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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Zhenzhen Feng, Doctor
- Numéro de téléphone: 15890658268
- E-mail: huxifzz@163.com
Lieux d'étude
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Henan
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Zhengzhou, Henan, Chine, 450000
- First Affiliated Hospital of Henan University of Traditional Chinese Medicine
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Contact:
- Zhenzhen Feng, Doctor
- Numéro de téléphone: 15890658268
- E-mail: huxifzz@163.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur placebo: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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28-Day All-Cause Mortality
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Jiansheng Li, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-Sepsis-RCT
Informations sur les médicaments et les dispositifs, documents d'étude
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