Registry of Patients in Shock Treated With Vasopressin

NCT06422975 — Unknown, 500 participants, Hospital Universitario 12 de Octubre

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Prospective Multicentre Observational Study of Patients Treated With Vasopressin in Critical Care Units

RegistryNCT06422975
StatusUnknown
Study typeObservational
Enrollment500 (Estimated)
SponsorHospital Universitario 12 de Octubre (Other)
ConditionsVasopressin Causing Adverse Effects in Therapeutic Use, Shock, Vasopressor Adverse Reaction, Vasopressin Deficiency
InterventionsVasopressin (Drug)
Datesstart 2024-07-09, primary completion 2026-06-01 (estimated), completion 2026-06-01 (estimated), first posted 2024-05-21, last updated 2024-07-15
Locations24 sites in Spain

Related Papers Related Patents Related Grants Related Experts
All trials for Vasopressin Causing Adverse Effects in Therapeutic Use All trials for Shock All trials of Vasopressin

-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.

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+Detailed 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.

+Arms and interventions

  • Vasopressin (Drug): Patients treated with vasopressin

+Outcome measures

Primary outcomes

  • Characterise the clinical practice of vasopressin use in the context of shock in a multicentre observational study. [90 days]: Describing the time sequence of vasopressin and/or noradrenaline use (what is initiated first) during shock

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (24)

FacilityCityCountryStatus
Hospital Universitario de A CoruñaA CoruñaSpainNot yet recruiting
Hospital Universitario de CrucesBarakaldoSpainNot yet recruiting
Hospital de Sant PauBarcelonaSpainNot yet recruiting
Hospital del MarBarcelonaSpainNot yet recruiting
Hospital Universitario Valle de HebrónBarcelonaSpainNot yet recruiting
Hospital Universitario de BasurtoBilbaoSpainNot yet recruiting
Hospital de DonostiaDonostia / San SebastianSpainNot yet recruiting
Hospital General Universitario de ElcheElcheSpainNot yet recruiting
Hospital Universitario de CabueñesGijónSpainNot yet recruiting
Complejo Asistencial Universitario de LeónLeónSpainNot yet recruiting
Hospital Lucus AugustusLugoSpainRecruiting
Hospital General Universitario Gregorio MarañónMadridSpainNot yet recruiting
Hospital Universitario 12 de OctubreMadridSpainRecruiting
Hospital Universitario La PrincesaMadridSpainNot yet recruiting
Hospital Universitario Ramón y CajalMadridSpainNot yet recruiting
Hospital Universitario Puerta de Hierro MajadahondaMajadahondaSpainNot yet recruiting
Complexo Hospitalario Universitario de OurenseOurenseSpainNot yet recruiting
Hospital Universitario Central de AsturiasOviedoSpainNot yet recruiting
Hospital Universitario Nuestra Señora de CandelariaSanta Cruz de TenerifeSpainNot yet recruiting
Hospital Universitario Marqués de ValdecillaSantanderSpainNot yet recruiting
Hospital Clínico Universitario de SantiagoSantiago de CompostelaSpainNot yet recruiting
Hospital Universitario Joan XXIIITarragonaSpainNot yet recruiting
Hospital Clínico Universitario de ValenciaValenciaSpainNot yet recruiting
Hospital Universitari i Politècnic La FeValenciaSpainNot yet recruiting

+Publications

  • Results publication: 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
  • Results publication: 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
  • Results publication: 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
  • Results publication: 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
  • Results publication: 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
  • Results publication: 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
  • Results publication: 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
  • Results publication: 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
  • Results publication: 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
  • Results publication: 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
  • Results publication: 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
  • Results publication: 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
  • Results publication: 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

+Investigators

  • Raquel García Álvarez, Principal investigator, Hospital Universitario 12 de Octubre