Acute Kidney InjuryNCT02188602
Effect of Cumulative Chloride Dose on Development of Acute Kidney Injury in Critically Ill Children
An observational study of Acute Kidney Injury, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- age less than 18 years
- PICU admitting diagnosis of sepsis, respiratory failure, or hepatic failure.
Who cannot join
- hyponatremia or hypernatremia at PICU admission
- preexisting diagnosis of End-stage renal disease or renal transplant
- presence of neurologic comorbidities.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital
Palo Alto, California, 94303
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High Chloride Dose | Patients receiving high dosing of chloride | |
| Low Chloride Dose | Patients receiving low dosing of chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
or sooner if death or discharged
Measured: 7 days
Secondary outcomes (4)
PICU length of stay
Measured: 7 days
Hospital length of stay
Measured: 7 days
Number of ventilator days
Measured: 7 days
Mortality
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJul 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: Researcher left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weiwen V Shih, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188602
- Sponsor's protocol ID
- 27752
- Status last verified
- Aug 2022
- First submitted
- 19 Jul 2013
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Investigation of Chloride Dosing and Its Effect on Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02188602
- Acronym / sponsor ID
- 27752
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Researcher left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Chloride Dose | – | –Patients receiving high dosing of chloride |
| Low Chloride Dose | – | –Patients receiving low dosing of chloride |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- age less than 18 years
- PICU admitting diagnosis of sepsis, respiratory failure, or hepatic failure.
Key exclusion criteria (3 listed)
- hyponatremia or hypernatremia at PICU admission
- preexisting diagnosis of End-stage renal disease or renal transplant
- presence of neurologic comorbidities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute Kidney Injury
Time frame: 7 days
or sooner if death or discharged
4 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiwen V Shih, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Injury (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.