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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Southern Medical University, China.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Southern Medical University, China
ClinicalTrials.gov Identifier:
NCT01406041
First received: July 28, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

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 Intervention
The Patients Suffered With Sellar Diseases
The Fluid and Electrolyte Imbalance Happened After Surgery
Biological: Chemical and physical detection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Southern Medical University, China:

Primary Outcome Measures:
  • Blood sodium [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Normal: 135~155


Secondary Outcome Measures:
  • Urine sodium [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: February 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Biological: Chemical and physical detection
CVP, Urine volume per day, Blood electrolytes, Urine sodium per day, Pituitrin

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients presented in our department suffered with sellar diseases

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01406041

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

Locations
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
  More Information

No publications provided

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
Study First Received: July 28, 2011
Last Updated: July 28, 2011
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 27, 2014