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Regolazione immunoinfiammatoria dell'esketamina nei pazienti settici

27 settembre 2026 aggiornato da: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Effetti dell'esketamina in combinazione con il propofol per la sedazione sull'infiammazione sistemica e sulla funzione immunitaria nei pazienti settici in terapia intensiva: uno studio prospettico randomizzato controllato a centro singolo, non cieco

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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

10

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Hubei
      • Wuhan, Hubei, Cina, 430022
        • Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.);
  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: esketamine plus propofol

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.
Droga: Esketamine hydrochloride

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.
Nessun intervento: propofol

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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Serum concentration of inflammatory cytokines (0 h)
Lasso di tempo: 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
0 hour after study inclusion
Serum concentration of inflammatory cytokines (48 h)
Lasso di tempo: 48 hours after study inclusion

IL-6, TNF-α, IL-2, IL-4, IL-10, IL-17A, and IFN-γ
48 hours after study inclusion
Serum concentration of inflammatory cytokines (72 h)
Lasso di tempo: 72 hours after study inclusion

IL-6, TNF-α, IL-2, IL-4, IL-10, IL-17A, and IFN-γ
72 hours after study inclusion
Absolute number of lymphocyte subsets in the peripheral blood (0 h)
Lasso di tempo: 0 hour after study inclusion

CD3(+), CD3(+) CD4(+), CD3(+) CD8(+), CD3(-) CD16(+) CD56(+) , and CD19(+) cells
0 hour after study inclusion
Absolute number of lymphocyte subsets in the peripheral blood (48 h)
Lasso di tempo: 48 hours after study inclusion

CD3(+), CD3(+) CD4(+), CD3(+) CD8(+), CD3(-) CD16(+) CD56(+) , and CD19(+) cells
48 hours after study inclusion
Absolute number of lymphocyte subsets in the peripheral blood (72 h)
Lasso di tempo: 72 hours after study inclusion

CD3(+), CD3(+) CD4(+), CD3(+) CD8(+), CD3(-) CD16(+) CD56(+) , and CD19(+) cells
72 hours after study inclusion
ICU length of stay
Lasso di tempo: up to 8 weeks

Length of stay in the ICU
up to 8 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Serum concentration of atrial natriuretic peptide (ANP) (0 h)
Lasso di tempo: 0 hour after study inclusion

ANP is secreted primarily by atrial cardiomyocytes
0 hour after study inclusion
Serum concentration of atrial natriuretic peptide (ANP) (48h)
Lasso di tempo: 48 hours after study inclusion

ANP is secreted primarily by atrial cardiomyocytes
48 hours after study inclusion
Serum concentration of atrial natriuretic peptide (ANP) (72h)
Lasso di tempo: 72 hours after study inclusion

ANP is secreted primarily by atrial cardiomyocytes
72 hours after study inclusion
Acute physiology and chronic health evaluation (APACHE) Ⅱ score
Lasso di tempo: 0 hour after study inclusion

0-67, higher scores correspond to more severe disease and a higher risk of death
0 hour after study inclusion
Acute physiology and chronic health evaluation (APACHE) Ⅱ score
Lasso di tempo: 24 hours after study inclusion

0-67, higher scores correspond to more severe disease and a higher risk of death
24 hours after study inclusion
Acute physiology and chronic health evaluation (APACHE) Ⅱ score
Lasso di tempo: 48 hours after study inclusion

0-67, higher scores correspond to more severe disease and a higher risk of death
48 hours after study inclusion
Acute physiology and chronic health evaluation (APACHE) Ⅱ score
Lasso di tempo: 72 hours after study inclusion

0-67, higher scores correspond to more severe disease and a higher risk of death
72 hours after study inclusion
Sequential organ failure assessment (SOFA) score
Lasso di tempo: 0 hour after study inclusion

0-43, higher scores correspond to more severe sepsis
0 hour after study inclusion
Sequential organ failure assessment (SOFA) score
Lasso di tempo: 24 hours after study inclusion

0-43, higher scores correspond to more severe sepsis
24 hours after study inclusion
Sequential organ failure assessment (SOFA) score
Lasso di tempo: 48 hours after study inclusion

0-43, higher scores correspond to more severe sepsis
48 hours after study inclusion
Sequential organ failure assessment (SOFA) score
Lasso di tempo: 72 hours after study inclusion

0-43, higher scores correspond to more severe sepsis
72 hours after study inclusion
Mechanical ventilation time after inclusion
Lasso di tempo: Up to 8 weeks

Patients requiring mechanical ventilation after study inclusion
Up to 8 weeks
Total hospital length of stay
Lasso di tempo: Through study completion, an average of 2 year

Total length of hospital stay
Through study completion, an average of 2 year
Infection complications
Lasso di tempo: Through study completion, an average of 2 year

Pulmonary infection, urinary tract infection, bloodstream infections, etc
Through study completion, an average of 2 year
In-hospital mortality
Lasso di tempo: Through study completion, an average of 2 year

Mortality rates for the entire period of hospitalization
Through study completion, an average of 2 year
90-day readmission rate
Lasso di tempo: Through study completion, an average of 2 year

Percentage of readmission to hospital within 90 days of study inclusion
Through study completion, an average of 2 year
CCL1 expression in alveolar macrophages (0 h)
Lasso di tempo: 0 hour after study inclusion

CCL1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
0 hour after study inclusion
CCL1 expression in alveolar macrophages (24 h)
Lasso di tempo: 24 hours after study inclusion

CCL1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
24 hours after study inclusion
CCL1 expression in alveolar macrophages (72 h)
Lasso di tempo: 72 hours after study inclusion

CCL1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
72 hours after study inclusion
expression of WNT pathway proteins in alveolar macrophages (0 h)
Lasso di tempo: 0 hour after study inclusion

Wnt5a, FZD5, b-catenin, Lef1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
0 hour after study inclusion
expression of WNT pathway proteins in alveolar macrophages (24 h)
Lasso di tempo: 24 hours after study inclusion

Wnt5a, FZD5, b-catenin, Lef1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
24 hours after study inclusion
expression of WNT pathway proteins in alveolar macrophages (72 h)
Lasso di tempo: 72 hours after study inclusion

Wnt5a, FZD5, b-catenin, Lef1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
72 hours after study inclusion

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Investigatori

  • Investigatore principale: Shiying Yuan, PhD, MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

28 luglio 2021

Completamento primario (Effettivo)

1 gennaio 2026

Completamento dello studio (Effettivo)

1 gennaio 2026

Date di iscrizione allo studio

Primo inviato

29 marzo 2021

Primo inviato che soddisfa i criteri di controllo qualità

11 aprile 2021

Primo Inserito (Effettivo)

14 aprile 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 settembre 2026

Ultimo verificato

1 luglio 2025

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • YSY202001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

Six months after the paper was published

Criteri di accesso alla condivisione IPD

The raw data supporting the conclusions of this manuscript will be made available by the authors, without undue reservation, to any qualified researcher.

Tipo di informazioni di supporto alla condivisione IPD

  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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