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Temperature Gradients for Sepsis Severity and Fluid Resuscitation (sepsis)

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ClinicalTrials.gov Identifier: NCT04068298
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Zhongqing Chen, Nanfang Hospital of Southern Medical University

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.

Condition or disease
Sepsis

Detailed Description:
Sepsis remains a great challenge for clinicians. Early and timely fluid resuscitation is the basic measure for the treatment of sepsis. It is important to quickly diagnose the severity of sepsis and evaluate the effects of fluid resuscitation. Existing monitoring methods such as blood pressure, urine volume, blood lactate, central venous oxygen saturation (ScvO2), cardiac output (CO), stroke volume variability (SVV), etc. have certain limitations or invasive disadvantages. Clinically, effective and convenient non-invasive means are needed for monitoring. Present research revealed that microcirculatory dysfunction and tissue hypoperfusion have a very important role in the pathophysiological mechanism of sepsis, and will be associated with severe organ dysfunction, which is closely related to serious adverse prognosis. Importantly, tissue hypoperfusion can cause central and peripheral body temperature changes. Studies have shown that clinical assessment of peripheral skin temperature can identify potential severe organ dysfunction in patients with stable hemodynamics. The latest study found that patients with septic shock have greater central-peripheral body temperature differences than sepsis patients, and the temperature difference between peripheral-room temperature is smaller. That is, the central-peripheral-room temperature gradient changes show a reduction of tissue perfusion, suggesting microcirculatory disorders and organ dysfunction. In addition, the body temperature gradient is simple and non-invasive, and is a bedside indicator that predicts tissue perfusion.

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Study Type : Observational
Estimated Enrollment : 205 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Single-center Study of Temperature Gradients for Sepsis Severity and Fluid Resuscitation
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis




Primary Outcome Measures :
  1. 28-day mortality [ Time Frame: three years ]
    Rate of all-caused mortality at 28 days


Secondary Outcome Measures :
  1. ICU Length of stay [ Time Frame: three years ]
    Days of participants stay in the intensive care unit (ICU)

  2. Hospital Length of stay [ Time Frame: three years ]
    Days of participants stay in hospital



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068298


Locations
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China, Guangdong
NanFang hospital Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Zhongqing Chen, Ph.D    020-61641886    13503049103@163.com   
Contact: Lulan Li, Master    020-61641884    13631309571@163.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
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Responsible Party: Zhongqing Chen, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT04068298    
Other Study ID Numbers: 2018cr047
320.6750.18431 ( Other Grant/Funding Number: Wu Jieping Fund )
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhongqing Chen, Nanfang Hospital of Southern Medical University:
sepsis
temperature gradient
microcirculation
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes