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Trial record 1 of 1 for:    NCT02083198
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Effects of IV Chloride Content on Outcomes

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ClinicalTrials.gov Identifier: NCT02083198
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Study Description
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Brief Summary:
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.

Condition or disease
SIRS Balanced Fluids Plasmalyte

Study Design
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Study Type : Observational
Actual Enrollment : 1558 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Comparison of High and Low Chloride Containing IV Fluid Solutions in Patients Undergoing Major Surgery and/or ICU Admission
Actual Study Start Date : September 2013
Actual Primary Completion Date : April 1, 2014
Actual Study Completion Date : April 1, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

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


Outcome Measures
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Primary Outcome Measures :
  1. Mortality [ Time Frame: Hospitalization, Expected Length of inpatient stay is approximately 7 days ]
    Inpatient mortality. Expected Length of inpatient stay is approximately 7 days


Secondary Outcome Measures :
  1. Length of Stay [ Time Frame: inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days ]
  2. Acute renal failure [ Time Frame: inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days ]
  3. Infections [ Time Frame: inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days ]
  4. dysrhythmias [ Time Frame: inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days ]
  5. Electrolyte disorders [ Time Frame: inpatient hospitalizationExpected Length of inpatient stay is approximately 7 days ]

Other Outcome Measures:
  1. readmission [ Time Frame: 30, 60 and 90 day ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult patients with SIRS needing fluid replacement
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083198


Locations
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United States, Illinois
Baxter Healthcare
Deerfield, Illinois, United States, 60015
Sponsors and Collaborators
Baxter Healthcare Corporation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT02083198    
Other Study ID Numbers: Bax-BSP-HiLoCl
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Keywords provided by Baxter Healthcare Corporation:
hyperchloremic acidosis
balanced fluids
plasmalyte