Vasopressin or norepinefrine in vasoplagic shock in non-cardiac surgery patients (vancs III)

• Grant number: 18/18233-5
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Effective date (Start): January 01, 2019
• Effective date (End): December 31, 2019
• Field of knowledge: Health Sciences - Medicine - Surgery
• Principal Investigator: Juliano Pinheiro de Almeida
• Grantee: Gladys Cherres Xavier Esteves
• Host Institution: Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira (ICESP). Coordenadoria de Serviços de Saúde (CSS). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil

Abstract

Vasoplegic syndrome is the most severe spectrum of the systemic inflammatory response syndrome (SIRS), because of its important complications such as multiple organ dysfunction and increased mortality, usually occurring in situations such as septic shock and postoperative large surgeries such as cardiac and noncardiac surgeries. The treatment of vasoplegic syndrome consists of volume replacement and administration of vasopressors, with norepinephrine being the drug of first choice. However, norepinephrine is ineffective in about 20% of patients with vasoplegic shock, resulting in refractory shock, organic dysfunction and death. Thus, the search for other agents that restore vascular tonus gains space and vasopressin stands out as a useful and effective alternative in the management of septic and vasoplegic shocks of other etiologies. Its use in vasoplegic syndrome has been evaluated by several clinical studies of great importance, but despite some positive results its use in the context of the vasoplegic syndrome developed in the postoperative period of non-cardiac surgeries has not yet been defined. Objectives: To compare the efficacy and safety of the use of vasopressin in comparison to norepinephrine in the treatment of vasoplegic syndrome developed in the postoperative period of noncardiac surgeries. Methods: This is a prospective, double-blind, randomized, multicenter clinical study that will include a population older than or equal to 18 years old undergoing high-risk non-cardiac surgery at the Intensive Care Units of the Instituto do Câncer of HC-FMUSP, in the Intensive Care Units of HC-FMUSP and in the Intensive Care Unit of Incor-HC-FMUSP in post-operative patients of non-cardiac surgeries, who evolve with need for vasopressor therapy in up to 24 hours after the end of surgery. Inclusion criteria: a) Age greater than 18 years; b) Patients undergoing high-risk non-cardiac surgery (as described above); c) Need of vasopressor within 24 hours after surgery, defined as MAP<65 mmHg after volume resuscitation with at least 1 liter of crystalloid solution (Ringer lactate) and maintaining a cardiac index>2.2 ml/min/m²; d) Signature of the free and informed consent term. Exclusion criteria: a) Allergy to one of vasoactive drugs; b) Previous use of vasopressor; c) Gestation; d) Presence of Raynaud's phenomenon, altered Allen's test, systemic sclerosis or vasospastic diathesis; e) Severe hyponatremia (Na<130 mEq/L); f) Acute mesenteric ischemia; g) Acute coronary syndrome; h) Participation in another study; i) Refusal to participate in the study. A total of 338 patients will be randomized to one of the two vasopressin agents, norepinephrine or vasopressin, family members, health professionals, investigators and evaluators who analyze the outcomes will also be submitted to "masking or blinding" and were not informed to which group the patients were allocated throughout the study. Randomized patients will be monitored daily during hospitalization up to the 30th day of hospitalization after the surgical procedure. In case of hospital discharge before this time, a telephone contact will be made on the 30th day to collect information on possible outcomes composed of mortality from any cause, cardiovascular and renal complications. The record sheet containing information about inclusion criteria, exclusion criteria, demographic data, baseline characteristics, intraoperative data, and outcomes will be completed for each patient. This information will be grouped into a database from which pre-specified analyzes and additional analyzes will be performed. An instrument for data collection will be created to assist in obtaining and organizing the information required by the study. The data will be analyzed statistically through the Statistical Package SPSS for Windows, version 18. The drugs will be donated by the BIOLAB laboratory. The same will have no knowledge regarding randomization and treatment of patients.