- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01406041
Disturbance of Water and Sodium Metabolism After Surgery of Sellar Lesions, and Correspond Clinical Strategy
March 17, 2020 updated by: Pan Jun, Southern Medical University, China
The fluid and electrolyte imbalance (FEI) is pretty common encountered during the clinical process of patients suffered sellar lesions.
Moreover, if the patients are undergone the surgery for remove the lesion, FEI happens in all cases without exception.
Hypo- and hyper-natremia is the most common electrolyte disorder, which is directly correlated to the patients' outcome.
However, in clinical works, different sellar diseases cause variant features of FEI.
For example, after the surgery of craniopharyngioma, the hyponatremia and hypernatremia always happen alternatively even without any precursor manifestation.
Under this situation, it is quite difficult for fluid supplement.
In contrast, the severe FEI will cause poor outcome, even death.
So it is necessary to systematically collect and review the clinical data of sellar lesions.
Through the analysis of variant FEI patterns of sellar diseases, more precise strategy for clinical fluid replacement will be proposed.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
350
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yuntao Lu, PI
- Phone Number: +86-13632101002
- Email: lllu2000yun@gmail.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510515
- Recruiting
- The department of Neurosurgery, Nanfang hospital
-
Contact:
- Yiping Mo, Dr.
- Phone Number: +86-2061641806
- Email: lllu2000@163.com
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patients presented in our department suffered with sellar diseases
Description
Inclusion Criteria:
- 1. Suffered with sellar disease
- 2. Udergone surgery
- 3. Have sufficient presurgical and postsurgical clinical data (Including MRI, CT, physical and chemical detection results)
Exclusion Criteria:
- 1. Without sufficitent clincal data
- 2. No surgery
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Diseases
1. Pituitary adenomas; 2. Craniopharyngioma; 3. Sellar germinoma; 4. Sellar tuberalis meningioma; 5. Hypophystis; 6. Sellar glioma; 7. Rathke's cleft cyst; 8. Hypothalamic hamartoma
|
CVP, Urine volume per day, Blood electrolytes, Urine sodium per day, Pituitrin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood sodium
Time Frame: 24 hours
|
Normal: 135~155
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Urine sodium
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
February 1, 2011
Primary Completion (Actual)
January 30, 2020
Study Completion (Anticipated)
May 12, 2021
Study Registration Dates
First Submitted
July 28, 2011
First Submitted That Met QC Criteria
July 28, 2011
First Posted (Estimate)
July 29, 2011
Study Record Updates
Last Update Posted (Actual)
March 19, 2020
Last Update Submitted That Met QC Criteria
March 17, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- The department of Neurosurgery
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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