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NCT02937441 Clinical Trial

Evaluation of the Cerebral Edema in Children Having Diabetic Ketoacidosis

Cerebral Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02937441
Other study ID # CUTF-GOKAEK-55-38
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2016
Est. completion date June 2017

Study information
Verified date February 2019
Source Cukurova University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date June 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 1 Month to 18 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Turkey Cukurova University Adana

Sponsors (1)
Lead Sponsor Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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