Investigating copeptin levels in children after neurosurgery for diabetes insipidus
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
This study looks at how copeptin levels change in children after brain surgery to see if it can help predict who will develop diabetes insipidus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 29 Days to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06742060 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the trend of serum copeptin levels in pediatric patients following neurosurgical interventions. It focuses on comparing copeptin levels in children who develop transient or permanent central diabetes insipidus (CDI) against those who do not. Blood samples will be collected at various time points post-surgery to assess the relationship between copeptin levels and the occurrence of CDI. The study seeks to establish optimal detection times and cutoff values for copeptin in predicting postoperative CDI.
Who should consider this trial
Good fit: Ideal candidates include children aged 29 days to under 18 years who have undergone neurosurgical intervention.
Not a fit: Patients with pre-existing diabetes insipidus or structural diseases of the genitourinary system may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable diagnostic tool for predicting central diabetes insipidus in pediatric patients after neurosurgery.
How similar studies have performed: While international studies have explored copeptin's clinical applications in adults, this specific approach in pediatric patients after neurosurgery is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Shanghai, Shanghai Municipality
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: guoping Lu — Children's Hospital of Fudan University
- Study coordinator: gangfeng Yan
- Email: jinyi036@126.com
- Phone: +86 15900603082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.