NCT02188602

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2013

Completed
12 months until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

1.9 years

First QC Date

July 19, 2013

Last Update Submit

August 17, 2022

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Acute Kidney Injury

    or sooner if death or discharged

    7 days

Secondary Outcomes (4)

  • PICU length of stay

    7 days

  • Hospital length of stay

    7 days

  • Number of ventilator days

    7 days

  • Mortality

    7 days

Study Arms (2)

High Chloride Dose

Patients receiving high dosing of chloride

Low Chloride Dose

Patients receiving low dosing of chloride

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • age less than 18 years
  • PICU admitting diagnosis of sepsis, respiratory failure, or hepatic failure.

You may not qualify if:

  • hyponatremia or hypernatremia at PICU admission
  • preexisting diagnosis of End-stage renal disease or renal transplant
  • presence of neurologic comorbidities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Packard Children's Hospital

Palo Alto, California, 94303, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Weiwen V Shih, MD

    Stanford University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2013

First Posted

July 11, 2014

Study Start

July 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 22, 2022

Record last verified: 2022-08

Locations

US(1)