- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03813563
Lactated Ringer's and PlasmaLyte in Critically Ill Adults
January 22, 2019 updated by: Kang Yan, West China Hospital
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.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
12000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Department of Critical care medicine of West China Hospital
-
-
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
Sampling Method
Non-Probability Sample
Study Population
All ICU admissions
Description
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
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Mix group
Patients who used two balanced salt solutions during icu stay
|
lactated Ringer's
PlasmaLyte
|
RL group
Patients who have only used lactated Ringer's during icu stay
|
lactated Ringer's
|
PLA group
Patients who have only used PlasmaLyte during icu stay
|
PlasmaLyte
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of acute kidney injury
Time Frame: from admission to 28 days
|
The incidence of acute kidney injury
|
from admission to 28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the incidency of CRRT events
Time Frame: from admission to 28 days
|
the incidency of CRRT events
|
from admission to 28 days
|
the ventilation free days
Time Frame: from admission to 28 days
|
the ventilation free days
|
from admission to 28 days
|
the vasopressure free days
Time Frame: from admission to 28 days
|
the vasopressure free days
|
from admission to 28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
January 13, 2018
Primary Completion (Actual)
December 15, 2018
Study Completion (Anticipated)
February 1, 2019
Study Registration Dates
First Submitted
January 19, 2019
First Submitted That Met QC Criteria
January 19, 2019
First Posted (Actual)
January 23, 2019
Study Record Updates
Last Update Posted (Actual)
January 24, 2019
Last Update Submitted That Met QC Criteria
January 22, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RL vs Plalyte
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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