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Circulatory ShockPhase 2/3VANCSIIINCT03483753

Vasopressin or Norepinephrine in Vasoplegic Shock After Non-cardiac Surgery

A Phase 2/3 study testing Vasopressin and Norepinephrine in people with Circulatory Shock and Non-cardiac Surgery, run by University of Sao Paulo.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The purpose of the present study is to evaluate the effect of vasopressin compared to norepinephrine on the clinical complications of patients with vasospastic shock after noncardiac surgeries. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Circulatory Shock, Non-cardiac Surgery
What is being tested?
Vasopressin and Norepinephrine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2019to 2 Oct 2023
Phase
Phase 2/3
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

Who may be able to join

  • Age greater than 18 years;
  • Patients undergoing high-risk non-cardiac surgery;
  • vasopressor need within 24 hours after surgery, defined as mean arterial pressure (MAP) <65 mmHg after volume resuscitation with at least 1 liter of crystalloid solution (Ringer's lactate) and maintaining a cardiac index> 2.2 ml / min / m²;
  • Signature of the informed consent form.

Who cannot join

  • Allergy to vasoactive drugs;
  • Previous use of vasopressor;
  • Gestation;
  • Presence of Raynaud's phenomenon, altered Allen's test, systemic sclerosis or vasospastic diathesis;
  • Severe hyponatremia (Na <130 mEq / L);
  • Acute mesenteric ischemia;
Show all 9Show fewer
  • Acute coronary syndrome;
  • Participation in another study;
  • Refusal to participate in the study.

About this study

Official title: Vasopressin or Norepinephrine in Vasoplegic Shock After Non-cardiac Surgery: a Randomized and Controlled Trial

The purpose of the present study is to evaluate the effect of vasopressin compared to norepinephrine on the clinical complications of patients with vasospastic shock after noncardiac surgeries.

Read the detailed description

The Systemic Inflammatory Response Syndrome (SIRS) is a common complication after non-cardiac surgery, impacting negatively on patient outcome and with high incidence rates. Vasoplegic syndrome is the most serious complication of SIRS and can happen after any type of surgery. The etiology of the vasoplegic syndrome has not yet been fully elucidated, but is known to occur more frequently in patients at high surgical risk, submitted to major surgeries, or in the presence of perioperative complications and patients with comorbidities. In this circumstance, the depletion of vasopressin stocks is described, which may contribute to the refractoriness of the shock and the lack of response to the catecholaminergic drugs. The standard treatment of perioperative vasoplegia has been adequate volume replacement and administration of vasopressors, with norepinephrine being the most commonly used. However, it is known that norepinephrine may have deleterious effects on the body and in 20% of patients with vasospastic shock it is ineffective. Previous studies have suggested benefits of adding vasopressin in refractory situations, especially in septic shock. Recently the VANCS study (Vasopressin or norepinephrine in the vasopregic shock after cardiac surgery: double-blind, controlled and randomized study) demonstrated superiority of vasopressin in the reversion of vasoplegic shock after cardiac surgery, as well as a lower incidence of renal insufficiency, atrial fibrillation and shorter hospitalization time. (Anesthesiology. 2017 Jan;126(1):85-93.)

Being tested
Vasopressin, Norepinephrine
Keywords
Vasopressin, Norepinephrine, Post-operative, Critical Care
Medical subject headings
Shock, Diabetes Insipidus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VasopressinDrug

    Also called Blinded Vasopressin

    Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement.

    Continuous infusion of the drug at doses ranging from 0.01 U / min to 0.06 U / min

  • NorepinephrineDrug

    Also called Blinded Norepinephrine

    Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement. Continuous infusion of the drug at doses ranging from 0.1 mcg / kg / min to 1.0 mcg / kg / min.

Study groups in NCT03483753
Study groupRoleWhat they receive
Vasopressin groupExperimentalBlinded vasopressin
Receives: Drug: Vasopressin
Norepinephrine groupActive comparatorBlinded norepinephrine
Receives: Drug: Norepinephrine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence between groups of a composite outcome of all-cause mortality, cardiovascular and renal complications after high-risk non-cardiac surgeries

    Cardiovascular complications include: stroke, acute myocardial infarction, cardiogenic shock, nonfatal myocardial injury, and ventricular or supraventricular arrhythmias.

    Renal complications: Acute renal failure with AKIN stage 1 or higher or renal support therapy.

    Measured: 30 days

Secondary outcomes (14)

  1. All-cause mortality

    mortality rate of any cause

    Measured: 30 days after randomization

  2. Acute myocardial infarction

    to compare between groups the incidence of acute myocardial infarction

    Measured: 30 days after randomization

  3. Cardiogenic shock

    to compare between groups the incidence of cardiogenic shock

    Measured: 30 days after randomization

  4. Ventricular and / or supraventricular arrhythmia

    to compare between groups the incidence of Ventricular and / or supraventricular arrhythmia

    Measured: 30 days

  5. Acute respiratory distress syndrome (ARDS)

    to compare between groups the incidence of Acute respiratory distress syndrome (ARDS)

    Measured: 30 days

  6. Stroke and transient ischemic attack

    to compare between groups the incidence of Stroke and transient ischemic attack

    Measured: 30 days

  7. Delirium

    to compare between groups the incidence of Delirium

    Measured: 30 days

  8. Acute renal failure (AKIN 1 or more)

    to compare between groups the incidence of Acute renal failure (AKIN 1 or more)

    Measured: 30 days

  9. Length of time in the Intensive Care Unit (ICU) and hospital

    Length of time in the Intensive Care Unit (ICU) and hospital

    Measured: 30 days

  10. Length of mechanical ventilation

    Length of mechanical ventilation

    Measured: 30 days

  11. Septic shock

    to compare between groups the incidence of septic shock

    Measured: 30 days

  12. hospital and ICU readmission rate

    hospital and ICU readmission rate

    Measured: 30 days

  13. Reoperation

    number of patients who required reoperation

    Measured: 30 days

  14. Incidence of severe adverse events

    to compare the incidence of severe adverse outcomes defined as mesenteric ischemia, digital ischemia, hyponatremia (Na<130mEq/L), myocardial infarction or stroke

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2018
  2. Study startJan 2019 (estimated)
  3. Primary completion2 Oct 2023
  4. Study completion2 Oct 2023

Why it stopped: no funding for the study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03483753
Sponsor's protocol ID
62586316.6.0000.0065
Acronym
VANCSIII
Status last verified
Oct 2023
First submitted
5 Feb 2018
Last updated
5 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Levin MA, Lin HM, Castillo JG, Adams DH, Reich DL, Fischer GW. Early on-cardiopulmonary bypass hypotension and other factors associated with vasoplegic syndrome. Circulation. 2009 Oct 27;120(17):1664-71. doi: 10.1161/CIRCULATIONAHA.108.814533. Epub 2009 Oct 12.

    PubMed 19822810

  • Landry DW, Oliver JA. The pathogenesis of vasodilatory shock. N Engl J Med. 2001 Aug 23;345(8):588-95. doi: 10.1056/NEJMra002709. No abstract available.

    PubMed 11529214

  • Gkisioti S, Mentzelopoulos SD. Vasogenic shock physiology. Open Access Emerg Med. 2011 Jan 6;3:1-6. doi: 10.2147/OAEM.S10388. eCollection 2011.

    PubMed 27147845

  • Teboul JL, Monnet X. Detecting volume responsiveness and unresponsiveness in intensive care unit patients: two different problems, only one solution. Crit Care. 2009;13(4):175. doi: 10.1186/cc7979. Epub 2009 Aug 10.

    PubMed 19678915

  • Brown SM, Lanspa MJ, Jones JP, Kuttler KG, Li Y, Carlson R, Miller RR 3rd, Hirshberg EL, Grissom CK, Morris AH. Survival after shock requiring high-dose vasopressor therapy. Chest. 2013 Mar;143(3):664-671. doi: 10.1378/chest.12-1106.

    PubMed 22911566

  • Morales D, Madigan J, Cullinane S, Chen J, Heath M, Oz M, Oliver JA, Landry DW. Reversal by vasopressin of intractable hypotension in the late phase of hemorrhagic shock. Circulation. 1999 Jul 20;100(3):226-9. doi: 10.1161/01.cir.100.3.226.

    PubMed 10411844

  • 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.

    PubMed 18305265

  • Russell JA. Vasopressin, Norepinephrine, and Vasodilatory Shock after Cardiac Surgery: Another "VASST" Difference? Anesthesiology. 2017 Jan;126(1):9-11. doi: 10.1097/ALN.0000000000001435. No abstract available.

    PubMed 27841820

  • Hajjar LA, Vincent JL, Barbosa Gomes Galas FR, Rhodes A, Landoni G, Osawa EA, Melo RR, Sundin MR, Grande SM, Gaiotto FA, Pomerantzeff PM, Dallan LO, Franco RA, Nakamura RE, Lisboa LA, de Almeida JP, Gerent AM, Souza DH, Gaiane MA, Fukushima JT, Park CL, Zambolim C, Rocha Ferreira GS, Strabelli TM, Fernandes FL, Camara L, Zeferino S, Santos VG, Piccioni MA, Jatene FB, Costa Auler JO Jr, Filho RK. Vasopressin versus Norepinephrine in Patients with Vasoplegic Shock after Cardiac Surgery: The VANCS Randomized Controlled Trial. Anesthesiology. 2017 Jan;126(1):85-93. doi: 10.1097/ALN.0000000000001434.

    PubMed 27841822

  • Takenaka K, Ogawa E, Wada H, Hirata T. Systemic inflammatory response syndrome and surgical stress in thoracic surgery. J Crit Care. 2006 Mar;21(1):48-53; discussion 53-5. doi: 10.1016/j.jcrc.2005.07.001.

    PubMed 16616623

  • Haga Y, Beppu T, Doi K, Nozawa F, Mugita N, Ikei S, Ogawa M. Systemic inflammatory response syndrome and organ dysfunction following gastrointestinal surgery. Crit Care Med. 1997 Dec;25(12):1994-2000. doi: 10.1097/00003246-199712000-00016.

    PubMed 9403749

  • Dubin A, Pozo MO, Casabella CA, Palizas F Jr, Murias G, Moseinco MC, Kanoore Edul VS, Palizas F, Estenssoro E, Ince C. Increasing arterial blood pressure with norepinephrine does not improve microcirculatory blood flow: a prospective study. Crit Care. 2009;13(3):R92. doi: 10.1186/cc7922. Epub 2009 Jun 17.

    PubMed 19534818

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Vasopressin and Norepinephrine in people with Circulatory Shock and Non-cardiac Surgery, run by University of Sao Paulo.

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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence between groups of a composite outcome of all-cause mortality, cardiovascular and renal complications after high-risk non-cardiac surgeries (time frame: 30 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 NCT03483753, which also lists 12 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 5 Oct 2023.

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