Early Lactate Clearance Rate in Sepsis | NCT04192279

Studies
Early Lactate Clearance Rate in Sepsis

NCT04192279

Sponsor

The Second Hospital of Hebei Medical University

Status

Unknown status

Last Update Posted

Dec 10, 2019Actual

Enrollment

220Estimated

Phase

Not provided

Conditions

Early Lactate Clearance

Interventions

lactate clearance

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Jan 31, 2020Estimated

Completion Date

Feb 15, 2020Estimated

First Submitted Date

Dec 4, 2019

First Submission Date that Met QC Criteria

Dec 9, 2019

First Posted Date

Dec 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2019

Last Update Posted Date

Dec 10, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fei Tong, Director, The Second Hospital of Hebei Medical UniversityPrincipal Investigator

Lead Sponsor

The Second Hospital of Hebei Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

220Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lactate group		Lactate early guide resuscitation	Diagnostic Test: lactate clearance
control group		early guide resuscitation without lactate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lactate clearance	Diagnostic Test	Lactate clearance rate was monitored within 6 hours after admission	lactate group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In-hospital 60days mortality	In-hospital up to 60 days mortality of sepsis	In-hospital 60 days
ICU mortality	ICU up to 30 days mortality of sepsis	up to 30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients whose blood lactate level reached or exceeded 2.0 mEq / L

Exclusion Criteria:

Incomplete clinical data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with severe sepsis or septic shock were recruited from Emergency ICU of the second hospital of Hebei Medical University.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fei Tong, Dr.	Contact	+8615803210603		tongfei168@163.com
Jiangqing Xu, Dr.	Contact	+8615732193221		jq745790350@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Hospital of Hebei Medical University	Recruiting	Shijiazhuang	Hebei	050000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

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Browse Branches

Not provided