An observational study in Diabetes Insipidus, Neurohypophyseal, Copeptin Blood Levels and Copeptin, sponsored by Children's Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 29 Days to 18 Years. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Children's Hospital of Fudan University · Observational
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.
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.
27 studies on the registry are indexed under Diabetes Insipidus, Neurogenic; 12 are open to participants now.
Browse Diabetes Insipidus, Neurogenic studies →Children's Hospital of Fudan University is the lead sponsor of 268 studies on the registry; 95 are open to participants now.
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Pediatric patients after neurosurgical intervention in ICU
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Time frame: Day0-6
ROC curve
The curve of false positive rate and sensitivity with different critical point of serum copeptin level to diagnose CDI
Time frame: Day0-6
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