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

Completed

• Conditions: Pituitary Tumor; Sellar and Suprasellar Masses

• Registration Number: NCT04369703
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2020-01-28
• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-04-29
• Study First Posted: 2020-04-30
• Primary Completion: 2022-04-29
• Study Completion: 2022-04-29
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

* Patients with sellar and suprasellar masses who undergo neurosurgical procedure at Mayo Clinic Rochester.

Exclusion Criteria

* Patients with preexisting CDI.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predict lack of central diabetes insipidus development	2 years	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
Assess relative change	2 years	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.
Predict central diabetes insipidus development	2 years	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States