Sepsis Clinical Trial
— sepsisOfficial title:
A Prospective, Single-center Study of Temperature Gradients for Sepsis Severity and Fluid Resuscitation
Verified date | August 2019 |
Source | Nanfang Hospital of Southern Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The assessment and treatment of Septic Shock (SS) is a thorny issue in current care. Fluid resuscitation is one of the key measures for SS treatment. Current fluid resuscitation is dominated by empirical treatment or early target-directed therapy. The former has a clear goal of recovery, and the latter is complicated to implement and has many complications. It is known that patients with SS due to insufficient tissue perfusion, the distribution of blood flow in the peripheral center to the center, may lead to an increase in the central-peripheral-room temperature difference, suggesting that this index has potential value for direction of fluid resuscitation. This study intends to measure the severity of SS and efficacy of fluid resuscitation by measuring the "central-peripheral-room temperature" gradient of patients as well as comparing temperature gradient with hemodynamic indexes (PICCO) and indexes of ultrasound capacity assessment, providing more convenient indicators for sepsis and fluid resuscitation assessment.
Status | Recruiting |
Enrollment | 205 |
Est. completion date | September 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Older than 17 years old. - Patients with sepsis or septic shock who meet the diagnostic criteria for sepsis 3.0 and who are routinely treated according to «Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016». - Get informed consent within 2 hours. Exclusion Criteria: - Age <18 years old. - A confirmed pregnancy or urine pregnancy test is positive. - Patients with septic shock at low temperature (central body temperature <35 °C). - The informed consent of the legal representative of the subject was not obtained. - Known liver disease affecting peripheral perfusion assessment, such as vascular occlusive vasculitis, multiple arteritis, and Raynaud's disease. - Any disease that restricts the use of fluid resuscitation, such as: heart failure, major cardiac surgery, post-cardiopulmonary resuscitation, severe heart disease. |
Country | Name | City | State |
---|---|---|---|
China | NanFang hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Nanfang Hospital of Southern Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 28-day mortality | Rate of all-caused mortality at 28 days | three years | |
Secondary | ICU Length of stay | Days of participants stay in the intensive care unit (ICU) | three years | |
Secondary | Hospital Length of stay | Days of participants stay in hospital | three years |
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