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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

Tracking Information
First Submitted Date July 19, 2013
First Posted Date July 11, 2014
Last Update Posted Date July 11, 2014
Study Start Date July 2013
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 10, 2014)
Acute Kidney Injury [ Time Frame: 7 days ]
or sooner if death or discharged
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 10, 2014)
  • PICU length of stay [ Time Frame: 7 days ]
  • Hospital length of stay [ Time Frame: 7 days ]
  • Number of ventilator days [ Time Frame: 7 days ]
  • Mortality [ Time Frame: 7 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Cumulative Chloride Dose on Development of Acute Kidney Injury in Critically Ill Children
Official Title Retrospective Investigation of Chloride Dosing and Its Effect on Acute Kidney Injury
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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Acute Kidney Injury
Intervention Not Provided
Study Groups/Cohorts
  • High Chloride Dose
    Patients receiving high dosing of chloride
  • Low Chloride Dose
    Patients receiving low dosing of chloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 10, 2014)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Month to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02188602
Other Study ID Numbers 27752
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: Weiwen V Shih, MD Stanford University
PRS Account Stanford University
Verification Date July 2014