Prospective Multicentre Observational Study of Patients Treated With Vasopressin in Critical Care Units
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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of vasopressin and/or noradrenaline use; how long vasopressin is used; and which vasoconstrictor is more frequently withdrawn earlier: vasopressin or noradrenaline.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)
| Facility | City | Country | Status |
|---|
| 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 |
+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