NCT02937441

Brief Summary

The purpose of this study is to determine cerebral edema with evaluation of measurement of diameter of optic nerve sheath.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

September 23, 2016

Last Update Submit

February 1, 2019

Conditions

Cerebral Edema

Keywords

C10.228.140.187

Outcome Measures

Primary Outcomes (1)

  • Optic Nerve Sheath diameters will be measured from 3 mm back of globe.

    Optic Nerve Sheath diameters will be measured in Children Having Diabetic Ketoacidosis and compared with normal conditions at polyclinic.

    March 2017

Interventions

Ultrasonic MeasurementOTHER

How we measure; 1. First measurement shall be taken in 4 hours. 2. Second measurement shall be taken at 12 hours in mild and 12-18 hours measurement shall be taken for severe diabetic ketoacidosis, 3. Third measurement shall be taken after fluid treatment. 4. Fourth measurement shall be taken at patients polyclinic control.

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

General

You may qualify if:

  • Fluid treatment shall be started in 4 hours in our or other Emergency Care

You may not qualify if:

  • Fluid treatment was started over four hours in other Emergency Care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Brain Edema

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Özlem T Kendir, Dr. Fellow

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow

Study Record Dates

First Submitted

September 23, 2016

First Posted

October 18, 2016

Study Start

August 1, 2016

Primary Completion

March 1, 2017

Study Completion

June 1, 2017

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

TU(1)