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

Status

Unknown

Conditions

Intervention / Treatment

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

  • China
    • 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
Drug: RL
lactated Ringer's
Drug: PLA
PlasmaLyte
RL group
Patients who have only used lactated Ringer's during icu stay
Drug: RL
lactated Ringer's
PLA group
Patients who have only used PlasmaLyte during icu stay
Drug: PLA
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

West China Hospital

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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