ClinicalTrials.gg
Status unknownNCT02449928Updated May 20, 2015

Using Sodium Lactate Ringer's Injection Resuscitate Septic Shock Patients

An interventional study of sodium lactate Ringer's injection(Baxter, ShangHai, China) and Compound Sodium Chloride Injection (CR Double-Crane, Beijing, China) in Severe Sepsis With Septic Shock and Lactate, sponsored by Peking Union Medical College Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-20.

Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Severe Sepsis With Septic Shock
  • Lactate

Keywords

  • Severe Sepsis with Septic Shock, Lactate
03

In context

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 473 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • diagnosis in patients with septic shock

Exclusion criteria

Exclusion Criteria:

  • pregnant women and nursing mothers
  • severe liver failure with child class C
  • using Linezolid
  • pheochromocytoma
  • hematologic malignancy
  • using epinephrine
  • during CVVH treatment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

Study arms

  • Active comparator
    lactate group,

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

  • Active comparator
    control group

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

Interventions

  • Drugsodium lactate Ringer's injection(Baxter, ShangHai, China)

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

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

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

06

What researchers measure

Primary outcomes

  1. 28-day mortality

    Time frame: 28 days after the diagnosis of septic shock

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2015, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 18, 2015
First posted
May 20, 2015
Start
Sep 2015
Primary completionEst.
Dec 2016
CompletionEst.
Dec 2016
Last update
May 20, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02449928
Responsible party
Sponsor
First posted
May 20, 2015
Start date
Sep 2015
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
May 20, 2015

Study contacts

Da-Wei Liu, professor
Contact
dwliu98@163.com
+86 10 69152305
Da-Wei Liu, Professor
study chair · Department of Critical Care Medicine, Peking Union Medical College Hospital
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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