Integrated Medicine for Sepsis: An RCT With Phenotyping (IMSEP-RCT)
Efficacy of Integrated Chinese and Western Medicine for Sepsis With Phenotypic Profiling: A Randomized Controlled Trial
This study aims to evaluate the clinical efficacy and safety of integrated traditional Chinese and Western medicine in the treatment of sepsis, explore its potential value in improving clinical outcomes, and provide high-quality clinical evidence for the integrated management of sepsis.In addition, blood samples will be collected for phenotyping and subsequent transcriptomic, proteomic, and metabolomic analyses.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of integrated traditional Chinese and Western medicine in patients with sepsis. By comparing primary and secondary clinical outcomes between the intervention and control groups, the study aims to assess the effects of integrated treatment on disease improvement and clinical outcomes in patients with sepsis and to provide high-quality evidence for its clinical application.Biospecimen Collection. Fasting venous blood samples will be collected at predefined time points for subsequent transcriptomic, proteomic, and metabolomic analyses.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Zhenzhen Feng, Doctor
- Puhelinnumero: 15890658268
- Sähköposti: huxifzz@163.com
Opiskelupaikat
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Henan
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Zhengzhou, Henan, Kiina, 450000
- First Affiliated Hospital of Henan University of Traditional Chinese Medicine
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Ottaa yhteyttä:
- Zhenzhen Feng, Doctor
- Puhelinnumero: 15890658268
- Sähköposti: huxifzz@163.com
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Age ≥18 years and <80 years.
- Meeting the Sepsis-3.0 definition and diagnostic criteria for sepsis, with a Sequential Organ Failure Assessment (SOFA) score of 2-13.
- Patients with pulmonary infection or bloodstream infection.
- Meeting the diagnostic criteria for one of the following traditional Chinese medicine syndrome patterns: phlegm-heat obstructing the lung syndrome, exuberant heat-toxin syndrome, Yangming bowel excess syndrome, or stasis-toxin obstructing the collaterals syndrome.
- Written informed consent provided by the patient or the patient's legally authorized representative/family member.
Exclusion Criteria:
- Patients with trauma, including fractures, burns, hepatic rupture, splenic rupture, or other major traumatic injuries.
- Pregnant or breastfeeding women.
- Patients with severe underlying diseases, including unresectable malignancies, hematologic diseases, or human immunodeficiency virus (HIV) infection.
- Use of immunosuppressive therapy or receipt of organ transplantation within the previous 3 months.
- Severe hepatic or renal dysfunction, defined as a score ≥3 in the hepatic or renal component of the SOFA score.
- Participation in another interventional drug clinical trial within 1 month prior to enrollment.
- Known allergy or hypersensitivity to any of the study medications.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: Standard Western Medicine Plus Syndrome-Differentiated Chinese Herbal Medicine
Participants will receive standard Western medical treatment for sepsis in combination with syndrome-differentiated Chinese herbal medicine according to the study protocol. |
Participants will receive standard Western medical treatment for sepsis plus syndrome-differentiated Chinese herbal medicine. The herbal formula will be prescribed according to the participant's traditional Chinese medicine syndrome pattern: Qinghua Formula for phlegm-heat obstructing the lung syndrome (including Scutellaria baicalensis, Fritillaria thunbergii, Gardenia jasminoides, and other herbs); Qingjie Formula for exuberant heat-toxin syndrome (including Lonicera japonica, Gardenia jasminoides, Forsythia suspensa, and other herbs); Tonghe Formula for Yangming bowel excess syndrome (including Rheum palmatum, Magnolia officinalis, processed Citrus aurantium, and other herbs); and Jiehua Formula for stasis-toxin obstructing the collaterals syndrome (including Bubalus bubalis Cornu, Lonicera japonica, Forsythia suspensa, and other herbs). |
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Placebo Comparator: Standard Western Medicine Plus Matching Placebo
Participants will receive standard Western medical treatment for sepsis in combination with a matching placebo of the syndrome-differentiated Chinese herbal medicine according to the study protocol. |
Participants will receive standard Western medical treatment for sepsis plus a matching placebo corresponding to the syndrome-differentiated Chinese herbal medicine. The placebo is prepared using 5% of the corresponding herbal formulation and is designed to match the Chinese herbal granules in appearance, weight, color, and odor. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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28-Day All-Cause Mortality
Aikaikkuna: Day 28 after enrollment
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The proportion of participants who die from any cause within 28 days after enrollment. |
Day 28 after enrollment
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Sequential Organ Failure Assessment (SOFA) Score
Aikaikkuna: Baseline (Day 0), Day 7, Day 14, and Day 28 after enrollment
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The Sequential Organ Failure Assessment (SOFA) score will be used to assess dysfunction in six organ systems: respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal function. The total score ranges from 0 to 24, with higher scores indicating more severe organ dysfunction. |
Baseline (Day 0), Day 7, Day 14, and Day 28 after enrollment
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
Aikaikkuna: Baseline (Day 0), Day 7, Day 14, and Day 28 after enrollment
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Disease severity will be assessed using the Acute Physiology and Chronic Health Evaluation II (APACHE II) score. The total score ranges from 0 to 71, with higher scores indicating greater disease severity. |
Baseline (Day 0), Day 7, Day 14, and Day 28 after enrollment
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Length of ICU Stay
Aikaikkuna: From ICU admission through hospital discharge or Day 28, whichever occurs first
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The duration of ICU stay will be calculated in days from ICU admission to the first discharge from the ICU. For participants who are readmitted to the ICU, ICU readmission and the cumulative duration of ICU stay will also be recorded. |
From ICU admission through hospital discharge or Day 28, whichever occurs first
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Ventilator-Free Days Within 28 Days
Aikaikkuna: From enrollment through Day 28
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The number of days during the first 28 days after enrollment that a participant is alive and free from invasive mechanical ventilation will be calculated. |
From enrollment through Day 28
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ICU-Free Days Within 28 Days
Aikaikkuna: From enrollment through Day 28
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The number of days through Day 28 during which a participant is alive and remains outside the ICU after the first ICU discharge will be calculated. |
From enrollment through Day 28
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Time to Sustained Resolution of Fever
Aikaikkuna: From enrollment through Day 28
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The time from enrollment to normalization of body temperature sustained for more than 72 hours will be recorded. A transient reduction in body temperature following administration of antipyretic medication will not be considered sustained resolution of fever. |
From enrollment through Day 28
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Duration of Antimicrobial Therapy
Aikaikkuna: From enrollment through hospital discharge or Day 28, whichever occurs first.
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The cumulative duration of intravenous and/or oral antimicrobial therapy during hospitalization will be recorded in days. |
From enrollment through hospital discharge or Day 28, whichever occurs first.
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Yhteistyökumppanit ja tutkijat
Tutkijat
- Opintojen puheenjohtaja: Jiansheng Li, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2026-Sepsis-RCT
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