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Vasopressin or Norepinephrine in Vasoplegic Shock After Non-cardiac Surgery (VANCSIII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483753
Recruitment Status : Not yet recruiting
First Posted : March 30, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Tais Felix Szeles, University of Sao Paulo

Brief 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.

Condition or disease Intervention/treatment Phase
Circulatory Shock Non-cardiac Surgery Drug: Vasopressin Drug: Norepinephrine Phase 2 Phase 3

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.)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Vasopressin or Norepinephrine in Vasoplegic Shock After Non-cardiac Surgery: a Randomized and Controlled Trial
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Vasopressin group
Blinded vasopressin
Drug: 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

Other Name: Blinded Vasopressin

Active Comparator: Norepinephrine group
Blinded norepinephrine
Drug: 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.
Other Name: Blinded Norepinephrine




Primary Outcome Measures :
  1. 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 ]

    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.



Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 days after randomization ]
    mortality rate of any cause

  2. Acute myocardial infarction [ Time Frame: 30 days after randomization ]
    to compare between groups the incidence of acute myocardial infarction

  3. Cardiogenic shock [ Time Frame: 30 days after randomization ]
    to compare between groups the incidence of cardiogenic shock

  4. Ventricular and / or supraventricular arrhythmia [ Time Frame: 30 days ]
    to compare between groups the incidence of Ventricular and / or supraventricular arrhythmia

  5. Acute respiratory distress syndrome (ARDS) [ Time Frame: 30 days ]
    to compare between groups the incidence of Acute respiratory distress syndrome (ARDS)

  6. Stroke and transient ischemic attack [ Time Frame: 30 days ]
    to compare between groups the incidence of Stroke and transient ischemic attack

  7. Delirium [ Time Frame: 30 days ]
    to compare between groups the incidence of Delirium

  8. Acute renal failure (AKIN 1 or more) [ Time Frame: 30 days ]
    to compare between groups the incidence of Acute renal failure (AKIN 1 or more)

  9. Length of time in the Intensive Care Unit (ICU) and hospital [ Time Frame: 30 days ]
    Length of time in the Intensive Care Unit (ICU) and hospital

  10. Length of mechanical ventilation [ Time Frame: 30 days ]
    Length of mechanical ventilation

  11. Septic shock [ Time Frame: 30 days ]
    to compare between groups the incidence of septic shock

  12. hospital and ICU readmission rate [ Time Frame: 30 days ]
    hospital and ICU readmission rate

  13. Reoperation [ Time Frame: 30 days ]
    number of patients who required reoperation

  14. Incidence of severe adverse events [ Time Frame: 30 days ]
    to compare the incidence of severe adverse outcomes defined as mesenteric ischemia, digital ischemia, hyponatremia (Na<130mEq/L), myocardial infarction or stroke



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • Acute coronary syndrome;
  • Participation in another study;
  • Refusal to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483753


Contacts
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Contact: Tais F Szeles, MD +5519992859415 taisfelix@usp.br
Contact: Ludhmila A Hajjar, MD, PhD +55993194401 ludhmila@terra.com.br

Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Juliano P Almeida, MD, PhD University of Sao Paulo
Principal Investigator: Tais F Szeles, MD University of Sao Paulo

Publications of Results:
Other Publications:

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Responsible Party: Tais Felix Szeles, PhD student, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03483753    
Other Study ID Numbers: 62586316.6.0000.0065
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Tais Felix Szeles, University of Sao Paulo:
Vasopressin
Norepinephrine
Post-operative
Critical Care
Additional relevant MeSH terms:
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Shock
Pathologic Processes
Vasopressins
Arginine Vasopressin
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents