Using Sodium Lactate Ringer's Injection Resuscitate Septic Shock Patients

May 19, 2015 updated by: Peking Union Medical College Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Da-Wei Liu, Professor, Department of Critical Care Medicine, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 19, 2015

First Posted (Estimate)

May 20, 2015

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PekingUMCH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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