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Effect of Cumulative Chloride Dose on Development of Acute Kidney Injury in Critically Ill Children

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ClinicalTrials.gov Identifier: NCT02188602
Recruitment Status : Unknown
Verified July 2014 by Stanford University.
Recruitment status was:  Active, not recruiting
First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
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.

Condition or disease
Acute Kidney Injury

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 Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Investigation of Chloride Dosing and Its Effect on Acute Kidney Injury
Study Start Date : July 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

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 Dose
Patients receiving high dosing of chloride
Low Chloride Dose
Patients receiving low dosing of chloride


Outcome Measures
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Primary Outcome Measures :
  1. Acute Kidney Injury [ Time Frame: 7 days ]
    or sooner if death or discharged


Secondary Outcome Measures :
  1. PICU length of stay [ Time Frame: 7 days ]
  2. Hospital length of stay [ Time Frame: 7 days ]
  3. Number of ventilator days [ Time Frame: 7 days ]
  4. Mortality [ Time Frame: 7 days ]

Eligibility Criteria
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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.
Contacts and Locations
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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): NCT02188602


Locations
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United States, California
Lucile Packard Children's Hospital
Palo alto, California, United States, 94303
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Weiwen V Shih, MD Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02188602    
Other Study ID Numbers: 27752
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases