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

February 12, 2026 updated by: Children's Hospital of Fudan University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Diagnostic test: serum copeptin levels

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: gangfeng Yan
Phone Number: +86 15900603082
Email: jinyi036@126.com

Study Locations

China
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 201102
    - Recruiting
    - Children's Hospital of Fudan University
    - Contact:
      
      gangfeng Yan
      
      Phone Number: +86 15900603082
      
      Email: jinyi036@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients after neurosurgical intervention in ICU

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day0-6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ROC curve Time Frame: Day0-6	The curve of false positive rate and sensitivity with different critical point of serum copeptin level to diagnose CDI	Day0-6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Investigators

Principal Investigator: guoping Lu, Children's Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria