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Clinical study on the safety and effectiveness of ozone water enema in adjuvant treatment in patients with sepsis

Clinical study on the safety and effectiveness of ozone water enema in adjuvant treatment in patients with sepsis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052744
Enrollment
Unknown
Registered
2021-11-04
Start date
2021-11-03
Completion date
Unknown
Last updated
2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sepsis

Interventions

Group 1:Water sanitizer enema
Group 2:Physiological saline enema

Sponsors

Dongfang Hospital Affiliated to Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years, no gender limit. 2. The diagnostic criteria for sepsis in the new 2016 SSC guidelines are: infection-induced organ dysfunction, SOFA score (Table 2-1) increased by >= 2 points from baseline, for patients without underlying organ dysfunction, the baseline for SOFA is 0; The diagnostic criteria for septic (septic) shock are: on the basis of a clear diagnosis of sepsis, accompanied by persistent hypotension, and on the basis of adequate blood volume replenishment, vasopressors are still required to maintain mean arterial pressure >= 65 mmHg and serum lactate levels > 2 mmol/L (18 mg/dL). 3. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Massive blood loss, acute bleeding, anemia (Hb = 20mg/day; 11. The investigator evaluates that the patient is unable or unwilling to comply with the requirements of the research protocol; 12. Patients with intestinal obstruction, intestinal perforation, colon cancer and rectal cancer.

Design outcomes

Primary

MeasureTime frame
28-day survival rate;

Secondary

MeasureTime frame
procalcitonin;IL-6;C-reactive protein;TNF-a;lactic acid;IL-8;gut microbiota;

Countries

China

Contacts

Public ContactLiao Lijun
liao@pan-support.cim+86 13817428913

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026