Using Sodium Lactate Ringer's Injection Resuscitate Septic Shock Patients

Lactate Clinical Trial

Official title:

Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences,

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02449928
• Other study ID #: PekingUMCH
• Status: Not yet recruiting
• Phase: N/A
• First received: May 18, 2015
• Last updated: May 19, 2015
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2015
• Source: Peking Union Medical College Hospital
• Contact: Da-Wei Liu, professor
• Phone: +86 10 69152305
• Email: dwliu98[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lactate
• Severe Sepsis With Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• sodium lactate Ringer's injection(Baxter, ShangHai, China)
use sodium lactate Ringer's injection to resuscitate the septic shock patients(lactate group)
• Compound Sodium Chloride Injection (CR Double-Crane, Beijing, China)
use Compound Sodium Chloride injection to resuscitate the septic shock patients(control group)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality		28 days after the diagnosis of septic shock	No