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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age29-18
SponsorChildren's Hospital of Fudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

Pediatric patients after neurosurgical intervention in ICU

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

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

Time frame
Day0-6

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

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