Effects of IV Chloride Content on Outcomes

June 20, 2017 updated by: Baxter Healthcare Corporation

A Comparison of High and Low Chloride Containing IV Fluid Solutions in Patients Undergoing Major Surgery and/or ICU Admission

This observational study evaluates the impact of high and low chloride containing IV fluids on administrative and clinical outcomes. The study uses a large electronic health dataset and examines patients receiving fluid replacement and resuscitation. The hypothesis is that high chloride solutions are associated with adverse outcomes as measured by administrative data and by clinical parameters.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1558

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

  • United States
    • Illinois
      • Deerfield, Illinois, United States, 60015
        • Baxter Healthcare

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

adult patients with SIRS needing fluid replacement

Description

Inclusion Criteria:

  • Adults meeting SIRS criteria receiving at least 500 mL of fluid replacement on day of SIRS.

Exclusion Criteria:

  • Receipt of starches or other colloids

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

Cohorts and Interventions

Group / Cohort
High Chloride
Patients receiving .9% sodium choride for resuscitation
Low chloride
Patients receiving Plasmalyte for resuscitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Hospitalization, Expected Length of inpatient stay is approximately 7 days
Inpatient mortality. Expected Length of inpatient stay is approximately 7 days
Hospitalization, Expected Length of inpatient stay is approximately 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of Stay
Time Frame: inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
Acute renal failure
Time Frame: inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
Infections
Time Frame: inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
dysrhythmias
Time Frame: inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
Electrolyte disorders
Time Frame: inpatient hospitalizationExpected Length of inpatient stay is approximately 7 days
inpatient hospitalizationExpected Length of inpatient stay is approximately 7 days

Other Outcome Measures

Outcome Measure
Time Frame
readmission
Time Frame: 30, 60 and 90 day
30, 60 and 90 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 10, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Actual)

June 21, 2017

Last Update Submitted That Met QC Criteria

June 20, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Bax-BSP-HiLoCl

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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Locations

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