyte subsets in the peripheral blood (0 h)
Time frame: 0 hour after study inclusion
CD3(+), CD3(+) CD4(+), CD3(+) CD8(+), CD3(-) CD16(+) CD56(+) , and CD19(+) cells
Absolute number of lymphocyte subsets in the peripheral blood (48 h)
Time frame: 48 hours after study inclusion
CD3(+), CD3(+) CD4(+), CD3(+) CD8(+), CD3(-) CD16(+) CD56(+) , and CD19(+) cells
Absolute number of lymphocyte subsets in the peripheral blood (72 h)
Time frame: 72 hours after study inclusion
CD3(+), CD3(+) CD4(+), CD3(+) CD8(+), CD3(-) CD16(+) CD56(+) , and CD19(+) cells
ICU length of stay
Time frame: up to 8 weeks
Length of stay in the ICU
22 secondary outcomes
Serum concentration of atrial natriuretic peptide (ANP) (0 h)
Time frame: 0 hour after study inclusion
Serum concentration of atrial natriuretic peptide (ANP) (48h)
Time frame: 48 hours after study inclusion
Serum concentration of atrial natriuretic peptide (ANP) (72h)
Time frame: 72 hours after study inclusion
Acute physiology and chronic health evaluation (APACHE) Ⅱ score
Time frame: 0 hour after study inclusion
Acute physiology and chronic health evaluation (APACHE) Ⅱ score
Time frame: 24 hours after study inclusion
Acute physiology and chronic health evaluation (APACHE) Ⅱ score
Time frame: 48 hours after study inclusion
Acute physiology and chronic health evaluation (APACHE) Ⅱ score
Time frame: 72 hours after study inclusion
Sequential organ failure assessment (SOFA) score
Time frame: 0 hour after study inclusion
Sequential organ failure assessment (SOFA) score
Time frame: 24 hours after study inclusion
Sequential organ failure assessment (SOFA) score
Time frame: 48 hours after study inclusion
Sequential organ failure assessment (SOFA) score
Time frame: 72 hours after study inclusion
Mechanical ventilation time after inclusion
Time frame: Up to 8 weeks
Total hospital length of stay
Time frame: Through study completion, an average of 2 year
Infection complications
Time frame: Through study completion, an average of 2 year
In-hospital mortality
Time frame: Through study completion, an average of 2 year
90-day readmission rate
Time frame: Through study completion, an average of 2 year
CCL1 expression in alveolar macrophages (0 h)
Time frame: 0 hour after study inclusion
CCL1 expression in alveolar macrophages (24 h)
Time frame: 24 hours after study inclusion
CCL1 expression in alveolar macrophages (72 h)
Time frame: 72 hours after study inclusion
expression of WNT pathway proteins in alveolar macrophages (0 h)
Time frame: 0 hour after study inclusion
expression of WNT pathway proteins in alveolar macrophages (24 h)
Time frame: 24 hours after study inclusion
expression of WNT pathway proteins in alveolar macrophages (72 h)
Time frame: 72 hours after study inclusion
Results and safety
The study was stopped early (reason given: Due to changes in the study plan, no significant clinical benefit was observed, but no adverse events occurred either.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. After the completion of the study, the original data will be sent to the email address: zhjcheng1@163.com, and the password will be provided after the paper is published.
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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.
Shiying Yuan, PhD, MD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esketamine hydrochloride in people with Esketamine and Sepsis, 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: stopped early, as of the sponsor's last update on 30 Sep 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Due to changes in the study plan, no significant clinical benefit was observed, but no adverse events occurred either.). Results are not available in the source record.
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?
Serum concentration of inflammatory cytokines (0 h) (time frame: 0 hour after study inclusion). The study lists 7 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 30 Sep 2026.