Registry of Patients in Shock Treated With Vasopressin

NCT06422975 | Recruiting FDA Drug

• 1 other identifier: VASOPRES REGISTRY
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 24

Brief Summary

Arginine-vasopressin (AVP) is a non-catecholaminergic hormone produced in the hypothalamus and released into the circulation via the neurohypophysis. It has different actions depending on the receptors through which it acts: V1 (vasoconstriction, platelet aggregation, efferent arteriole constriction of the renal glomerulus, glycogenolysis); V2 (water reabsorption, release of von Willebrand factor and factor VIII); V3 (increased cortisol and insulin). Septic shock is the most common cause of vasoplegic shock and its management includes control of the focus, early antibiotic therapy, volume resuscitation, vasopressor therapy, support of various organ dysfunctions, as well as monitoring and follow-up. The Surviving Sepsis Campaign (a global initiative to improve sepsis management) recommends noradrenaline as the first line of vasopressor therapy and early addition of AVP as a second line rather than further up-titration of noradrenaline when signs of hypoperfusion persist, through its action primarily on V1. The rationale for its use in septic shock would be:

• endogenous vasopressin deficiency present in septic shock;
• as a catecholamine-sparing strategy, reducing the side effects of catecholamines;
• its potential nephroprotective effect;
• its use should be early. The uncertainties surrounding the use of AVP in septic shock and other types of shock are many, hence the need for this registry.

Conditions

Vasopressin Causing Adverse Effects in Therapeutic Use; Shock; Vasopressor Adverse Reaction; Vasopressin Deficiency

Keywords

Vasopressin; Shock

Outcome Measures

Primary Outcomes (1)

• Characterise the clinical practice of vasopressin use in the context of shock in a multicentre observational study.

  Describing the time sequence of vasopressin and/or noradrenaline use (what is initiated first) during shock

  90 days

Secondary Outcomes (12)

• Assess what prompted the decision to initiate AVP

  Up to 7 days

• Define the impact of starting AVP on noradrenaline dose

  Up to 7 days

• Define the impact of starting AVP on lactate level

  Up to 7 days

• Observe when AVP is discontinued and how

  Up to 7 days

• Estimate the range of doses of AVP used

  Up to 7 days

Interventions

Vasopressin DRUG

Patients treated with vasopressin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in shock receiving vasopressin

You may qualify if:

• Any patient over 18 years of age who is in shock and requires the administration of vasoconstrictors, to whom vasopressin is administered in the operating theatre and/or critical care unit, according to best clinical practice.

You may not qualify if:

• Non-consent by patient/legal representatives

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead

Study Sites (24)

Hospital Universitario de A Coruña

A Coruña, Spain

NOT YET RECRUITING

Hospital Universitario de Cruces

Barakaldo, Spain

NOT YET RECRUITING

Hospital de Sant Pau

Barcelona, Spain

NOT YET RECRUITING

Hospital del Mar

Barcelona, Spain

NOT YET RECRUITING

Hospital Universitario Valle de Hebrón

Barcelona, Spain

NOT YET RECRUITING

Hospital Universitario de Basurto

Bilbao, Spain

NOT YET RECRUITING

Hospital de Donostia

Donostia / San Sebastian, Spain

NOT YET RECRUITING

Hospital General Universitario de Elche

Elche, Spain

NOT YET RECRUITING

Hospital Universitario de Cabueñes

Gijón, Spain

NOT YET RECRUITING

Complejo Asistencial Universitario de León

León, Spain

NOT YET RECRUITING

Hospital Lucus Augustus

Lugo, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, Spain

NOT YET RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Spain

RECRUITING

Hospital Universitario La Princesa

Madrid, Spain

NOT YET RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Spain

NOT YET RECRUITING

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain

NOT YET RECRUITING

Complexo Hospitalario Universitario de Ourense

Ourense, Spain

NOT YET RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Spain

NOT YET RECRUITING

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Spain

NOT YET RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Spain

NOT YET RECRUITING

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Spain

NOT YET RECRUITING

Hospital Universitario Joan XXIII

Tarragona, Spain

NOT YET RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, Spain

NOT YET RECRUITING

Hospital Universitari i Politècnic La Fe

Valencia, Spain

NOT YET RECRUITING

Related Publications (13)

• Garcia-Alvarez R, Arboleda-Salazar R. Vasopressin in Sepsis and Other Shock States: State of the Art. J Pers Med. 2023 Oct 29;13(11):1548. doi: 10.3390/jpm13111548.

  PMID: 38003863 RESULT

• Treschan TA, Peters J. The vasopressin system: physiology and clinical strategies. Anesthesiology. 2006 Sep;105(3):599-612; quiz 639-40. doi: 10.1097/00000542-200609000-00026.

  PMID: 16931995 RESULT

• Dunser MW, Lindner KH, Wenzel V. A century of arginine vasopressin research leading to new therapeutic strategies. Anesthesiology. 2006 Sep;105(3):444-5. doi: 10.1097/00000542-200609000-00004. No abstract available.

  PMID: 16931974 RESULT

• Ramasco F, Nieves-Alonso J, Garcia-Villabona E, Vallejo C, Kattan E, Mendez R. Challenges in Septic Shock: From New Hemodynamics to Blood Purification Therapies. J Pers Med. 2024 Feb 3;14(2):176. doi: 10.3390/jpm14020176.

  PMID: 38392609 RESULT

• Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.

  PMID: 34599691 RESULT

• Sharshar T, Blanchard A, Paillard M, Raphael JC, Gajdos P, Annane D. Circulating vasopressin levels in septic shock. Crit Care Med. 2003 Jun;31(6):1752-8. doi: 10.1097/01.CCM.0000063046.82359.4A.

  PMID: 12794416 RESULT

• Holmes CL, Patel BM, Russell JA, Walley KR. Physiology of vasopressin relevant to management of septic shock. Chest. 2001 Sep;120(3):989-1002. doi: 10.1378/chest.120.3.989.

  PMID: 11555538 RESULT

• Martin C, Medam S, Antonini F, Alingrin J, Haddam M, Hammad E, Meyssignac B, Vigne C, Zieleskiewicz L, Leone M. NOREPINEPHRINE: NOT TOO MUCH, TOO LONG. Shock. 2015 Oct;44(4):305-9. doi: 10.1097/SHK.0000000000000426.

  PMID: 26125087 RESULT

• Russell JA, Walley KR, Singer J, Gordon AC, Hebert PC, Cooper DJ, Holmes CL, Mehta S, Granton JT, Storms MM, Cook DJ, Presneill JJ, Ayers D; VASST Investigators. Vasopressin versus norepinephrine infusion in patients with septic shock. N Engl J Med. 2008 Feb 28;358(9):877-87. doi: 10.1056/NEJMoa067373.

  PMID: 18305265 RESULT

• Demiselle J, Fage N, Radermacher P, Asfar P. Vasopressin and its analogues in shock states: a review. Ann Intensive Care. 2020 Jan 22;10(1):9. doi: 10.1186/s13613-020-0628-2.

  PMID: 31970567 RESULT

• Gordon AC, Russell JA, Walley KR, Singer J, Ayers D, Storms MM, Holmes CL, Hebert PC, Cooper DJ, Mehta S, Granton JT, Cook DJ, Presneill JJ. The effects of vasopressin on acute kidney injury in septic shock. Intensive Care Med. 2010 Jan;36(1):83-91. doi: 10.1007/s00134-009-1687-x. Epub 2009 Oct 20.

  PMID: 19841897 RESULT

• Hamzaoui O, Goury A, Teboul JL. The Eight Unanswered and Answered Questions about the Use of Vasopressors in Septic Shock. J Clin Med. 2023 Jul 10;12(14):4589. doi: 10.3390/jcm12144589.

  PMID: 37510705 RESULT

• Garcia Alvarez R, Ramasco F, Nieves Alonso J, Mouriz L, Rama P, Bilbao I, Perez Carbonell A, Rodenas MA, Ortega F, Vives M, Calvo CA, Taboada M, Azzam A, Merino M, Martinez F, Dominguez D, de Llano CT, Adalia R, Aguilar G, Aldecoa C, Mancha B, Reyes A, Gine M, Prendes D, Garcia Fernande C, de la Calle I, Cendrero M, Martinez Lopez A, Herrero JJ, de la Torre I, Kattan E, Hernandez G. Prospective Multicenter Observational Study of Patients in Shock Treated with Vasopressin: VASOPRES Registry Study Protocol. Rev Esp Anestesiol Reanim (Engl Ed). 2025 Aug-Sep;72(7):501768. doi: 10.1016/j.redare.2025.501768. Epub 2025 May 16.

  PMID: 40383482 DERIVED

MeSH Terms

Conditions

Shock; Diabetes Insipidus, Neurogenic; Diabetes Insipidus

Interventions

Vasopressins

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Raquel García Álvarez

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raquel García Álvarez, MD

CONTACT

+34913908243; raquelgarciaalvarez@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 21, 2024
• Study Start: July 9, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 15, 2024

Record last verified: 2024-04

Locations

ES (24)