Temperature Gradients for Sepsis Severity and Fluid Resuscitation

NCT04068298 | Unknown

• 2 other identifiers: 2018cr047320.6750.18431
• Study Type: observational
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis

Keywords

sepsis; temperature gradient; microcirculation

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  Rate of all-caused mortality at 28 days

  three years

Secondary Outcomes (2)

• ICU Length of stay

  three years

• Hospital Length of stay

  three years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study subjects were patients with sepsis and/or septic shock in the Department of Critical Care Medicine, Southern Hospital from September 2019 to September 2022.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

NanFang hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

CN (1)