The Trend of Copeptin Levels and Its Clinical Value for Postoperative CDI in Pediatric Patients After NSI in ICU

NCT06742060 | Recruiting

• 1 other identifier: fdpicu-30
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Copeptin Blood Levels; Copeptin; Neurosurgical Intervention; Diabetes Insipidus, Neurohypophyseal

Outcome Measures

Primary Outcomes (1)

• 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

  Day0-6

Secondary Outcomes (1)

• ROC curve

  Day0-6

Interventions

serum copeptin levels DIAGNOSTIC_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.

Eligibility Criteria

• Age: 29 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients after neurosurgical intervention in ICU

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

MeSH Terms

Conditions

Diabetes Insipidus, Neurogenic; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• guoping Lu

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

gangfeng Yan

CONTACT

+86 15900603082; jinyi036@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: November 22, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

CN (1)