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CraniopharyngiomasPhase 4RCT-PIDSTNCT07712328

Randomized Controlled Clinical Study on the Prophylactic Intraoperative Use of Desmopressin in Complex Sellar Region Tumors

A Phase 4 study testing Desmopressin (DDAVP) in people with Craniopharyngiomas and Pituitary Macroadenoma, run by Zhaoyun Zhang at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Craniopharyngiomas and giant invasive pituitary adenomas, with lesions originating from the pituitary stalk, are frequently associated with intraoperative and postoperative diabetes insipidus (DI). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Desmopressin (DDAVP)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
152 participants
Where
1 siteChina
Study dates
2 Jun 2026to 1 Sep 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (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:
  • Preoperatively confirmed central diabetes insipidus (CDI);
  • Maximum tumor diameter > 3 cm with imaging evidence of suprasellar extension;
  • Imaging evidence of close anatomical relationship with the pituitary stalk, posterior pituitary, or hypothalamus, including compression, encasement, or invasion;
  • 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.
  • 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

Who cannot join

  • (1) Patients with pre-existing comorbidities affecting water and salt metabolism, including but not limited to:
  • Renal insufficiency (dDAVP is predominantly excreted unchanged by the kidneys; renal impairment may significantly prolong its half-life and increase the risk of hyponatremia);
  • Cardiac insufficiency (dDAVP-induced water and sodium retention may increase circulating blood volume and potentially precipitate heart failure);
  • Untreated adrenal insufficiency (cortisol deficiency impairs free water excretion);
  • 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.
  • 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.
  • Any other conditions deemed unsuitable for participation in this study by the investigator's judgment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Huashan Hospital

    Shanghai

Other trials in China

About this study

Official title: A Randomized, Controlled, Open-Label Clinical Trial of Prophylactic Intraoperative Desmopressin (dDAVP) in Patients Undergoing Surgery for Complex Sellar Region Tumors

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.

Being tested
Desmopressin (DDAVP), Control
Medical subject headings
Craniopharyngioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Desmopressin (DDAVP)Drug

    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.

  • ControlOther

    Not receiving prophylactic dDAVP treatment

Study groups in NCT07712328
Study groupRoleWhat they receive
Intervention groupExperimentalReceiving prophylactic dDAVP treatment during surgery
Receives: Drug: Desmopressin (DDAVP)
Control groupPlacebo comparatorNot receiving prophylactic dDAVP treatment
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2026
  2. Study start2 Jun 2026
  3. Primary completion1 May 2028 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
152 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07712328
Sponsor's protocol ID
KY2026-753
Acronym
RCT-PIDST
Status last verified
Jul 2026
First submitted
14 Jul 2026
Last updated
17 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Davoudi Z, Shahriari S, Rezaei O, Amirdosara M, Vakili K, Zangi M, Samadian M, Haghighimorad M, Ebrahimzade K, Mousavinejad SA, Sayehmiri F, Hallajnejad M, Sharifi G. Incidence and risk factors for transient and permanent central diabetes insipidus following pituitary adenoma surgery: a single center study. Int J Neurosci. 2026 Apr;136(4):417-425. doi: 10.1080/00207454.2025.2564646. Epub 2025 Nov 12.

    PubMed 41221987

  • Yu Z, Swenson K, Graber E. Prospective Pilot Evaluation of the Safety, Tolerability, and Efficacy of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel plus Clascoterone 1% Cream in Adult Patients with Acne. J Clin Aesthet Dermatol. 2025 Jan;18(1):20-23.

    PubMed 39830821

  • Sugiura A, Weber M, Tabata N, Goto T, Ozturk C, Lin M, Zimmer S, Nickenig G, Sinning JM. QRS duration is a risk indicator of adverse outcomes after MitraClip. Catheter Cardiovasc Interv. 2021 Oct;98(4):E594-E601. doi: 10.1002/ccd.29505. Epub 2021 Feb 1.

    PubMed 33527610

  • Summers BJ, Wilver NL, Garratt GH, Cougle JR. A Multimethod Analysis of Incompleteness and Visual "Not Just Right" Experiences in Body Dysmorphic Disorder. Behav Ther. 2020 Sep;51(5):764-773. doi: 10.1016/j.beth.2019.11.001. Epub 2019 Nov 26.

    PubMed 32800304

  • Hayakawa S, Matsumura H, Nakamura N, Yohda M, Ohno H. Spectroscopic characterization of the acid-alkaline transition of a thermophilic cytochrome P450. FEBS Lett. 2013 Jan 4;587(1):94-7. doi: 10.1016/j.febslet.2012.11.017. Epub 2012 Nov 27.

    PubMed 23195688

  • Takami A. Guest editorial: new basic and clinical aspects of graft-versus-host disease: what can we do without ''Doc'' Brown's help? Int J Hematol. 2013 Sep;98(3):273-4. doi: 10.1007/s12185-013-1417-6. No abstract available.

    PubMed 23959584

  • Codd LN, Blackmore DG, Vukovic J, Bartlett PF. Exercise reverses learning deficits induced by hippocampal injury by promoting neurogenesis. Sci Rep. 2020 Nov 6;10(1):19269. doi: 10.1038/s41598-020-76176-1.

    PubMed 33159114

  • Li X, Chen C, Zhang T, Ding N, Zheng P, Yang M. Comparative pharmacokinetic studies of five C-glycosylflavones in normal and urolithiasis model rats following administration of total flavonoids from Desmodium styracifolium by liquid chromatography-tandem mass spectrometry. J Sep Sci. 2022 Aug;45(15):2901-2913. doi: 10.1002/jssc.202200010. Epub 2022 Jun 25.

    PubMed 35671519

  • Trilok G, Draper HH. Effect of a high protein intake on acid-base balance in adult rats. Calcif Tissue Int. 1989 May;44(5):339-42. doi: 10.1007/BF02556314.

    PubMed 2496905

  • Graham ZA, Harlow L, Bauman WA, Cardozo CP. Alterations in mitochondrial fission, fusion, and mitophagic protein expression in the gastrocnemius of mice after a sciatic nerve transection. Muscle Nerve. 2018 Oct;58(4):592-599. doi: 10.1002/mus.26197. Epub 2018 Sep 3.

    PubMed 30028528

  • Morin-Papunen L, Rautio K, Ruokonen A, Hedberg P, Puukka M, Tapanainen JS. Metformin reduces serum C-reactive protein levels in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2003 Oct;88(10):4649-54. doi: 10.1210/jc.2002-021688.

    PubMed 14557435

  • Colares L, Lopes-Neto RB, Siqueira AS, Leao CF, Castro AF, Dunck B. Functional diversity in human song. PLoS One. 2024 Jul 12;19(7):e0307032. doi: 10.1371/journal.pone.0307032. eCollection 2024.

    PubMed 38995891

  • Kumrawat A, Gupta S, Dhillon HS, Kumrawat P. Prognostic Value of Admission Lactate Levels in Critically Ill Patients: A Comparative Study With Sequential Organ Failure Assessment and Acute Physiology and Chronic Health Evaluation II Scores. Cureus. 2024 Oct 13;16(10):e71372. doi: 10.7759/cureus.71372. eCollection 2024 Oct.

    PubMed 39539913

  • Novitskaya MG, DeRosa PA, Chen DT, Khalil A, Harfouch O, O'Connor EE, Schmalzle SA. Rapidly Enlarging Parotid Mass in a Person Living with HIV: A Case of Multiple Myeloma with Extramedullary Plasmacytoma. Am J Case Rep. 2023 Aug 3;24:e938431. doi: 10.12659/AJCR.938431.

    PubMed 37533236

  • Lipshultz SE, Franco VI, Miller TL, Colan SD, Sallan SE. Cardiovascular disease in adult survivors of childhood cancer. Annu Rev Med. 2015;66:161-76. doi: 10.1146/annurev-med-070213-054849.

    PubMed 25587648

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Desmopressin (DDAVP) in people with Craniopharyngiomas and Pituitary Macroadenoma, run by Zhaoyun Zhang 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 6 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 17 Jul 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of hypernatremia within the first 24 hours postoperatively (time frame: Up to 24 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07712328, which also lists 23 linked publications.

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 17 Jul 2026.

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