Clinical trial NCT06742060: The Trend of Copeptin Levels and Its Clinical Value for Postoperative CDI in Pediatric Patients After NSI in ICU
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Insipidus, Neurohypophyseal
Copeptin Blood Levels
Copeptin
Neurosurgical Intervention
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 100
Sex: ALL
Minimum age (years): 29
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients after neurosurgical intervention in ICU

Brief 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 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.

Eligibility 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

Primary outcomes:
measure: C0-C6:The serum concentration of copeptin after NSI at T0 -T6
timeFrame: Day0-6
Secondary outcomes:
measure: ROC curve
timeFrame: Day0-6
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: guoping Lu
role: PRINCIPAL_INVESTIGATOR
References: