A Phase 4 interventional study of Desmopressin (DDAVP) and Control in Craniopharyngiomas, Pituitary Macroadenoma and Sellar and Suprasellar Masses, sponsored by Zhaoyun Zhang. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Zhaoyun Zhang · Phase 4, Interventional, and Prevention
Craniopharyngiomas and giant invasive pituitary adenomas, with lesions originating from the pituitary stalk, are frequently associated with intraoperative and postoperative diabetes insipidus (DI). DI can lead to hypernatremia, and the rapid elevation of serum sodium within hours can precipitate acute brain tissue shrinkage, potentially resulting in devastating complications including intracerebral hemorrhage, cerebral venous sinus thrombosis, seizures, somnolence, and coma. Furthermore, dehydration secondary to DI may compromise organ perfusion and enhance anaerobic glycolysis in tissues, leading to hyperlactatemia and even lactic acidosis. However, the currently available evidence is insufficient to support the routine prophylactic anti-diuretic therapy during surgery.This study aims to evaluate the efficacy and safety of prophylactic low-dose continuous intravenous dDAVP infusion in patients undergoing surgery for complex sellar region lesions, with respect to reducing the incidence of hypernatremia occurring during surgery or within the first 24 hours postoperatively.
76 studies on the registry are indexed under Craniopharyngioma; 19 are open to participants now.
This study's planned enrollment of 152 is above the median of 40 across 49 interventional studies indexed under Craniopharyngioma.
Browse Craniopharyngioma studies →Zhaoyun Zhang is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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(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:
Estimated surgical duration > 4 hours. (3) Health status: Adequate organ function to tolerate surgery, and no to desmopressin (dDAVP) administration. (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:
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 to dDAVP or any of its . (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 drug must exceed 4 weeks.
(6) Any other conditions deemed unsuitable for participation in this study by the investigator's judgment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receiving prophylactic dDAVP treatment during surgery
Drug: Desmopressin (DDAVP)
Not receiving prophylactic dDAVP treatment
Other: Control
Desmopressin acetate (dDAVP) solution for injection, administered as a continuous intravenous infusion via syringe pump at a rate of 10mL/min (3.56 μg dDAVP diluted in 20ml normal saline)after Bony opening of the sella floor. The study intervention is compared to an equal volume of normal saline (0.9% NaCl) administered via the same route and regimen as placebo.
Not receiving prophylactic dDAVP treatment
Incidence of hypernatremia within the first 24 hours postoperatively
Incidence of hypernatremia (serum sodium \> 145 mmol/L) or use of rescue therapy for hypernatremia within the first 24 hours postoperatively
Time frame: Up to 24 hours postoperatively
Plan to share: Undecided
Started Jun 2026 (actual). Primary completion is estimated for May 2028, 22 months after the start.
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Zhaoyun Zhang