Vasopressin Versus Norepinephrine for the Management of Shock After Cardiac Surgery (VaNCS)

Vasoplegic syndrome after cardiac surgery is a common complication after cardiac surgery, with negative impact on patient outcomes and hospital costs. Pathogenesis of vasodilatory phenomenon after cardiac surgery remains a matter of controversy. Loss of vascular tone can be partly explained by the depletion of neurohypophyseal arginine vasopressin stores. The investigators hypothesized that the use of arginine vasopressin would be more effective on treatment of shock after cardiac surgery than norepinephrine, decreasing the composite end point of mortality and severe morbidity.

Study Overview

• Status: Unknown
• Conditions: Shock
• Intervention / Treatment: Drug: Norepinephrine; Drug: Vasopressin

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ludhmila Hajjar, MD, PhD; Phone Number: 55-11-93194401; Email: ludhmila@usp.br

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-000
    • Recruiting
    • Instituto do Coracao
    • Contact: Ludhmila Hajjar, MD, PhD; Phone Number: 55-11-93194401; Email: ludhmila@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• need vasopressor support

Exclusion Criteria:

• younger than 18 years;
• surgery without cardiopulmonary bypass;
• emergency procedure;
• ascending and descending thoracic aortic procedures;
• left ventricular aneurysm resection; enrollment in another study;
• pregnancy;
• neoplasm;
• Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis;
• severe hyponatremia (Na<130mEq/L);
• acute mesenteric ischemia;
• acute myocardial infarction;
• cardiogenic shock; and refusal to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
Active Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite endpoint of major morbidity according to Society of Thoracic Surgery	The primary end point is major morbidity according to STS (30-days mortality, mechanical ventilation > 48 hours, mediastinitis, surgical reexploration, stroke, acute renal failure)	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic effects	the time to attainment of hemodynamic stability ; the changes in hemodynamic variables; and the use of dobutamine or other inotropic agents.	28 days
occurence of adverse events and safety	Adverse events were categorized as arrhythmias, myocardial necrosis, skin necrosis, ischemia in limbs or distal extremities, or secondary infections	28 days
Time on mechanical ventilation	Days on mechanical ventilation during 30-days after surgery.	30 days
Incidence of infecction	Incidence of new infecction, sepsis, severe sepsis or septic shock in 30 days after surgery.	30-days
Length of ICU and Hospital stay	Compare between groups the period of time (days) that patients were in ICU and in Hospital.	90 days

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Publications and helpful links

General Publications

• O'Callaghan DJ, Gordon AC. What's new in vasopressin? Intensive Care Med. 2015 Dec;41(12):2177-9. doi: 10.1007/s00134-015-3849-3. Epub 2015 May 7. No abstract available.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): February 1, 2013
• Study Completion (Anticipated): May 1, 2013

Study Registration Dates

• First Submitted: January 2, 2012
• First Submitted That Met QC Criteria: January 5, 2012
• First Posted (Estimate): January 6, 2012

Study Record Updates

• Last Update Posted (Estimate): February 12, 2013
• Last Update Submitted That Met QC Criteria: February 11, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: cardiac surgery; Shock; norepinephrine; vasopressin
• Additional Relevant MeSH Terms: Pathologic Processes; Shock; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Natriuretic Agents; Hemostatics; Coagulants; Sympathomimetics; Vasoconstrictor Agents; Antidiuretic Agents; Norepinephrine; Vasopressins; Arginine Vasopressin
• Other Study ID Numbers: 0352/08