Could a simple drug during brain surgery prevent Life-Threatening sodium swings?
NCT ID NCT07712328
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This trial tests whether giving a low-dose infusion of desmopressin (dDAVP) during surgery for complex brain tumors around the pituitary gland can prevent dangerously high sodium levels (hypernatremia) in the first 24 hours after surgery. High sodium can cause brain bleeding, seizures, or coma. The study includes adults aged 18–75 with large sellar region tumors who are at high risk for diabetes insipidus. Half receive desmopressin during surgery; the other half receive a placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- desmopressin (dDAVP) given as a continuous intravenous infusion during surgery
- What this could lead to
- If it works, this could become a standard preventive treatment to reduce the risk of severe complications like brain bleeding or seizures after surgery for these tumors.
- What could go wrong
- This is a single-center, open-label trial, so results may be less reliable than a blinded study. The drug may not reduce sodium spikes or could cause other side effects like water retention.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 152 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * (1) Demographic information: Age 18 to 75 years, any gender, any race. (2) Target disease: Preoperative pituitary MRI-confirmed diagnosis of sellar region lesions requiring surgical intervention, including craniopharyngioma, pituitary adenoma, and other sellar region lesions. The patient must meet at least two of the following high-risk criteria: 1. Preoperatively confirmed central diabetes insipidus (CDI); 2. Maximum tumor diameter \> 3 cm with imaging evidence of suprasellar extension; 3. Imaging evidence of close anatomical relationship with the pituitary stalk, posterior pituitary, or hypothalamus, including compression, encasement, or invasion; 4. Estimated surgical duration \> 4 hours. (3) Health status: Adequate organ function to tolerate surgery, and no contraindications to desmopressin (dDAVP) administration. American Society of Anesthesiologists (ASA) Physical Status classification I, II, or III, with comorbid conditions being stably controlled prior to surgery. (4) Concomitant medication: Patients must have discontinued medications that may significantly affect intraoperative water-electrolyte balance (e.g., thiazide diuretics, antipsychotics such as chlorpromazine, olanzapine, clozapine, carbamazepine, etc.) prior to surgery, until the investigator assesses the risk as acceptable Exclusion Criteria: * (1) Patients with pre-existing comorbidities affecting water and salt metabolism, including but not limited to: 1. Renal insufficiency (dDAVP is predominantly excreted unchanged by the kidneys; renal impairment may significantly prolong its half-life and increase the risk of hyponatremia); 2. Cardiac insufficiency (dDAVP-induced water and sodium retention may increase circulating blood volume and potentially precipitate heart failure); 3. Untreated adrenal insufficiency (cortisol deficiency impairs free water excretion); 4. Uncorrected hyponatremia prior to surgery. (2) Patients requiring concomitant use of medications that may induce hyponatremia and cannot be temporarily discontinued, including but not limited to chlorpromazine, olanzapine, clozapine, carbamazepine, thiazide diuretics, etc. (3) Pregnant or breastfeeding patients. (4) Patients with known hypersensitivity to dDAVP or any of its excipients. (5) Patients currently participating in any other clinical trial. If the patient has previously participated in a drug clinical trial, the time from the last dose of the investigational drug must exceed 4 weeks. (6) Any other conditions deemed unsuitable for participation in this study by the investigator's judgment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Huashan Hospital
Shanghai, China
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