Effects of IV Chloride Content on Outcomes

SIRS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083198
• Other study ID #: Bax-BSP-HiLoCl
• Status: Completed
• Phase: N/A
• First received: March 5, 2014
• Last updated: June 20, 2017
• Start date: September 2013
• Est. completion date: April 1, 2014

Study information

• Verified date: June 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1558
• Est. completion date: April 1, 2014
• Est. primary completion date: April 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Balanced Fluids
• Plasmalyte
• SIRS

Locations

Country	Name	City	State
United States	Baxter Healthcare	Deerfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	readmission		30, 60 and 90 day
Primary	Mortality	Inpatient mortality. Expected Length of inpatient stay is approximately 7 days	Hospitalization, Expected Length of inpatient stay is approximately 7 days
Secondary	Length of Stay		inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
Secondary	Acute renal failure		inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
Secondary	Infections		inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
Secondary	dysrhythmias		inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
Secondary	Electrolyte disorders		inpatient hospitalizationExpected Length of inpatient stay is approximately 7 days