NCT02449928

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

1.3 years

First QC Date

May 18, 2015

Last Update Submit

May 19, 2015

Conditions

Severe Sepsis With Septic ShockLactate

Keywords

Severe Sepsis with Septic Shock, Lactate

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    28 days after the diagnosis of septic shock

Study Arms (2)

lactate group,

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

control group

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

Interventions

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

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

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

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

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis in patients with septic shock

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Da-Wei Liu, Professor

    Department of Critical Care Medicine, Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

Da-Wei Liu, professor

CONTACT

+86 10 69152305dwliu98@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 20, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 20, 2015

Record last verified: 2015-05