Diabetes Insipidus, NeurohypophysealNCT06742060
The Trend of Copeptin Levels and Its Clinical Value for Postoperative CDI in Pediatric Patients After NSI in ICU
An observational study of Diabetes Insipidus, Neurohypophyseal and Copeptin Blood Levels, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Central diabetes insipidus (CDI),a disease caused by the decrease of AVP (a hormone involved in the control of water-electrolyte balance ) secretion and characerized by polyuria, is a common complication after neurosurgerical intervention and there is a lack of diagnostic criteria.Since the surgry casuses damage to… Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- Diabetes Insipidus, Neurohypophyseal, Copeptin Blood Levels, Copeptin
- What is being tested?
- serum copeptin levels
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 29 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients after neurosurgical intervention in ICU
Who may be able to join
- Male and female,age ≥29 days and <18 years
- After neurosurgical intervention
- The patient agrees to comply with the requirements of the program, including follow-up visits and other related matters
Who cannot join
- Structural diseases of the genitourinary system (with the possibility of nephrogenic diabetes insipidus)
- Preoperative symptoms of diabetes insipidus
- Diabetes mellitus (HbA1c >8.5%)
- Drugs causing excessive drinking and urination (e.g., sodium-glucose cotransporter-2 inhibitors and diuretics)
- Lack of follow-up data after 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
gangfeng Yan, +86 15900603082, jinyi036@126.com
About this study
Official title: A Study on the Trend of Serum Copeptin Levels and Its Clinical Value for Postoperative Central Diabetes Insipidus in Pediatric Patients After Neurosurgical Intervention in Intensive Care Unit
Central diabetes insipidus (CDI),a disease caused by the decrease of AVP (a hormone involved in the control of water-electrolyte balance ) secretion and characerized by polyuria, is a common complication after neurosurgerical intervention and there is a lack of diagnostic criteria.Since the surgry casuses damage to patients' AVP-secreting neuronal cells, transient CDI (t-CDI) usually occurs 24-48h postoperatively and gradually resolves in about 10 days.However,permanent CDI (p-CDI) occurs in a small percentage of patients.Copeptin is a fragment of AVP, which has been shown to response the secretion of AVP.Multiple international studies have identified clinical applications for the use of copeptin to differentially diagnose adults with CDI , to assess electrolyte disturbances associated with AVP regulation, and to predict postoperative CDI after pituitary surgery.This study aims to investigate the trend of serum copeptin levels and its clinical value for postoperative CDI in pediatric patients after neurosurgerical intervention in ICU.
Read the detailed description
In children and adolescents, the concentration distribution of copeptin has been gradually explored in recent years,but International studies have not yet shown the trend of copeptin levels in pediatric patients after neurosurgical intervention and its value in predicting CDI.
The primary objective of this study is to investigate the trend of serum copetin levels in ICU children after neurosurgerical intervention and compare differences of copeptide levels in children with CDI (t-CDI, p-CDI) and non-CDI. The secondary objective is to evaluate the optimal detection time and CUT OFF of copeptin in predicting the postoperative secondary CDI .
Blood sampling time points of serum copeptin levels are listed as follow:
presurgery(T0), 1h (T1), 1 day (T2), 2 days (T3), 3 days (T4), 4 days (T5), 5 day (T6) after surgury.
- Conditions
- Diabetes Insipidus, Neurohypophyseal, Copeptin Blood Levels, Copeptin, Neurosurgical Intervention
- Being tested
- serum copeptin levels
- Medical subject headings
- Diabetes Insipidus, Neurogenic, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum copeptin levelsDiagnostic test
For children who met the entry criteria, the blood samples were collected preoperatively (T0), 1h postoperatively (T1), 1 day postoperatively (T2), 2 days postoperatively (T3), 3 days postoperatively (T4), 4 days postoperatively (T5), 5 days postoperatively (T6) to test serum and peptide levels.
What is being measured
The primary outcome is the main question the study is designed to answer.
C0-C6:The serum concentration of copeptin after NSI at T0 -T6
The serum concentration of copeptin after NSI at T0 -T6 to evaluate the trend of copetin level after NSI and its difference in children with CDI(t-CDI and p-CDI) and non-CDI
Measured: Day0-6
Secondary outcomes (1)
ROC curve
The curve of false positive rate and sensitivity with different critical point of serum copeptin level to diagnose CDI
Measured: Day0-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start22 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Insipidus, NeurohypophysealStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- guoping Lu, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742060
- Sponsor's protocol ID
- fdpicu-30
- Status last verified
- Feb 2026
- First submitted
- 16 Dec 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Trend of Serum Copeptin Levels and Its Clinical Value for Postoperative Central Diabetes Insipidus in Pediatric Patients After Neurosurgical Intervention in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06742060
- Acronym / sponsor ID
- fdpicu-30
- Conditions
- Diabetes Insipidus, Neurohypophyseal, Copeptin Blood Levels, Copeptin, Neurosurgical Intervention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Dec 2024 (actual)
- 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.
Central diabetes insipidus (CDI),a disease caused by the decrease of AVP (a hormone involved in the control of water-electrolyte balance ) secretion and characerized by polyuria, is a common complication after neurosurgerical intervention and there is a lack of diagnostic criteria.Since the surgry casuses damage to patients' AVP-secreting neuronal cells, transient CDI (t-CDI) usually occurs 24-48h postoperatively and gradually resolves in about 10 days.However,permanent CDI (p-CDI) occurs in a small percentage of patients.Copeptin is a fragment of AVP, which has been shown to response the secretion of AVP.Multiple international studies have identified clinical applications for the use of copeptin to differentially diagnose adults with CDI , to assess electrolyte disturbances associated with AVP regulation, and to predict postoperative CDI after pituitary surgery.This study aims to investigate the trend of serum copeptin levels and its clinical value for postoperative CDI in pediatric patients after neurosurgerical intervention in ICU.
Detailed description
In children and adolescents, the concentration distribution of copeptin has been gradually explored in recent years,but International studies have not yet shown the trend of copeptin levels in pediatric patients after neurosurgical intervention and its value in predicting CDI.
The primary objective of this study is to investigate the trend of serum copetin levels in ICU children after neurosurgerical intervention and compare differences of copeptide levels in children with CDI (t-CDI, p-CDI) and non-CDI. The secondary objective is to evaluate the optimal detection time and CUT OFF of copeptin in predicting the postoperative secondary CDI .
Blood sampling time points of serum copeptin levels are listed as follow:
presurgery(T0), 1h (T1), 1 day (T2), 2 days (T3), 3 days (T4), 4 days (T5), 5 day (T6) after surgury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients after neurosurgical intervention in ICU
Key inclusion criteria (3 listed)
- Male and female,age ≥29 days and <18 years
- After neurosurgical intervention
- The patient agrees to comply with the requirements of the program, including follow-up visits and other related matters
Key exclusion criteria (5 listed)
- Structural diseases of the genitourinary system (with the possibility of nephrogenic diabetes insipidus)
- Preoperative symptoms of diabetes insipidus
- Diabetes mellitus (HbA1c >8.5%)
- Drugs causing excessive drinking and urination (e.g., sodium-glucose cotransporter-2 inhibitors and diuretics)
- Lack of follow-up data after 3 months
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 |
|---|---|---|
| serum copeptin levelsFor children who met the entry criteria, the blood samples were collected preoperatively (T0), 1h postoperatively (T1), 1 day postoperatively (T2), 2 days postoperatively (T3), 3 days postoperatively (T4), 4 days postoperatively (T5), 5 days postoperatively (T6) to test serum and peptide levels. | Diagnostic test | – |
Primary outcome
C0-C6:The serum concentration of copeptin after NSI at T0 -T6
Time frame: Day0-6
The serum concentration of copeptin after NSI at T0 -T6 to evaluate the trend of copetin level after NSI and its difference in children with CDI(t-CDI and p-CDI) and non-CDI
1 secondary outcome
ROC curve
Time frame: Day0-6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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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.
guoping Lu principal investigator
Children's Hospital of Fudan 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 Diabetes Insipidus, Neurohypophyseal and Copeptin Blood Levels, run by Children's Hospital of Fudan University at 1 site in China.
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 3 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact gangfeng Yan (+86 15900603082, jinyi036@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C0-C6:The serum concentration of copeptin after NSI at T0 -T6 (time frame: Day0-6). 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 17 Feb 2026.