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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Zhenzhen Feng, Doctor
- Telefonní číslo: 15890658268
- E-mail: huxifzz@163.com
Studijní místa
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Henan
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Zhengzhou, Henan, Čína, 450000
- First Affiliated Hospital of Henan University of Traditional Chinese Medicine
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Kontakt:
- Zhenzhen Feng, Doctor
- Telefonní číslo: 15890658268
- E-mail: huxifzz@163.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Komparátor placeba: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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28-Day All-Cause Mortality
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Jiansheng Li, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026-Sepsis-RCT
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