Vasopressin Causing Adverse Effects in Therapeutic UseNCT06422975
Registry of Patients in Shock Treated With Vasopressin
An observational study of Vasopressin Causing Adverse Effects in Therapeutic Use and Shock, run by Hospital Universitario 12 de Octubre at 24 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasopressin Causing Adverse Effects in Therapeutic Use, Shock, Vasopressor Adverse Reaction
- What is being tested?
- Vasopressin
- How many people
- 500 participants
- Where
- 24 sitesSpain
- Study dates
- 9 Jul 2024to Jun 2026
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in shock receiving vasopressin
Who may be able to join
- 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.
Who cannot join
- Non-consent by patient/legal representatives
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Spain24 sites, 24 recruiting
- Not yet recruiting
Hospital Universitario de A Coruña
A Coruña
Pablo Rama Maceiras
- Not yet recruiting
Hospital Universitario de Cruces
Barakaldo
Gontzal Tamayo
- Not yet recruiting
Hospital de Sant Pau
Barcelona
Marta Giné Servén
- Not yet recruiting
Hospital del Mar
Barcelona
Ramón Adalia
- Not yet recruiting
Hospital Universitario Valle de Hebrón
Barcelona
Miriam de Nadal
- Not yet recruiting
Hospital Universitario de Basurto
Bilbao
Felipe Ortega Palacios
- Not yet recruiting
Hospital de Donostia
Donostia / San Sebastian
Cristina García Fernández
- Not yet recruiting
Hospital General Universitario de Elche
Elche
Ana Pérez Carbonell
- Not yet recruiting
Hospital Universitario de Cabueñes
Gijón
Pablo Fernández Solano
- Not yet recruiting
Complejo Asistencial Universitario de León
León
Rafael González de Castro
- Recruiting
Hospital Lucus Augustus
Lugo
Lorena Mouritz
- Not yet recruiting
Hospital General Universitario Gregorio Marañón
Madrid
Carlos Alberto Calvo García
- Recruiting
Hospital Universitario 12 de Octubre
Madrid
Raquel García Álvarez, raquelgarciaalvarez@gmail.com
- Not yet recruiting
Hospital Universitario La Princesa
Madrid
Fernando Ramasco Rueda
Jesús Nieves Alonso
- Not yet recruiting
Hospital Universitario Ramón y Cajal
Madrid
Amal Azzam
- Not yet recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda
Reyes Iranzo
- Not yet recruiting
Complexo Hospitalario Universitario de Ourense
Ourense
Concepción Alonso
- Not yet recruiting
Hospital Universitario Central de Asturias
Oviedo
Beatriz Mancha Getino
- Not yet recruiting
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife
David Domínguez
- Not yet recruiting
Hospital Universitario Marqués de Valdecilla
Santander
Adriana Ixquic Reyes Echeverria
- Not yet recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela
Manuel Taboada
- Not yet recruiting
Hospital Universitario Joan XXIII
Tarragona
Diego Prendes Fernández
- Not yet recruiting
Hospital Clínico Universitario de Valencia
Valencia
Gerardo Aguilar
- Not yet recruiting
Hospital Universitari i Politècnic La Fe
Valencia
Miguel Ángel Rodenas
About this study
Official title: Prospective Multicentre Observational Study of Patients Treated With Vasopressin in Critical Care Units
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.
Read more
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.
Read the 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.
- Conditions
- Vasopressin Causing Adverse Effects in Therapeutic Use, Shock, Vasopressor Adverse Reaction, Vasopressin Deficiency
- Being tested
- Vasopressin
- Keywords
- Vasopressin, Shock
- Medical subject headings
- Shock, Diabetes Insipidus, Neurogenic, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasopressinDrug
Patients treated with vasopressin
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (12)
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)
Measured: Up to 7 days
Define the impact of starting AVP on noradrenaline dose
Define the impact of starting AVP on noradrenaline dose (microgram/kg/minute)
Measured: Up to 7 days
Define the impact of starting AVP on lactate level
Define the impact of starting AVP on lactate level (mmol/L)
Measured: Up to 7 days
Observe when AVP is discontinued and how
Describe number of participants what AVP is discontinued first and how (abruptly or progressively)
Measured: Up to 7 days
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.
Measured: Up to 7 days
Incidence of side effects
Describe the incidence of side effects, whether it is related to AVP dose and patients' comorbidities.
Measured: Up to 7 days
28-day all-cause mortality
Death on or before study day 28
Measured: 28 days
90-day all-cause mortality
Death on or before study day 90
Measured: 90 days
Incidence of new renal replacement therapy
New receipt of renal replacement therapy after onset of shock
Measured: From onset of shock until hospital discharge, an average of 2 weeks
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
Measured: 28 days
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.
Measured: 28 days
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start9 Jul 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Vasopressin Causing Adverse Effects in Therapeutic UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raquel García Álvarez, Principal investigator, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422975
- Sponsor's protocol ID
- VASOPRES REGISTRY
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38003863Treschan 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.
PubMed 16931995Dunser 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.
PubMed 16931974Ramasco 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.
PubMed 38392609Evans 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.
PubMed 34599691Sharshar 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.
PubMed 12794416Holmes 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.
PubMed 11555538Martin 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.
PubMed 26125087Russell 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.
PubMed 18305265Demiselle 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.
PubMed 31970567Gordon 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.
PubMed 19841897Hamzaoui 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.
PubMed 37510705Garcia 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.
PubMed 40383482
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentre Observational Study of Patients Treated With Vasopressin in Critical Care Units
- ClinicalTrials.gov ID
- NCT06422975
- Acronym / sponsor ID
- VASOPRES REGISTRY
- Conditions
- Vasopressin Causing Adverse Effects in Therapeutic Use, Shock, Vasopressor Adverse Reaction, Vasopressin Deficiency
- Keywords
- Vasopressin, Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in shock receiving vasopressin
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Non-consent by patient/legal representatives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VasopressinPatients treated with vasopressin | Drug | – |
Primary outcome
Characterise the clinical practice of vasopressin use in the context of shock in a multicentre observational study.
Time frame: 90 days
Describing the time sequence of vasopressin and/or noradrenaline use (what is initiated first) during shock
12 secondary outcomes
Assess what prompted the decision to initiate AVP
Time frame: Up to 7 days
Define the impact of starting AVP on noradrenaline dose
Time frame: Up to 7 days
Define the impact of starting AVP on lactate level
Time frame: Up to 7 days
Observe when AVP is discontinued and how
Time frame: Up to 7 days
Estimate the range of doses of AVP used
Time frame: Up to 7 days
Incidence of side effects
Time frame: Up to 7 days
28-day all-cause mortality
Time frame: 28 days
90-day all-cause mortality
Time frame: 90 days
Incidence of new renal replacement therapy
Time frame: From onset of shock until hospital discharge, an average of 2 weeks
Vasopressor-free days to day 28
Time frame: 28 days
Intensive care unit-free days to day 28
Time frame: 28 days
Hospital-free days to day 28
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Results publication: PubMed 38003863Garcia-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.
- Results publication: PubMed 16931995Treschan 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.
- Results publication: PubMed 16931974Dunser 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.
- Results publication: PubMed 38392609Ramasco 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.
- Results publication: PubMed 34599691Evans 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.
- Results publication: PubMed 12794416Sharshar 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.
- Results publication: PubMed 11555538Holmes 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.
- Results publication: PubMed 26125087Martin 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.
- Results publication: PubMed 18305265Russell 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.
- Results publication: PubMed 31970567Demiselle 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.
- Results publication: PubMed 19841897Gordon 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.
- Results publication: PubMed 37510705Hamzaoui 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raquel García Álvarez principal investigator
Hospital Universitario 12 de Octubre
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasopressin Causing Adverse Effects in Therapeutic Use and Shock, run by Hospital Universitario 12 de Octubre at 24 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raquel García Álvarez, MD (+34913908243, raquelgarciaalvarez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterise the clinical practice of vasopressin use in the context of shock in a multicentre observational study. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06422975, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.