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NCT04369703 Clinical Trial

Copeptin as a Biomarker for Central Diabetes Insipidus Development Following Pituitary Surgery

Pituitary Tumor Clinical Trial

Official title:
Copeptin as a Biomarker for Central Diabetes Insipidus Development Following Pituitary Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04369703
Other study ID # 19-010785
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 28, 2020
Est. completion date April 29, 2022

Study information
Verified date June 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1. Access the optimal cut point value of copeptin which predicts development of central diabetes insipidus postoperatively with highest accuracy. 2. Access the optimal cut point value of copeptin which predicts the lack of central diabetes insipidus postoperatively with highest accuracy 3. Access the relative change in copeptin values between baseline and post-surgery as a predictor for diabetes insipidus development.

Description:

Patient serum levels of copeptin would be measured after phlebotomy of 3 ml of blood in EDTA tube twice a) within 1-4 hours of extubation and b) within 4-24 hours of extubation (the morning following surgery).

Recruitment information / eligibility
Status Completed
Enrollment 199
Est. completion date April 29, 2022
Est. primary completion date April 29, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria: * Patients with sellar and suprasellar masses who undergo neurosurgical procedure at Mayo Clinic Rochester. Exclusion Criteria: * Patients with preexisting CDI.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Predict central diabetes insipidus development Using the measured lab value, we will access the optimal cut point value of copeptin which predicts development of central diabetes insipidus postoperatively with highest accuracy. 2 years
Primary Predict lack of central diabetes insipidus development Using the measured lab value, we will access the optimal cut point value of copeptin which predicts the lack of central diabetes insipidus postoperatively with highest accuracy 2 years
Primary Assess relative change Using the measured lab value, we will access the relative change in copeptin values between baseline and post-surgery as a predictor for diabetes insipidus development. 2 years
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