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Using Sodium Lactate Ringer's Injection Resuscitate Septic Shock Patients

Primary Purpose

Severe Sepsis With Septic Shock, Lactate

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

sodium lactate Ringer's injection(Baxter, ShangHai, China)

Compound Sodium Chloride Injection (CR Double-Crane, Beijing, China)

About this trial

This is an interventional treatment trial for Severe Sepsis With Septic Shock focused on measuring Severe Sepsis with Septic Shock, Lactate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

lactate group,

control group

Arm Description

Outcomes

Primary Outcome Measures

28-day mortality

Secondary Outcome Measures

Full Information

NCT ID

NCT02449928

First Posted

May 18, 2015

Last Updated

May 19, 2015

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02449928

Brief Title

Using Sodium Lactate Ringer's Injection Resuscitate Septic Shock Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Sepsis With Septic Shock, Lactate

Keywords

Severe Sepsis with Septic Shock, Lactate

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

8. Arms, Groups, and Interventions

Arm Title

lactate group,

Arm Type

Active Comparator

Arm Title

control group

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

sodium lactate Ringer's injection(Baxter, ShangHai, China)

Intervention Description

use sodium lactate Ringer's injection to resuscitate the septic shock patients(lactate group)

Intervention Type

Drug

Intervention Name(s)

Compound Sodium Chloride Injection (CR Double-Crane, Beijing, China)

Intervention Description

use Compound Sodium Chloride injection to resuscitate the septic shock patients(control group)

Primary Outcome Measure Information:

Title

28-day mortality

Time Frame

28 days after the diagnosis of septic shock

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Da-Wei Liu, professor

Phone

+86 10 69152305

dwliu98@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Da-Wei Liu, Professor

Organizational Affiliation

Department of Critical Care Medicine, Peking Union Medical College Hospital

Official's Role

Study Chair

12. IPD Sharing Statement

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Using Sodium Lactate Ringer's Injection Resuscitate Septic Shock Patients

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