SepsisNCT03256461
Lactate Clearance Goal-directed Therapy in Sepsis
A study testing Lactate clearance 10% target group, Lactate clearance 20% target group and Standard EGDT group in people with Sepsis, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Serum lactate level is depended on the balance between lactate production and clearance. It is seen as a sensitive indicator reflecting not only the low systemic perfusion but microcirculatory dysfunction which cause global or regional tissue hypoxia (as a result of impaired mitochondrial oxidation). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Lactate clearance 10% target group, Lactate clearance 20% target group and Standard EGDT group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,128 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2017to Dec 2021
- Phase
- Interventional
- 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
Who may be able to join
- Older than 17 years old.
- Primary diagnosis is sepsis, means being confirmed or suspected infection while have at least 2 points of quickSOFA(qSOFA).
- Be transferred to intensive care unit (ICU) for the first time during this hospitalization.
- Elevated lactate ≥3.0mmol/L.
Who cannot join
- Acute hemorrhage uncontrolled.
- Pregnancy.
- Known liver disease - Child-Pugh classes C, acute hepatic failure, severe hepatopathy accompany with prominent portal hypertension.
- Known being in an immunosuppressive state:
- Suffering from any disease that is unrelated with sepsis that severely inhibits the immune to infection, such as: active hematological or lymphoma malignancy, or during immunosuppressive therapy, such as chemotherapy or radiotherapy.
- Known human immunodeficiency virus (HIV) serology positive.
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- Known chronic kidney disease.
- Suffering from any disease that affects lactate kinetics, such as mitochondrial encephalopathy, congenital hyperlipidemia, Wernicke encephalopathy, etc. Or other probable cause of hyperlactatemia.
- Took any drugs that affect lactate kinetics within the effective time window, such as taking metformin or phenylephrine within 1 week.
- Suffering from any disease that restricts resuscitation, such as heart failure, cardiac surgery, severe heart disease etc, or suffered from a cardio-pulmonary resuscitation,.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
NanFang hospital
Guangzhou, Guangdong, 510515
Zhongqing Chen, Ph.D, +86 20 6164 1886, 13503049103@163.com
Yaoyuan Zhang, Master, m18620660446@163.com
About this study
Official title: Multi-center Clinical Trial of Lactate Clearance Goal-directed Fluid Resuscitation in Patients With Sepsis
Serum lactate level is depended on the balance between lactate production and clearance. It is seen as a sensitive indicator reflecting not only the low systemic perfusion but microcirculatory dysfunction which cause global or regional tissue hypoxia (as a result of impaired mitochondrial oxidation). 2016 Surviving Sepsis Campaign guideline stated "We suggest guiding resuscitation to normalize lactate in patients with elevated lactate levels as a marker of tissue hypoperfusion", with weak recommendation and low quality of evidence. Several trials which evaluated the resuscitation strategy included lactate clearance as a target while based on 2.0 diagnostic criteria for sepsis, finally showed conflicting results. The aim of this study is to explore the feasibility of lactate clearance guide resuscitation in sepsis that defined by The Third International Consensus Definitions for Sepsis and Septic shock through multi-center, central-randomization clinical trial.
Read the detailed description
Sepsis remains a great challenge for clinicians, early goal-directed therapy(EGDT), referring to a number of target-achieving indicators including systemic central venous oxygen saturation(ScvO2) after initial fluid resuscitation within 6 hours, has been one of the main treatment for sepsis. ScvO2 is the only indicator that reflects tissue oxygen metabolism. However, there're studies confirmed that ScvO2 oriented EGDT cannot reduce the mortality of sepsis. So it is important to find out a more effective indicator. Lactic acid is a product of anaerobic metabolism of the body, lactate clearance has been found to effectively predict the prognosis of sepsis. Few studies have shown that lactate clearance oriented fluid resuscitation can be of benefit in patients with sepsis. Nevertheless, whether lactate clearance could be combined with sepsis Bundle as a new marker to improve the prognosis remains a problem. The objective of this study is to discuss the feasibility of lactate clearance oriented sepsis treatment through multi-center clinical trial.
- Conditions
- Sepsis
- Being tested
- Lactate clearance 10% target group, Lactate clearance 20% target group, Standard EGDT group
- Keywords
- sepsis, lactate clearance, protocolized resuscitation
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactate clearance 10% target groupBehavioural
Also called Lac% 10% group
Participants receive the protocolized resuscitation to achieve the goal of 10-percent lactate clearance every two hours within the initial six hours of treatment.
Lactate clearance 20% target groupBehavioural
Also called Lac% 20% group
Participants receive the protocolized resuscitation to achieve the goal of 20-percent lactate clearance every two hours within the initial six hours of treatment.
Standard EGDT groupBehavioural
Also called EGDT group
Participants receive the strategy of early goal-directed treatment of sepsis fluid resuscitation.
| Study group | Role | What they receive |
|---|---|---|
| Lactate clearance 10% target group | Experimental | Lactate clearance falls by 10-percent every two hours. Receives: Behavioral: Lactate clearance 10% target group |
| Lactate clearance 20% target group | Experimental | Lactate clearance falls by 20-percent every two hours. Receives: Behavioral: Lactate clearance 20% target group |
| Standard EGDT group | Placebo comparator | Refer to the Surviving Sepsis Campaign(SSC) 2012 sepsis guidelines within 6 h liquid resuscitation. Receives: Behavioral: Standard EGDT group |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-d mortality
All-cause mortality at 28 days
Measured: Four years
Secondary outcomes (8)
ICU Length of stay
Length of stay in the intensive care unit (ICU)
Measured: Four years
Hospital Length of stay
Length of stay in hospital
Measured: Four years
90-d mortality
All-cause mortality at 90 days
Measured: Four years
In-hospital mortality
All-cause mortality during hospitalization
Measured: Four years
In-ICU mortality
All-cause mortality during ICU stay
Measured: Four years
Administered treatments
Administered treatments included: crystalloid volume, vasopressor administered, dobutamine, red blood cell(RBC) transfusion, mechanical ventilation, renal-replacement therapy
Measured: Four years
SOFA at 24h
Sequential Organ Failure Assessment(SOFA) at 24 hours
Measured: Four years
Adverse events
Proportion of patients reporting treatment-emergent adverse events
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start21 Aug 2017 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial is a prospective, multicenter, single-blind, parallel-group, central-randomized, controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Zhongqing, Ph.D, Study chair, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256461
- Sponsor's protocol ID
- LCGRIS-01
- Status last verified
- Aug 2017
- First submitted
- 7 Aug 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Clinical Trial of Lactate Clearance Goal-directed Fluid Resuscitation in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT03256461
- Acronym / sponsor ID
- LCGRIS-01
- Conditions
- Sepsis
- Keywords
- sepsis, lactate clearance, protocolized resuscitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,128 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 21 Aug 2017 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 22 Aug 2017 (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.
Serum lactate level is depended on the balance between lactate production and clearance. It is seen as a sensitive indicator reflecting not only the low systemic perfusion but microcirculatory dysfunction which cause global or regional tissue hypoxia (as a result of impaired mitochondrial oxidation). 2016 Surviving Sepsis Campaign guideline stated "We suggest guiding resuscitation to normalize lactate in patients with elevated lactate levels as a marker of tissue hypoperfusion", with weak recommendation and low quality of evidence. Several trials which evaluated the resuscitation strategy included lactate clearance as a target while based on 2.0 diagnostic criteria for sepsis, finally showed conflicting results. The aim of this study is to explore the feasibility of lactate clearance guide resuscitation in sepsis that defined by The Third International Consensus Definitions for Sepsis and Septic shock through multi-center, central-randomization clinical trial.
Detailed description
Sepsis remains a great challenge for clinicians, early goal-directed therapy(EGDT), referring to a number of target-achieving indicators including systemic central venous oxygen saturation(ScvO2) after initial fluid resuscitation within 6 hours, has been one of the main treatment for sepsis. ScvO2 is the only indicator that reflects tissue oxygen metabolism. However, there're studies confirmed that ScvO2 oriented EGDT cannot reduce the mortality of sepsis. So it is important to find out a more effective indicator. Lactic acid is a product of anaerobic metabolism of the body, lactate clearance has been found to effectively predict the prognosis of sepsis. Few studies have shown that lactate clearance oriented fluid resuscitation can be of benefit in patients with sepsis. Nevertheless, whether lactate clearance could be combined with sepsis Bundle as a new marker to improve the prognosis remains a problem. The objective of this study is to discuss the feasibility of lactate clearance oriented sepsis treatment through multi-center clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This trial is a prospective, multicenter, single-blind, parallel-group, central-randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Lactate clearance 10% target group | Experimental | Behavioral: Lactate clearance 10% target groupLactate clearance falls by 10-percent every two hours. |
| Lactate clearance 20% target group | Experimental | Behavioral: Lactate clearance 20% target groupLactate clearance falls by 20-percent every two hours. |
| Standard EGDT group | Placebo comparator | Behavioral: Standard EGDT groupRefer to the Surviving Sepsis Campaign(SSC) 2012 sepsis guidelines within 6 h liquid resuscitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 17 years old.
- Primary diagnosis is sepsis, means being confirmed or suspected infection while have at least 2 points of quickSOFA(qSOFA).
- Be transferred to intensive care unit (ICU) for the first time during this hospitalization.
- Elevated lactate ≥3.0mmol/L.
Key exclusion criteria (10 listed)
- Acute hemorrhage uncontrolled.
- Pregnancy.
- Known liver disease - Child-Pugh classes C, acute hepatic failure, severe hepatopathy accompany with prominent portal hypertension.
- Known being in an immunosuppressive state:
- Known chronic kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactate clearance 10% target groupAlso: Lac% 10% groupParticipants receive the protocolized resuscitation to achieve the goal of 10-percent lactate clearance every two hours within the initial six hours of treatment. | Behavioural | Lactate clearance 10% target group |
| Lactate clearance 20% target groupAlso: Lac% 20% groupParticipants receive the protocolized resuscitation to achieve the goal of 20-percent lactate clearance every two hours within the initial six hours of treatment. | Behavioural | Lactate clearance 20% target group |
| Standard EGDT groupAlso: EGDT groupParticipants receive the strategy of early goal-directed treatment of sepsis fluid resuscitation. | Behavioural | Standard EGDT group |
Primary outcome
28-d mortality
Time frame: Four years
All-cause mortality at 28 days
8 secondary outcomes
ICU Length of stay
Time frame: Four years
Hospital Length of stay
Time frame: Four years
90-d mortality
Time frame: Four years
In-hospital mortality
Time frame: Four years
In-ICU mortality
Time frame: Four years
Administered treatments
Time frame: Four years
SOFA at 24h
Time frame: Four years
Adverse events
Time frame: Four years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- 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.
Chen Zhongqing, Ph.D study chair
Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactate clearance 10% target group, Lactate clearance 20% target group and Standard EGDT group in people with 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 4 inclusion and 10 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 22 Aug 2017. 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. Some participants in this study may receive a placebo. 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?
Contact Chen Zhongqing, Ph.D (020-61641886, 13503049103@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-d mortality (time frame: Four 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 22 Aug 2017; AzTrials last refreshed its copy on 31 Oct 2026.