Evaluation of the Cerebral Edema in Children Having Diabetic Ketoacidosis

February 1, 2019 updated by: Ozlem Tolu Kendir, Cukurova University

Evaluation of the Cerebral Edema With Measurement of Optic Nerve Sheath in Children Having Diabetic Ketoacidosis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine cerebral edema with evaluation of measurement of diameter of optic nerve sheath. For that, If patients have Fluid treatment shall be started in 4 hours in our or other Emergency Care, they will be included our study. If not, they will be out of our study.

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 polyclinic control. So, after all measurements will be hand and all data will be analyzed with statistical program. After that all outcome will be discussed and compared with patient at normal conditions at their polyclinic visit.

Study Type

Observational

Enrollment (Actual)

31

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

  • Turkey
      • Adana, Turkey
        • Çukurova University

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

Probability Sample

Study Population

General

Description

Inclusion Criteria:

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

Exclusion Criteria:

Fluid treatment was started over four hours in other Emergency Care

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optic Nerve Sheath diameters will be measured from 3 mm back of globe.
Time Frame: March 2017
Optic Nerve Sheath diameters will be measured in Children Having Diabetic Ketoacidosis and compared with normal conditions at polyclinic.
March 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Investigators

  • Principal Investigator: Özlem T Kendir, Dr. Fellow, Çukurova 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 (Actual)

August 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

October 17, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUTF-GOKAEK-55-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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