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Идёт набор NCT06742060

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

— Наблюдательное Diabetes Insipidus, Neurohypophyseal Copeptin Blood Levels Copeptin Neurosurgical Intervention

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: serum copeptin levels.
Кому может быть актуально
Состояния в реестре: Diabetes Insipidus, Neurohypophyseal, Copeptin Blood Levels, Copeptin, Neurosurgical Intervention. Базовые параметры: 29 Days — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест serum copeptin levels
    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.

Первичные конечные точки

  • C0-C6:The serum concentration of copeptin after NSI at T0 -T6 [Срок оценки: Day0-6]
Вторичные конечные точки (1)
  • ROC curve [Срок оценки: Day0-6]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Children's Hospital of Fudan University — Шанхай

Идентификаторы

NCT: NCT06742060 · fdpicu-30

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗