- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02188602
Effect of Cumulative Chloride Dose on Development of Acute Kidney Injury in Critically Ill Children
August 17, 2022 updated by: Stanford University
Retrospective Investigation of Chloride Dosing and Its Effect on Acute Kidney Injury
The investigators would like to investigate the effect of chloride dosing on the development of acute kidney injury in critically ill patients.
The investigators hypothesis is that administering intravenous fluids with higher chloride content are more likely to lead to acute kidney injury.
Study Overview
Status
Withdrawn
Conditions
Detailed Description
Retrospective chart review from 2008-2012 evaluating chloride dosing and serum chloride levels and their effects on acute kidney injury in the pediatric ICU.
Patients will be included for the first seven days of their PICU stay.
Study Type
Observational
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
-
-
California
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Palo Alto, California, United States, 94303
- Lucile Packard Children's Hospital
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-
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
1 month to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children < 18 yo admitted to the Pediatric Intensive Care Unit at Lucile Packard Children's Hospital with admitting diagnosis of sepsis, respiratory failure, or liver failure
Description
Inclusion Criteria:
- age less than 18 years
- PICU admitting diagnosis of sepsis, respiratory failure, or hepatic failure.
Exclusion Criteria:
- hyponatremia or hypernatremia at PICU admission
- preexisting diagnosis of End-stage renal disease or renal transplant
- presence of neurologic comorbidities.
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 Dose
Patients receiving high dosing of chloride
|
Low Chloride Dose
Patients receiving low dosing of chloride
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Kidney Injury
Time Frame: 7 days
|
or sooner if death or discharged
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: 7 days
|
7 days
|
PICU length of stay
Time Frame: 7 days
|
7 days
|
Hospital length of stay
Time Frame: 7 days
|
7 days
|
Number of ventilator days
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Weiwen V Shih, MD, Stanford University
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
July 1, 2013
Primary Completion (Anticipated)
June 1, 2015
Study Completion (Anticipated)
June 1, 2015
Study Registration Dates
First Submitted
July 19, 2013
First Submitted That Met QC Criteria
July 10, 2014
First Posted (Estimate)
July 11, 2014
Study Record Updates
Last Update Posted (Actual)
August 22, 2022
Last Update Submitted That Met QC Criteria
August 17, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27752
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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