Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
82 participants
INTERVENTIONAL
2025-10-01
2028-10-01
Brief Summary
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Detailed Description
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In 2021, a study was published comparing abrupt versus gradual vasopressin discontinuation. This was a retrospective observational study including 1,318 patients. Using ICU length of stay as the primary outcome, no significant difference was observed between groups (abrupt discontinuation: 7.9 days; gradual discontinuation: 7.3 days; p = 0.6). Similarly, there was no difference in the incidence of clinically significant hypotension (abrupt: 39.7%; gradual: 41.7%; p = 0.53). However, when stratifying patients based on whether catecholamine infusions were still ongoing at the time of vasopressin discontinuation, the results reversed in terms of ICU stay (abrupt: 9.2 days; gradual: 7.6 days), although this difference was not statistically significant (p = 0.24). In 2023, another retrospective observational study was published comparing abrupt versus gradual vasopressin withdrawal, including 74 patients. No difference was found in the incidence of clinically significant hypotension (abrupt: 57.1%; gradual: 52.3%; p = 0.68), nor in ICU length of stay. It is important to note, however, that in this cohort only patients who had already discontinued catecholamines prior to vasopressin withdrawal were included.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Titrated group
The titrated group will follow the vasopressin weaning protocol used in the DOVSS study (reduction of 0.01 U/min per hour).
Titrated weaning of vasopressin.
The titrated group will follow the vasopressin weaning protocol used in the DOVSS study (reduction of 0.01 U/min per hour).
Abrupt group
The abrupt group will discontinue the vasopressin infusion at the time of randomization, without dose titration.
Abrupt weaning of vasopressin.
The abrupt group will discontinue the vasopressin infusion at the time of randomization, without dose titration.
Interventions
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Titrated weaning of vasopressin.
The titrated group will follow the vasopressin weaning protocol used in the DOVSS study (reduction of 0.01 U/min per hour).
Abrupt weaning of vasopressin.
The abrupt group will discontinue the vasopressin infusion at the time of randomization, without dose titration.
Eligibility Criteria
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Inclusion Criteria
* Admitted to the Intensive Care Unit
* Patients with vasopressor dependent sepsis
* Receiving combined norepinephrine and vasopressin therapy
Exclusion Criteria
* Withdrawal/reduction of vasopressin associated with the initiation of adrenaline or any other vasopressor
18 Years
ALL
No
Sponsors
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Hospital Nossa Senhora da Conceicao
OTHER
Responsible Party
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Cássio Mallmann
Critical Care Physician, MS
Principal Investigators
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Cássio Mallmann, Critical Care Physician, MS
Role: PRINCIPAL_INVESTIGATOR
Hospital Nossa Senhora da Conceicao
Locations
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Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Rafael Barberena Moraes, Critical Care Physician, PhD
Role: CONTACT
References
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Murata J, Buckley M, Lehn J, Agarwal SK, Stevenson B, Martinez B, MacLaren R. Incidence of Hypotension Associated With Two Different Vasopressin Discontinuation Strategies in the Recovery Phase of Septic Shock. J Pharm Pract. 2023 Aug;36(4):830-838. doi: 10.1177/08971900221078270. Epub 2022 Mar 25.
Lam SW, Sacha GL, Duggal A, Reddy AJ, Bauer SR. Abrupt Discontinuation Versus Down-Titration of Vasopressin in Patients Recovering from Septic Shock. Shock. 2021 Feb 1;55(2):210-214. doi: 10.1097/SHK.0000000000001609.
Der-Nigoghossian C, Hammond DA, Ammar MA. Narrative Review of Controversies Involving Vasopressin Use in Septic Shock and Practical Considerations. Ann Pharmacother. 2020 Jul;54(7):706-714. doi: 10.1177/1060028020901521. Epub 2020 Jan 20.
Jeon K, Song JU, Chung CR, Yang JH, Suh GY. Incidence of hypotension according to the discontinuation order of vasopressors in the management of septic shock: a prospective randomized trial (DOVSS). Crit Care. 2018 May 21;22(1):131. doi: 10.1186/s13054-018-2034-9.
Sacha GL, Lam SW, Duggal A, Torbic H, Reddy AJ, Bauer SR. Hypotension Risk Based on Vasoactive Agent Discontinuation Order in Patients in the Recovery Phase of Septic Shock. Pharmacotherapy. 2018 Mar;38(3):319-326. doi: 10.1002/phar.2082. Epub 2018 Feb 8.
Hammond DA, Painter JT, Meena N. Incidence of Clinically Significant Hypotension Stratified by Vasopressin Duration. J Intensive Care Med. 2019 Jan;34(1):77-78. doi: 10.1177/0885066617745809. No abstract available.
Landry DW, Levin HR, Gallant EM, Ashton RC Jr, Seo S, D'Alessandro D, Oz MC, Oliver JA. Vasopressin deficiency contributes to the vasodilation of septic shock. Circulation. 1997 Mar 4;95(5):1122-5. doi: 10.1161/01.cir.95.5.1122.
Bissell BD, Magee C, Moran P, Bastin MLT, Flannery AH. Hemodynamic Instability Secondary to Vasopressin Withdrawal in Septic Shock. J Intensive Care Med. 2019 Sep;34(9):761-765. doi: 10.1177/0885066617716396. Epub 2017 Jul 28.
Bauer SR, Aloi JJ, Ahrens CL, Yeh JY, Culver DA, Reddy AJ. Discontinuation of vasopressin before norepinephrine increases the incidence of hypotension in patients recovering from septic shock: a retrospective cohort study. J Crit Care. 2010 Jun;25(2):362.e7-362.e11. doi: 10.1016/j.jcrc.2009.10.005.
De Backer D, Deutschman CS, Hellman J, Myatra SN, Ostermann M, Prescott HC, Talmor D, Antonelli M, Pontes Azevedo LC, Bauer SR, Kissoon N, Loeches IM, Nunnally M, Tissieres P, Vieillard-Baron A, Coopersmith CM; Surviving Sepsis Campaign Research Committee. Surviving Sepsis Campaign Research Priorities 2023. Crit Care Med. 2024 Feb 1;52(2):268-296. doi: 10.1097/CCM.0000000000006135. Epub 2024 Jan 19.
Teboul JL, Duranteau J, Russell JA. Intensive care medicine in 2050: vasopressors in sepsis. Intensive Care Med. 2018 Jul;44(7):1130-1132. doi: 10.1007/s00134-017-4909-7. Epub 2017 Aug 31. No abstract available.
Leone M, Einav S, Antonucci E, Depret F, Lakbar I, Martin-Loeches I, Wieruszewski PM, Myatra SN, Khanna AK. Multimodal strategy to counteract vasodilation in septic shock. Anaesth Crit Care Pain Med. 2023 Jun;42(3):101193. doi: 10.1016/j.accpm.2023.101193. Epub 2023 Jan 5.
Hammond DA, Rech MA, Daley MJ, Devlin JW, Hodge EK, Kooda KJ, Lat I, Personett HA, Roberts R, Sacha G, Stollings JL, Swanson JM, Bauer SR. Perceptions regarding vasopressin use and practices in septic shock, and cost containment strategies. J Am Coll Clin Pharm. 2019 Jun;2(3):257-267. doi: 10.1002/jac5.1079. Epub 2019 Jan 24.
Other Identifiers
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CAAE: 83246724.1.0000.5530
Identifier Type: -
Identifier Source: org_study_id
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