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

Summary

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.

Timeline

Start

2026-06-02

Primary completion

2028-05-01

Completion

2028-09-01

Publications

• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results Edate S, Albanese A. Management of electrolyte and fluid disorders after brain surgery for pituitary/suprasellar tumours. Horm Res Paediatr. 2015;83(5):293-301. doi: 10.1159/000370065. Epub 2015 Feb 11.
• Results Kamel KS, Schreiber M, Harel Z. Hypernatremia. JAMA. 2022 Feb 22;327(8):774-775. doi: 10.1001/jama.2022.1376. No abstract available.
• Results Giraldi EA, Ioachimescu AG. Postoperative Considerations Following Pituitary Surgery: A Guide for Clinicians. Endocr Pract. 2025 Oct;31(10):1339-1345. doi: 10.1016/j.eprac.2025.06.018. Epub 2025 Jun 26.
• Results Burke WT, Cote DJ, Penn DL, Iuliano S, McMillen K, Laws ER. Diabetes Insipidus After Endoscopic Transsphenoidal Surgery. Neurosurgery. 2020 Oct 15;87(5):949-955. doi: 10.1093/neuros/nyaa148.
• Results Joshi RS, Pereira MP, Osorio RC, Oh T, Haddad AF, Pereira KM, Donohue KC, Peeran Z, Sudhir S, Jain S, Beniwal A, Chandra A, Han SJ, Rolston JD, Theodosopoulos PV, Kunwar S, Blevins LS, Aghi MK. Identifying risk factors for postoperative diabetes insipidus in more than 2500 patients undergoing transsphenoidal surgery: a single-institution experience. J Neurosurg. 2022 Jan 28;137(3):647-657. doi: 10.3171/2021.11.JNS211260. Print 2022 Sep 1.
• Results Nemergut EC, Zuo Z, Jane JA Jr, Laws ER Jr. Predictors of diabetes insipidus after transsphenoidal surgery: a review of 881 patients. J Neurosurg. 2005 Sep;103(3):448-54. doi: 10.3171/jns.2005.103.3.0448.
• Results Spiess M, Beuret N, Rutishauser J. Genetic forms of neurohypophyseal diabetes insipidus. Best Pract Res Clin Endocrinol Metab. 2020 Sep;34(5):101432. doi: 10.1016/j.beem.2020.101432. Epub 2020 Jun 19.
• Results Verbalis JG. Acquired forms of central diabetes insipidus: Mechanisms of disease. Best Pract Res Clin Endocrinol Metab. 2020 Sep;34(5):101449. doi: 10.1016/j.beem.2020.101449. Epub 2020 Jul 10.

Drugs

Indications