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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06422975
Other study ID # VASOPRES REGISTRY
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date June 2026

Study information

Verified date April 2024
Source Hospital Universitario 12 de Octubre
Contact Raquel García Álvarez, MD
Phone +34913908243
Email raquelgarciaalvarez@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

The main objective is to characterise the routine clinical practice of vasopressin use in the context of shock in a multicentre observational study. By collecting clinical, analytical and echocardiographic data in a uniform manner, describing the time sequence of vasopressin and/or noradrenaline use; how long vasopressin is used; and which vasoconstrictor is more frequently withdrawn earlier: vasopressin or noradrenaline. The secondary objectives are: - to assess what motivated the decision to initiate AVP: type of shock, perfusion parameters, noradrenaline dose; - to define the impact of initiating AVP on noradrenaline dose (whether the dose can be reduced or not), on cardiac function (whether echocardiographic data improve or worsen) and on perfusion data (whether laboratory and clinical data such as lactate, capillary refill time, mottling score or diuresis improve or worsen); - estimate what is the dose range of AVP used and what is the maximum dose used in routine clinical practice; - observe when AVP is stopped, how (abruptly or progressively); - describe the incidence of side effects of AVP, whether it is related to the dose of AVP and the comorbidities of the patients; - assess medium/long-term outcomes: 28- and 90-day mortality, ICU and hospital stay, days of vasopressor support, days of mechanical ventilation, days of renal replacement.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date June 2026
Est. primary completion date June 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Non-consent by patient/legal representatives

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vasopressin
Patients treated with vasopressin

Locations

Country Name City State
Spain Hospital Universitario de A Coruña A Coruña
Spain Hospital Universitario de Cruces Baracaldo
Spain Hospital de Sant Pau Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital Universitario Valle de Hebrón Barcelona
Spain Hospital Universitario de Basurto Bilbao
Spain Hospital de Donostia Donostia
Spain Hospital General Universitario de Elche Elche
Spain Hospital Universitario de Cabueñes Gijón
Spain Complejo Asistencial Universitario de León León
Spain Hospital Lucus Augustus Lugo
Spain Hospital General Universitario Gregorio Marañón Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario La Princesa Madrid
Spain Hospital Universitario Ramón y Cajal Madrid
Spain Hospital Universitario Puerta de Hierro Majadahonda Majadahonda
Spain Complexo Hospitalario Universitario de Ourense Ourense
Spain Hospital Universitario Central de Asturias Oviedo
Spain Hospital Universitario Nuestra Señora de Candelaria Santa Cruz De Tenerife
Spain Hospital Universitario Marqués de Valdecilla Santander
Spain Hospital Clínico Universitario de Santiago Santiago De Compostela
Spain Hospital Universitario Joan XXIII Tarragona
Spain Hospital Clínico Universitario de Valencia Valencia
Spain Hospital Universitari i Politècnic La Fe Valencia

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitario 12 de Octubre

Country where clinical trial is conducted

Spain, 

References & Publications (12)

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. — View Citation

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. — View Citation

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, Ce — View Citation

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. — View Citation

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: — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Assess what prompted the decision to initiate AVP Assess what prompted the decision to initiate AVP: type of shock (vasoplegic, hypovolemic,...), perfusion parameters (as lactate) or noradrenaline dose (microgram/kg/minute) Up to 7 days
Secondary Define the impact of starting AVP on noradrenaline dose Define the impact of starting AVP on noradrenaline dose (microgram/kg/minute) Up to 7 days
Secondary Define the impact of starting AVP on lactate level Define the impact of starting AVP on lactate level (mmol/L) Up to 7 days
Secondary Observe when AVP is discontinued and how Describe number of participants what AVP is discontinued first and how (abruptly or progressively) Up to 7 days
Secondary Estimate the range of doses of AVP used Estimate the range of doses of AVP used and the maximum dose used in routine clinical practice. Up to 7 days
Secondary Incidence of side effects Describe the incidence of side effects, whether it is related to AVP dose and patients' comorbidities. Up to 7 days
Secondary 28-day all-cause mortality Death on or before study day 28 28 days
Secondary 90-day all-cause mortality Death on or before study day 90 90 days
Secondary Incidence of new renal replacement therapy New receipt of renal replacement therapy after onset of shock From onset of shock until hospital discharge, an average of 2 weeks
Secondary Vasopressor-free days to day 28 Number of days between day 28 and the end of the last period of vasopressor therapy prior to day 28 28 days
Secondary Intensive care unit-free days to day 28 Number of days between day 28 and the end of the last period of intensive care unit admission prior to day 28. 28 days
Secondary Hospital-free days to day 28 Number of days between day 28 and the end of the last period of hospital admission prior to day 28 28 days
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