Using Sodium Lactate Ringer's Injection Resuscitate Septic Shock Patients

Not Applicable

• Conditions: Lactate; Severe Sepsis With Septic Shock
• Interventions: Drug: sodium lactate Ringer's injection(Baxter, ShangHai, China); Drug: Compound Sodium Chloride Injection (CR Double-Crane, Beijing, China)

• Registration Number: NCT02449928
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

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 Timeline

• Status Verified: 2015-05
• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-19
• Last Update Submitted: 2015-05-19
• Study First Posted: 2015-05-20
• Last Update Posted: 2015-05-20
• Study Start: 2015-09
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lactate group,	sodium lactate Ringer's injection(Baxter, ShangHai, China)	-
control group	Compound Sodium Chloride Injection (CR Double-Crane, Beijing, China)	-

Primary Outcome Measures

Name	Time	Method
28-day mortality	28 days after the diagnosis of septic shock