- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02449928
Using Sodium Lactate Ringer's Injection Resuscitate Septic Shock Patients
Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,
Study Overview
Status
Conditions
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 Type
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis in patients with septic shock
Exclusion Criteria:
- pregnant women and nursing mothers
- severe liver failure with child class C
- using Linezolid
- pheochromocytoma
- hematologic malignancy
- using epinephrine
- during CVVH treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: control group
|
use Compound Sodium Chloride injection to resuscitate the septic shock patients(control group)
|
Active Comparator: lactate group,
|
use sodium lactate Ringer's injection to resuscitate the septic shock patients(lactate group)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
28-day mortality
Time Frame: 28 days after the diagnosis of septic shock
|
28 days after the diagnosis of septic shock
|
Collaborators and Investigators
Investigators
- Study Chair: Da-Wei Liu, Professor, Department of Critical Care Medicine, Peking Union Medical College Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PekingUMCH
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