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Electroacupuncture Modulates SPMs Metabolism and Respiratory Symptoms in Patients With Sepsis Complicating ARDS 70

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Die klinische Studie NCT06006325 ist eine interventionsstudie zur Untersuchung von Sepsis, Akutes Atemnotsyndrom und hat den Status offene rekrutierung. Die Studie startete am 20. August 2023 und soll 70 Teilnehmer aufnehmen. Durchgeführt von Tianjin Nankai Hospital ist der Abschluss für 2. Oktober 2024 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 26. März 2024 aktualisiert.
Kurzbeschreibung
In this interventional clinical trial, researchers will administer electroacupuncture versus sham electroacupuncture to sepsis patients with ARDS and collect objective outcome measures. The study will be divided into 2 groups. The EA group will receive electroacupuncture and the SHAM-EA group will receive sham electroacupuncture. The purpose of this study is to investigate the effect of electroacupuncture on the synt...Mehr anzeigen
Offizieller Titel

Electroacupuncture Modulates the Metabolism of SPMs and Ameliorates Respiratory Symptoms and Inflammation in Patients With Sepsis Complicating ARDS

Erkrankungen
SepsisAkutes Atemnotsyndrom
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • NKYY_YXKT_IRB_2022_023_01
NCT-Nummer
NCT06006325
Studienbeginn (tatsächlich)
2023-08-20
Zuletzt aktualisiert
2024-03-26
Studienende (vorauss.)
2024-10-02
Geplante Rekrutierung
70
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellElectroacupuncture (EA)
The acupoints were "Deqi", and the electroacupuncture stimulator was connected and energized.
electroacupuncture treatment
Patients received acupuncture on both sides of the Zusanli (ST36) acupuncture points, and after "Deqi ", the needle was connected to an electro-acupuncture device (Hwato, Suzhou Medical ). The EA stimulation lasted for 30 min.
Schein-VergleichspräparatSham electroacupuncture (SHAM-EA)
No "Deqi" operation was performed on non-acupuncture points, and the electroacupuncture stimulator was connected and not energized.
sham electroacupuncture treatment
The participants in the SHAM-EA group performed shallow punctures at the bilateral non-acupuncture points, did not perform the "Deqi" operation, and were connected to the electroacupuncture stimulator but not energized.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Serum levels of Lipoxin A4 (LXA4)
Serum levels of LXA4 were measured in post-intervention patients and levels were compared to Day 0.
Up to 7 days
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
LXA4 levels in BALF
LXA4 levels were measured in the BALF of patients after the intervention and the levels were compared to day 0.
Up to 7 days
Ventilation-free days
The number of days the patient was alive and free of mechanical ventilation (MV)
Up to 28 days
Oxygenation index
The ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage).
Up to 7 days
Ventilator-provided positive end-expiratory pressure (PEEP)
Ventilator parameter
Up to 7 days
plateau pressure
Ventilator parameter
Up to 7 days
tidal volume
Ventilator parameter
Up to 7 days
Inflammation biomarkers Inflammation levels
Procalcitonin (PCT), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6)
Up to 7 days
Sequential Organ-Failure Assessment (SOFA) score
The SOFA score is used to assess the severity and prognosis of sepsis.SOFA was based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction.
Up to 7 days
Rate of electroacupuncture-related adverse events
Rate of electroacupuncture-related adverse events
Up to 28 days
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  1. Males or females over the age of 18;
  2. Diagnosis meets SPESIS 3 criteria for sepsis;
  3. The diagnosis meets the Berlin diagnostic criteria for ARDS;
  4. ARDS was diagnosed within 48h;
  5. Capable of understanding the purpose and risk of the study;
  6. Patients or proxy must give written informed consent before any assessment is performed.

  1. ARDS was diagnosed 48h later;
  2. Pregnancy, lactation or perinatal period;
  3. malignant tumor;
  4. Severe liver failure or kidney failure;
  5. Predicted mortality risk of patients within 24h>80%;
  6. Severe end-stage lung disease;
  7. ECMO patients are undergoing implementation;
  8. HIV seropositive or Syphilis seropositive;
  9. Any clinical-relevant condition that might affect study participation and/or study results;
  10. Participation in any other intervention trial;
  11. Unwillingness or inability to following the study protocol in the investigators opinion.
Tianjin Nankai Hospital logoTianjin Nankai Hospital
Verantwortliche Partei
Jianbo Yu, Hauptprüfer, Prof., Tianjin Nankai Hospital
Zentrale Studienkontakte
Kontakt: Jianbo Yu, MD, +8615344422323, [email protected]
1 Studienstandorte in 1 Ländern

Tianjin Municipality

Tianjin Nankai Hospital, Tianjin, Tianjin Municipality, 300000, China
Shuan Dong, Professor, Kontakt, （022）27435008, [email protected]
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