SepsisNCT04155060
The Prognostic Value of Lactate is Different Among Septic Patients
An observational study of Sepsis and Diabetes Mellitus, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Early diagnosis of sepsis and identification of more severe sepsis is important to improve the outcomes .Therefore, reliable markers are required to early identify the high-risk patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sepsis, Diabetes Mellitus
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 1 Apr 2019
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Septic patients were recruited with lactate level obtained, and admission to the intensive care unit (ICU) .
Inclusion Criteria:18 years or older, informed consent signed, admission serum lactate level obtained, and admission to the hospital with sepsis or septic shock diagnosis.
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Exclusion Criteria:congenital metabolic and psychiatric diseases and clinical data deficiency.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prognostic Value of Lactate is Different Among Septic Patients With or Without Diabetes Mellitus
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Early diagnosis of sepsis and identification of more severe sepsis is important to improve the outcomes .Therefore, reliable markers are required to early identify the high-risk patients. Currently, lactate is widely applied as the marker for evaluating the severity of sepsis and for outcome predicting. DM affects lactate balance and raised baseline lactate. The objective of this study was to compare the different prognostic value of admission lactate for sepsis patients with or without DM.
Read the detailed description
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Early diagnosis of sepsis and identification of more severe sepsis is important to improve the outcomes .Therefore, reliable markers are required to early identify the high-risk patients.
Currently, lactate is widely applied as the marker for evaluating the severity of sepsis and for outcome predicting.Nevertheless, the value of lactate for predicting sepsis is still controversial.The reasons for the different cutoff value may be due to the fact that sepsis is a heterogeneous disease which has already been defined by a number of clinical, laboratory and radiologic criteria, rather than specific pathologic findings. Therefore, we hypothesized that the discrepancy clinical value of lactate may be resulted from the heterogeneous feature of sepsis.
DM affects lactate balance and raised baseline lactate. The objective of this study was to compare the different prognostic value of admission lactate for sepsis patients with or without DM.
- Conditions
- Sepsis, Diabetes Mellitus
- Keywords
- hyperlactatemia
- Medical subject headings
- Sepsis, Diabetes Mellitus, Hyperlactatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DM group , non-DM group | Septic patients were divided into the DM group and non-DM group, based on their comorbidity | |
| high lactate group,low lactate group | high lactate group (lactate > 2 mmol/L) and low lactate group (lactate ≤ 2 mmol/L), according to the admission lactate level. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was 28-day mortality
Measured: up to at least 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start1 Apr 2017
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
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 Shanghai Zhongshan HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155060
- Sponsor's protocol ID
- PROMPT
- Status last verified
- Jul 2020
- First submitted
- 5 Nov 2019
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of Lactate is Different Among Septic Patients With or Without Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04155060
- Acronym / sponsor ID
- PROMPT
- Conditions
- Sepsis, Diabetes Mellitus
- Keywords
- hyperlactatemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 7 Nov 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.
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Early diagnosis of sepsis and identification of more severe sepsis is important to improve the outcomes .Therefore, reliable markers are required to early identify the high-risk patients. Currently, lactate is widely applied as the marker for evaluating the severity of sepsis and for outcome predicting. DM affects lactate balance and raised baseline lactate. The objective of this study was to compare the different prognostic value of admission lactate for sepsis patients with or without DM.
Detailed description
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Early diagnosis of sepsis and identification of more severe sepsis is important to improve the outcomes .Therefore, reliable markers are required to early identify the high-risk patients.
Currently, lactate is widely applied as the marker for evaluating the severity of sepsis and for outcome predicting.Nevertheless, the value of lactate for predicting sepsis is still controversial.The reasons for the different cutoff value may be due to the fact that sepsis is a heterogeneous disease which has already been defined by a number of clinical, laboratory and radiologic criteria, rather than specific pathologic findings. Therefore, we hypothesized that the discrepancy clinical value of lactate may be resulted from the heterogeneous feature of sepsis.
DM affects lactate balance and raised baseline lactate. The objective of this study was to compare the different prognostic value of admission lactate for sepsis patients with or without DM.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DM group , non-DM group | – | –Septic patients were divided into the DM group and non-DM group, based on their comorbidity |
| high lactate group,low lactate group | – | –high lactate group (lactate > 2 mmol/L) and low lactate group (lactate ≤ 2 mmol/L), according to the admission lactate level. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Septic patients were recruited with lactate level obtained, and admission to the intensive care unit (ICU) .
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
The primary outcome was 28-day mortality
Time frame: up to at least 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Diabetes Mellitus, run by Shanghai Zhongshan Hospital 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?
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: finished, as of the sponsor's last update on 27 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was 28-day mortality (time frame: up to at least 28 days). 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 27 Jul 2020.