Cerebral EdemaNCT02937441
Evaluation of the Cerebral Edema in Children Having Diabetic Ketoacidosis
An observational study of Cerebral Edema, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine cerebral edema with evaluation of measurement of diameter of optic nerve sheath. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Cerebral Edema
- What is being tested?
- Ultrasonic Measurement
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2016to Jun 2017
- 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: General
Who may be able to join
- Fluid treatment shall be started in 4 hours in our or other Emergency Care
Who cannot join
- Fluid treatment was started over four hours in other Emergency Care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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;
- 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 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.
- Conditions
- Cerebral Edema
- Being tested
- Ultrasonic Measurement
- Keywords
- C10.228.140.187
- Medical subject headings
- Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic MeasurementOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: March 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral EdemaStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Tolu Kendir, Cukurova University
- Investigators
- Özlem T Kendir, Dr. Fellow, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937441
- Sponsor's protocol ID
- CUTF-GOKAEK-55-38
- Status last verified
- Feb 2019
- First submitted
- 23 Sep 2016
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cerebral Edema With Measurement of Optic Nerve Sheath in Children Having Diabetic Ketoacidosis
- ClinicalTrials.gov ID
- NCT02937441
- Acronym / sponsor ID
- CUTF-GOKAEK-55-38
- Conditions
- Cerebral Edema
- Keywords
- C10.228.140.187
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 18 Oct 2016 (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 purpose of this study is to determine cerebral edema with evaluation of measurement of diameter of optic nerve sheath.
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;
- 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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- General
Key inclusion criteria (1 listed)
- Fluid treatment shall be started in 4 hours in our or other Emergency Care
Key exclusion criteria (1 listed)
- Fluid treatment was started over four hours in other Emergency Care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonic MeasurementHow 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. | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Özlem T Kendir, Dr. Fellow principal investigator
Cukurova 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 Cerebral Edema, run by Cukurova University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Feb 2019. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Optic Nerve Sheath diameters will be measured from 3 mm back of globe. (time frame: March 2017). 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 4 Feb 2019.