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

June 1, 2022 updated by: Dana Erickson, Mayo Clinic
  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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

199

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55901
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with sellar and suprasellar masses.

Description

Inclusion Criteria:

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

Exclusion Criteria:

* Patients with preexisting CDI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predict central diabetes insipidus development
Time Frame: 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.
2 years
Predict lack of central diabetes insipidus development
Time Frame: 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
2 years
Assess relative change
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Dana Erickson, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2020

Primary Completion (Actual)

April 29, 2022

Study Completion (Actual)

April 29, 2022

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

April 30, 2020

Study Record Updates

Last Update Posted (Actual)

June 3, 2022

Last Update Submitted That Met QC Criteria

June 1, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-010785

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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