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
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Diabetes Insipidus
• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor
• Sellar and Suprasellar Masses

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

External Links

•   Mayo Clinic Clinical Trials