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Disturbance of Water and Sodium Metabolism After Surgery of Sellar Lesions, and Correspond Clinical Strategy

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ClinicalTrials.gov Identifier: NCT01406041
Recruitment Status : Unknown
Verified April 2011 by Southern Medical University, China.
Recruitment status was:  Recruiting
First Posted : July 29, 2011
Last Update Posted : July 29, 2011
Information provided by:
Southern Medical University, China

Brief Summary:
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.

Condition or disease Intervention/treatment
The Patients Suffered With Sellar Diseases The Fluid and Electrolyte Imbalance Happened After Surgery Biological: Chemical and physical detection

Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Study Start Date : February 2011
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2014

Group/Cohort Intervention/treatment
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
Biological: Chemical and physical detection
CVP, Urine volume per day, Blood electrolytes, Urine sodium per day, Pituitrin

Primary Outcome Measures :
  1. Blood sodium [ Time Frame: 24 hours ]
    Normal: 135~155

Secondary Outcome Measures :
  1. Urine sodium [ Time Frame: 24 hours ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients presented in our department suffered with sellar diseases

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406041

Contact: Yuntao Lu, PI +86-13632101002 lllu2000yun@gmail.com

China, Guangdong
The department of Neurosurgery, Nanfang hospital Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Yiping Mo, Dr.    +86-2061641806    lllu2000@163.com   
Sponsors and Collaborators
Southern Medical University, China

Responsible Party: Yuntao Lu/principal investigator, The department of neurosurgery
ClinicalTrials.gov Identifier: NCT01406041     History of Changes
Other Study ID Numbers: The department of Neurosurgery
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: July 29, 2011
Last Verified: April 2011

Keywords provided by Southern Medical University, China:
Fluid and electrolyte imbalance
Electrolytes disorder