SIRSNCT02083198
Effects of IV Chloride Content on Outcomes
An observational study of SIRS and Balanced Fluids, run by Baxter Healthcare Corporation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SIRS, Balanced Fluids, Plasmalyte
- How many people
- 1,558 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 1 Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients with SIRS needing fluid replacement
Who may be able to join
- Adults meeting SIRS criteria receiving at least 500 mL of fluid replacement on day of SIRS.
Who cannot join
- Receipt of starches or other colloids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- SIRS, Balanced Fluids, Plasmalyte
- Keywords
- hyperchloremic acidosis, balanced fluids, plasmalyte
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High Chloride | Patients receiving .9% sodium choride for resuscitation | |
| Low chloride | Patients receiving Plasmalyte for resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Inpatient mortality. Expected Length of inpatient stay is approximately 7 days
Measured: Hospitalization, Expected Length of inpatient stay is approximately 7 days
Secondary outcomes (5)
Length of Stay
Measured: inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
Acute renal failure
Measured: inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
Infections
Measured: inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
dysrhythmias
Measured: inpatient hospitalization, Expected Length of inpatient stay is approximately 7 days
Electrolyte disorders
Measured: inpatient hospitalizationExpected Length of inpatient stay is approximately 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startSep 2013
- Primary completion1 Apr 2014
- Study completion1 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SIRSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,558 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083198
- Sponsor's protocol ID
- Bax-BSP-HiLoCl
- Status last verified
- Jun 2017
- First submitted
- 5 Mar 2014
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Shaw AD, Schermer CR, Lobo DN, Munson SH, Khangulov V, Hayashida DK, Kellum JA. Impact of intravenous fluid composition on outcomes in patients with systemic inflammatory response syndrome. Crit Care. 2015 Sep 12;19(1):334. doi: 10.1186/s13054-015-1045-z.
PubMed 26370823
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of High and Low Chloride Containing IV Fluid Solutions in Patients Undergoing Major Surgery and/or ICU Admission
- ClinicalTrials.gov ID
- NCT02083198
- Acronym / sponsor ID
- Bax-BSP-HiLoCl
- Conditions
- SIRS, Balanced Fluids, Plasmalyte
- Keywords
- hyperchloremic acidosis, balanced fluids, plasmalyte
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,558 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2013 (actual)
- Primary completion
- 1 Apr 2014 (actual)
- Study completion
- 1 Apr 2014 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Chloride | – | –Patients receiving .9% sodium choride for resuscitation |
| Low chloride | – | –Patients receiving Plasmalyte for resuscitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with SIRS needing fluid replacement
Key inclusion criteria (1 listed)
- Adults meeting SIRS criteria receiving at least 500 mL of fluid replacement on day of SIRS.
Key exclusion criteria (1 listed)
- Receipt of starches or other colloids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: Hospitalization, Expected Length of inpatient stay is approximately 7 days
Inpatient mortality. Expected Length of inpatient stay is approximately 7 days
5 secondary outcomes
Length of Stay
Time frame: 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
Infections
Time frame: 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
Electrolyte disorders
Time frame: inpatient hospitalizationExpected Length of inpatient stay is approximately 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Derived from this study: PubMed 26370823Shaw AD, Schermer CR, Lobo DN, Munson SH, Khangulov V, Hayashida DK, Kellum JA. Impact of intravenous fluid composition on outcomes in patients with systemic inflammatory response syndrome. Crit Care. 2015 Sep 12;19(1):334. doi: 10.1186/s13054-015-1045-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SIRS and Balanced Fluids, run by Baxter Healthcare Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Hospitalization, Expected Length of inpatient stay is approximately 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02083198, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017.