SepsissepsisNCT04068298
Temperature Gradients for Sepsis Severity and Fluid Resuscitation
An observational study of Sepsis, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 205 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
NanFang hospital
Guangzhou, Guangdong, 510515
Zhongqing Chen, Ph.D, 020-61641886, 13503049103@163.com
Lulan Li, Master, 020-61641884, 13631309571@163.com
About this study
Official title: A Prospective, Single-center Study of Temperature Gradients for Sepsis Severity and Fluid Resuscitation
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.
Read the 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.
- Conditions
- Sepsis
- Keywords
- sepsis, temperature gradient, microcirculation
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Rate of all-caused mortality at 28 days
Measured: three years
Secondary outcomes (2)
ICU Length of stay
Days of participants stay in the intensive care unit (ICU)
Measured: three years
Hospital Length of stay
Days of participants stay in hospital
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongqing Chen, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068298
- Sponsor's protocol ID
- 2018cr047
- Other IDs
- 320.6750.18431
- Acronym
- sepsis
- Status last verified
- Aug 2019
- First submitted
- 22 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center Study of Temperature Gradients for Sepsis Severity and Fluid Resuscitation
- ClinicalTrials.gov ID
- NCT04068298
- Acronym / sponsor ID
- sepsis / 2018cr047
- Conditions
- Sepsis
- Keywords
- sepsis, temperature gradient, microcirculation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
28-day mortality
Time frame: three years
Rate of all-caused mortality at 28 days
2 secondary outcomes
ICU Length of stay
Time frame: three years
Hospital Length of stay
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.