Current partner codePEPTIDESDE
NCT07712328·Phase 4·INTERVENTIONAL

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

Status

Enrolling by invitation

Phase

Phase 4

Enrollment

152

Locations

1

Results

Not posted

Publications

12

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Desmopressin (DDAVP)

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.

OTHER

Control

Not receiving prophylactic dDAVP treatment

Timeline

From registration to results.

  1. First posted

    Jul 17, 2026

  2. Study start

    Jun 2, 2026

  3. Primary completion

    May 1, 2028

  4. Study completion

    Sep 1, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 17, 2026

Outcomes

What the study measures.

Primary outcomes

Incidence of hypernatremia within the first 24 hours postoperatively

Time frame · Up to 24 hours postoperatively

Incidence of hypernatremia (serum sodium \> 145 mmol/L) or use of rescue therapy for hypernatremia within the first 24 hours postoperatively

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Huashan Hospital

Shanghai, China

Publications

Results and literature.

PMID 41221987Davoudi 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.PMID 39830821Yu 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.PMID 33527610Sugiura 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.PMID 32800304Summers 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.PMID 23195688Hayakawa 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.PMID 23959584Takami 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.PMID 33159114Codd 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.PMID 35671519Li 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.PMID 2496905Trilok 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.PMID 30028528Graham 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.PMID 14557435Morin-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.PMID 38995891Colares 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.

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