Diabetic Ketoacidosis ChildrenCOPACDNCT02994316
Plasma Copeptin Levels in Children With Diabetic Ketoacidosis
A study testing Copeptine dosage in children with diabetic ketoacidosis at diagnosis in people with Diabetic Ketoacidosis Children, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Children with diabetic ketoacidosis risk neurological complications such as cerebral edema with high morbidity. To prevent cerebral edema, it is essential to control correction of hypovolemia, hyperglycemia and natremia. Markers usually used in management of diabetic ketoacidosis don't always permit an optimal care. Read more about this study
- Who is it for?
- Ages 6 months to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Ketoacidosis Children
- What is being tested?
- Copeptine dosage in children with diabetic ketoacidosis at diagnosis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2016to 25 Nov 2018
- Phase
- Interventional
- 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 6 months to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between 6 months and 16 years
- Diagnosis of diabetes mellitus type 1 (cardinal syndrome, blood glucose level > 7 mmol/L in the fasted state or > 11 mmol/L not in fasted state, no signs for another type of diabetes mellitus)
- Children who need an exclusive intravenous rehydration for 36 hours
- Written informed consent of legal representative and of the child if possible
- Beneficiary of State Social Insurance
Who cannot join
- Child under the age of 6 months or older than 16 years
- Non exclusive intravenous réhydration for at least 36 hours
- Child moved from another institution and for whom an intravenous rehydration or insulin therapy have already begun
- Non type 1 diabetes mellitus
- Non affiliation to State Social Insurance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Plasma Copeptin Levels in Management of Children With Diabetic Ketoacidosis
Children with diabetic ketoacidosis risk neurological complications such as cerebral edema with high morbidity. To prevent cerebral edema, it is essential to control correction of hypovolemia, hyperglycemia and natremia. Markers usually used in management of diabetic ketoacidosis don't always permit an optimal care.
Plasma copeptin levels reflect vasopressin secretion which is high in diabetic ketoacidosis.
Therefore, monitoring of plasma copeptin levels could be of interest in children with diabetic ketoacidosis and risk of sévère neurological complications.
Read the detailed description
Biological risk factors for severe complications in diabetic ketoacidosis are described (high blood glucose level, metabolic acidosis, high blood urea nitrogen, hypernatremia) but their dosage and monitoring are not sufficient to distinguish high risks situations.
Several studies suggest that vasopressin secretion is increased in diabetic ketoacidosis. This high level could be important in occurrence of cerebral edema. Monitoring of vasopressin levels could then have an interest in patients at risk of severe complications but reliability of copeptin dosage depend of collection conditions and its packaging. These conditions are difficult to ensure and copeptin dosage, which represent vasopressin secretion, is easier to perform.
Copeptin dosage could then be a new biological marker, more accurate and specific, for an optimal management of diabetic ketoacidosis.
This type of study has never been carried out neither in children nor in adults.
- Conditions
- Diabetic Ketoacidosis Children
- Being tested
- Copeptine dosage in children with diabetic ketoacidosis at diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copeptine dosage in children with diabetic ketoacidosis at diagnosisOther
Blood collection of 3 mL for copeptin dosage will be taken at different times in the first hours of management of diabetic ketoacodosis in children under the age of 16 years
| Study group | Role | What they receive |
|---|---|---|
| children under the age of 16 diabete with ketoacidosis | Experimental | At diagnosis mellitus type 1 (measure of blood glucose level) bicarbonate levels will be measured and children will included in the arm "with ketoacidosis (bicarbonate < 15mmol/L) Receives: Other: Copeptine dosage in children with diabetic ketoacidosis at diagnosis |
| children under the age of 16 diabete without ketoacidosis | Sham comparator | At diagnosis mellitus type 1 (measure of blood glucose level) bicarbonate levels will be measured and children will included in the arm "without ketoacodosis (bicarbonate> 15 mmol/L) Receives: Other: Copeptine dosage in children with diabetic ketoacidosis at diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interest of copeptin dosage as a severity marker in children under the age of 16 with diabatic ketoacidosis
Study of correlation between copeptin levels and metabolic acidosis management of diabatic ketoacidosis in children
Measured: 36 hours
Secondary outcomes (1)
Correlation between plasma copeptin levels and other markers used in management of diabatic ketoacidosis in the first 36 hours after diagnosis- Plasma copeptin levels at diagnosis of diabate mellitus type 1 without ketoacidosis in children
Interest of copeptin dosage as a new marker of diabatic ketoacidosis severy compared to other used markers
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start3 Oct 2016
- Primary completion23 Nov 2018
- Study completion25 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Ketoacidosis ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GILLES GC CAMBONIE, PU PH, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994316
- Sponsor's protocol ID
- 9649
- Acronym
- COPACD
- Status last verified
- Oct 2019
- First submitted
- 28 Nov 2016
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Plasma Copeptin Levels in Management of Children With Diabetic Ketoacidosis
- ClinicalTrials.gov ID
- NCT02994316
- Acronym / sponsor ID
- COPACD / 9649
- Conditions
- Diabetic Ketoacidosis Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 23 Nov 2018 (actual)
- Study completion
- 25 Nov 2018 (actual)
- First posted
- 15 Dec 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.
Children with diabetic ketoacidosis risk neurological complications such as cerebral edema with high morbidity. To prevent cerebral edema, it is essential to control correction of hypovolemia, hyperglycemia and natremia. Markers usually used in management of diabetic ketoacidosis don't always permit an optimal care.
Plasma copeptin levels reflect vasopressin secretion which is high in diabetic ketoacidosis.
Therefore, monitoring of plasma copeptin levels could be of interest in children with diabetic ketoacidosis and risk of sévère neurological complications.
Detailed description
Biological risk factors for severe complications in diabetic ketoacidosis are described (high blood glucose level, metabolic acidosis, high blood urea nitrogen, hypernatremia) but their dosage and monitoring are not sufficient to distinguish high risks situations.
Several studies suggest that vasopressin secretion is increased in diabetic ketoacidosis. This high level could be important in occurrence of cerebral edema. Monitoring of vasopressin levels could then have an interest in patients at risk of severe complications but reliability of copeptin dosage depend of collection conditions and its packaging. These conditions are difficult to ensure and copeptin dosage, which represent vasopressin secretion, is easier to perform.
Copeptin dosage could then be a new biological marker, more accurate and specific, for an optimal management of diabetic ketoacidosis.
This type of study has never been carried out neither in children nor in adults.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children under the age of 16 diabete with ketoacidosis | Experimental | Other: Copeptine dosage in children with diabetic ketoacidosis at diagnosisAt diagnosis mellitus type 1 (measure of blood glucose level) bicarbonate levels will be measured and children will included in the arm "with ketoacidosis (bicarbonate < 15mmol/L) |
| children under the age of 16 diabete without ketoacidosis | Sham comparator | Other: Copeptine dosage in children with diabetic ketoacidosis at diagnosisAt diagnosis mellitus type 1 (measure of blood glucose level) bicarbonate levels will be measured and children will included in the arm "without ketoacodosis (bicarbonate> 15 mmol/L) |
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children between 6 months and 16 years
- Diagnosis of diabetes mellitus type 1 (cardinal syndrome, blood glucose level > 7 mmol/L in the fasted state or > 11 mmol/L not in fasted state, no signs for another type of diabetes mellitus)
- Children who need an exclusive intravenous rehydration for 36 hours
- Written informed consent of legal representative and of the child if possible
- Beneficiary of State Social Insurance
Key exclusion criteria (5 listed)
- Child under the age of 6 months or older than 16 years
- Non exclusive intravenous réhydration for at least 36 hours
- Child moved from another institution and for whom an intravenous rehydration or insulin therapy have already begun
- Non type 1 diabetes mellitus
- Non affiliation to State Social Insurance
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 |
|---|---|---|
| Copeptine dosage in children with diabetic ketoacidosis at diagnosisBlood collection of 3 mL for copeptin dosage will be taken at different times in the first hours of management of diabetic ketoacodosis in children under the age of 16 years | Other | children under the age of 16 diabete with ketoacidosis, children under the age of 16 diabete without ketoacidosis |
Primary outcome
Interest of copeptin dosage as a severity marker in children under the age of 16 with diabatic ketoacidosis
Time frame: 36 hours
Study of correlation between copeptin levels and metabolic acidosis management of diabatic ketoacidosis in children
1 secondary outcome
Correlation between plasma copeptin levels and other markers used in management of diabatic ketoacidosis in the first 36 hours after diagnosis- Plasma copeptin levels at diagnosis of diabate mellitus type 1 without ketoacidosis in children
Time frame: 36 hours
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 31 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Diabetic Ketoacidosis Children
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General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery
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Hemoglobin Levels and Resolution Time of Diabetic Ketoacidosis in Pediatric Patients
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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.
GILLES GC CAMBONIE, PU PH study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Copeptine dosage in children with diabetic ketoacidosis at diagnosis in people with Diabetic Ketoacidosis Children, run by University Hospital, Montpellier at 1 site in France.
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 5 inclusion and 5 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 31 Oct 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 France. 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. Some participants in this study may receive a placebo. 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?
Interest of copeptin dosage as a severity marker in children under the age of 16 with diabatic ketoacidosis (time frame: 36 hours). 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 31 Oct 2019.