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Withdrawn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
      • Palo Alto, California, United States, 94303
        • Lucile Packard Children's Hospital

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.

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

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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