Severe Sepsis With Septic ShockNCT02449928
Using Sodium Lactate Ringer's Injection Resuscitate Septic Shock Patients
A study testing sodium lactate Ringer's injection(Baxter, ShangHai, China) and Compound Sodium Chloride Injection (CR Double-Crane, Beijing, China) in people with Severe Sepsis With Septic Shock and Lactate, run by Peking Union Medical College Hospital.
Trial summary
Using sodium lactate Ringer's injection resuscitate septic shock patients and Compared with other solution, in order to make clear whether can improve the prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis With Septic Shock, Lactate
- What is being tested?
- sodium lactate Ringer's injection(Baxter, ShangHai, China) and Compound Sodium Chloride Injection (CR Double-Crane, Beijing, China)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2015to Dec 2016
- 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
- diagnosis in patients with septic shock
Who cannot join
- pregnant women and nursing mothers
- severe liver failure with child class C
- using Linezolid
- pheochromocytoma
- hematologic malignancy
- using epinephrine
- during CVVH treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,
Using sodium lactate Ringer's injection resuscitate septic shock patients and Compared with other solution, in order to make clear whether can improve the prognosis.
Read the detailed description
Experimental evidence repeatedly demonstrated that the shock patients can use substrates other than glucose to sustain increased activity, including lactate.Increased lactate can be the consequence of anaerobic metabolism, i.e., the formation of lactate in the presence of low oxygen. However, emerging evidence demonstrated that in patients with sepsis increased lactate seems predominantly non-hypoxic/ischemic and rather the consequence of increased glycolysis. Utilization of lactate as an alternative fuel may be an adaptive response to maximize energy function and limit substrate reduction.Uptake of exogenous lactate has indeed been demonstrated after traumatic brain injury and acute heart failure in humans.
The investigators assume that administration of supplemental lactate significantly contributes to energy metabolism in septic shock, which can have beneficial help for septic shock resuscitation.
Inclusion criteria:diagnosis in patients with septic shock and age 18 years old or more. Exclusion criteria: pregnant women and nursing mothers, severe liver failure with child class C , use linezolid anti-infection treatment, pheochromocytoma patients, CVVH therapy patients, malignant tumor patients, using epinephrine.
The investigators will use sodium lactate Ringer's injection resuscitate septic shock patients and Compared with other solution, the organ function monitoring include heart, kidney,and brain. Others study endpoints include 28-day mortality,hospitalized mortality.
- Conditions
- Severe Sepsis With Septic Shock, Lactate
- Being tested
- sodium lactate Ringer's injection(Baxter, ShangHai, China), Compound Sodium Chloride Injection (CR Double-Crane, Beijing, China)
- Keywords
- Severe Sepsis with Septic Shock, Lactate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium lactate Ringer's injection(Baxter, ShangHai, China)Drug
use sodium lactate Ringer's injection to resuscitate the septic shock patients(lactate group)
Compound Sodium Chloride Injection (CR Double-Crane, Beijing, China)Drug
use Compound Sodium Chloride injection to resuscitate the septic shock patients(control group)
| Study group | Role | What they receive |
|---|---|---|
| lactate group, | Active comparator | Not described Receives: Drug: sodium lactate Ringer's injection(Baxter, ShangHai, China) |
| control group | Active comparator | Not described Receives: Drug: Compound Sodium Chloride Injection (CR Double-Crane, Beijing, China) |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Measured: 28 days after the diagnosis of septic shock
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Sepsis With Septic ShockStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Da-Wei Liu, Professor, Study chair, Department of Critical Care Medicine, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449928
- Sponsor's protocol ID
- PekingUMCH
- Status last verified
- May 2015
- First submitted
- 18 May 2015
- Last updated
- 20 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,
- ClinicalTrials.gov ID
- NCT02449928
- Acronym / sponsor ID
- PekingUMCH
- Conditions
- Severe Sepsis With Septic Shock, Lactate
- Keywords
- Severe Sepsis with Septic Shock, Lactate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 May 2015 (estimated)
- 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.
Using sodium lactate Ringer's injection resuscitate septic shock patients and Compared with other solution, in order to make clear whether can improve the prognosis.
Detailed description
Experimental evidence repeatedly demonstrated that the shock patients can use substrates other than glucose to sustain increased activity, including lactate.Increased lactate can be the consequence of anaerobic metabolism, i.e., the formation of lactate in the presence of low oxygen. However, emerging evidence demonstrated that in patients with sepsis increased lactate seems predominantly non-hypoxic/ischemic and rather the consequence of increased glycolysis. Utilization of lactate as an alternative fuel may be an adaptive response to maximize energy function and limit substrate reduction.Uptake of exogenous lactate has indeed been demonstrated after traumatic brain injury and acute heart failure in humans.
The investigators assume that administration of supplemental lactate significantly contributes to energy metabolism in septic shock, which can have beneficial help for septic shock resuscitation.
Inclusion criteria:diagnosis in patients with septic shock and age 18 years old or more. Exclusion criteria: pregnant women and nursing mothers, severe liver failure with child class C , use linezolid anti-infection treatment, pheochromocytoma patients, CVVH therapy patients, malignant tumor patients, using epinephrine.
The investigators will use sodium lactate Ringer's injection resuscitate septic shock patients and Compared with other solution, the organ function monitoring include heart, kidney,and brain. Others study endpoints include 28-day mortality,hospitalized mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lactate group, | Active comparator | Drug: sodium lactate Ringer's injection(Baxter, ShangHai, China) |
| control group | Active comparator | Drug: Compound Sodium Chloride Injection (CR Double-Crane, Beijing, China) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis in patients with septic shock
Key exclusion criteria (7 listed)
- pregnant women and nursing mothers
- severe liver failure with child class C
- using Linezolid
- pheochromocytoma
- hematologic malignancy
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 |
|---|---|---|
| sodium lactate Ringer's injection(Baxter, ShangHai, China)use sodium lactate Ringer's injection to resuscitate the septic shock patients(lactate group) | Drug | lactate group, |
| Compound Sodium Chloride Injection (CR Double-Crane, Beijing, China)use Compound Sodium Chloride injection to resuscitate the septic shock patients(control group) | Drug | control group |
Primary outcome
28-day mortality
Time frame: 28 days after the diagnosis of septic shock
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
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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.
Da-Wei Liu, Professor study chair
Department of Critical Care Medicine, Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing sodium lactate Ringer's injection(Baxter, ShangHai, China) and Compound Sodium Chloride Injection (CR Double-Crane, Beijing, China) in people with Severe Sepsis With Septic Shock and Lactate, run by Peking Union Medical College Hospital.
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 1 inclusion and 7 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 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Da-Wei Liu, professor (+86 10 69152305, dwliu98@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: 28 days after the diagnosis of septic shock). 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 20 May 2015.