The Patients Suffered With Sellar DiseasesNCT01406041
Disturbance of Water and Sodium Metabolism After Surgery of Sellar Lesions, and Correspond Clinical Strategy
An observational study of The Patients Suffered With Sellar Diseases and The Fluid and Electrolyte Imbalance Happened After Surgery, run by Southern Medical University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- The Patients Suffered With Sellar Diseases, The Fluid and Electrolyte Imbalance Happened After Surgery
- What is being tested?
- Chemical and physical detection
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- Feb 2011to 12 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients presented in our department suffered with sellar diseases
Who may be able to join
- 1. Suffered with sellar disease
- 2. Udergone surgery
- 3. Have sufficient presurgical and postsurgical clinical data (Including MRI, CT, physical and chemical detection results)
Who cannot join
- 1. Without sufficitent clincal data
- 2. No surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The department of Neurosurgery, Nanfang hospital
Guangzhou, Guangdong, 510515
Yiping Mo, Dr., +86-2061641806, lllu2000@163.com
About this study
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.
- Conditions
- The Patients Suffered With Sellar Diseases, The Fluid and Electrolyte Imbalance Happened After Surgery
- Being tested
- Chemical and physical detection
- Keywords
- Fluid and electrolyte imbalance, Hyponatremia, Hypernatremia, Electrolytes disorder
- Medical subject headings
- Hyponatremia, Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemical and physical detectionBiological
CVP, Urine volume per day, Blood electrolytes, Urine sodium per day, Pituitrin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Chemical and physical detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood sodium
Normal: 135~155
Measured: 24 hours
Secondary outcomes (1)
Urine sodium
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startFeb 2011
- Primary completion30 Jan 2020
- Study completion12 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Patients Suffered With Sellar DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Jun, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406041
- Sponsor's protocol ID
- The department of Neurosurgery
- Status last verified
- Mar 2020
- First submitted
- 28 Jul 2011
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disturbance of Water and Sodium Metabolism After Surgery of Sellar Lesions, and Correspond Clinical Strategy
- ClinicalTrials.gov ID
- NCT01406041
- Acronym / sponsor ID
- The department of Neurosurgery
- Conditions
- The Patients Suffered With Sellar Diseases, The Fluid and Electrolyte Imbalance Happened After Surgery
- Keywords
- Fluid and electrolyte imbalance, Hyponatremia, Hypernatremia, Electrolytes disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Southern Medical University, ChinaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 12 May 2021 (estimated)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diseases | – | Biological: Chemical and physical detection1. Pituitary adenomas; 2. Craniopharyngioma; 3. Sellar germinoma; 4. Sellar tuberalis meningioma; 5. Hypophystis; 6. Sellar glioma; 7. Rathke's cleft cyst; 8. Hypothalamic hamartoma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients presented in our department suffered with sellar diseases
Key inclusion criteria (3 listed)
- 1. Suffered with sellar disease
- 2. Udergone surgery
- 3. Have sufficient presurgical and postsurgical clinical data (Including MRI, CT, physical and chemical detection results)
Key exclusion criteria (2 listed)
- 1. Without sufficitent clincal data
- 2. No surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemical and physical detectionCVP, Urine volume per day, Blood electrolytes, Urine sodium per day, Pituitrin | Biological | Diseases |
Primary outcome
Blood sodium
Time frame: 24 hours
Normal: 135~155
1 secondary outcome
Urine sodium
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Patients Suffered With Sellar Diseases and The Fluid and Electrolyte Imbalance Happened After Surgery, run by Southern Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuntao Lu, PI (+86-13632101002, lllu2000yun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood sodium (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.