Lactated Ringer's and PlasmaLyte in Critically Ill Adults | NCT03813563

Studies
Lactated Ringer's and PlasmaLyte in Critically Ill Adults

NCT03813563

Sponsor

West China Hospital

Status

Unknown status

Last Update Posted

Jan 24, 2019Actual

Enrollment

12,000Estimated

Phase

Not provided

Conditions

Critical Illness

Interventions

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 13, 2018Actual

Primary Completion Date

Dec 15, 2018Actual

Completion Date

Feb 2019Estimated

First Submitted Date

Jan 19, 2019

First Submission Date that Met QC Criteria

Jan 19, 2019

First Posted Date

Jan 23, 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

Jan 22, 2019

Last Update Posted Date

Jan 24, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Description Module

Brief Summary

In recent years, there has been a large amount of literature reports that normal saline can increase the incidence of renal injury in critically ill patients compared with balanced salt solution.However, no studies have compared the effects of different types of balanced salt solutions on the incidence of renal injury.

Detailed Description

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

12,000Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Mix group	Patients who used two balanced salt solutions during icu stay	Drug: RL Drug: PLA
RL group	Patients who have only used lactated Ringer's during icu stay	Drug: RL
PLA group	Patients who have only used PlasmaLyte during icu stay	Drug: PLA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RL	Drug	lactated Ringer's	Mix group RL group
PLA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of acute kidney injury	The incidence of acute kidney injury	from admission to 28 days

Secondary Outcomes

Measure	Description	Time Frame
the incidency of CRRT events	the incidency of CRRT events	from admission to 28 days
the ventilation free days	the ventilation free days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients admitted to ICU

Exclusion Criteria:

Patients <18 year old when admission
Patients who stay less than 24 hours in ICU
Patients who do not sufficient data for further analysis
Readmission patients during the study period

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

All ICU admissions

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Critical care medicine of West China Hospital		Chengdu	Sichuan	610041	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided