Non-cardiac Surgery Clinical Trial
— VANCSIIIOfficial title:
Vasopressin or Norepinephrine in Vasoplegic Shock After Non-cardiac Surgery: a Randomized and Controlled Trial
Verified date | October 2023 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2, 2023 |
Est. primary completion date | October 2, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Sao Paulo |
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. — View Citation
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. 200 — View Citation
Gkisioti S, Mentzelopoulos SD. Vasogenic shock physiology. Open Access Emerg Med. 2011 Jan 6;3:1-6. doi: 10.2147/OAEM.S10388. eCollection 2011. — View Citation
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. — View Citation
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, Z — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
30 days | |
Secondary | All-cause mortality | mortality rate of any cause | 30 days after randomization | |
Secondary | Acute myocardial infarction | to compare between groups the incidence of acute myocardial infarction | 30 days after randomization | |
Secondary | Cardiogenic shock | to compare between groups the incidence of cardiogenic shock | 30 days after randomization | |
Secondary | Ventricular and / or supraventricular arrhythmia | to compare between groups the incidence of Ventricular and / or supraventricular arrhythmia | 30 days | |
Secondary | Acute respiratory distress syndrome (ARDS) | to compare between groups the incidence of Acute respiratory distress syndrome (ARDS) | 30 days | |
Secondary | Stroke and transient ischemic attack | to compare between groups the incidence of Stroke and transient ischemic attack | 30 days | |
Secondary | Delirium | to compare between groups the incidence of Delirium | 30 days | |
Secondary | Acute renal failure (AKIN 1 or more) | to compare between groups the incidence of Acute renal failure (AKIN 1 or more) | 30 days | |
Secondary | Length of time in the Intensive Care Unit (ICU) and hospital | Length of time in the Intensive Care Unit (ICU) and hospital | 30 days | |
Secondary | Length of mechanical ventilation | Length of mechanical ventilation | 30 days | |
Secondary | Septic shock | to compare between groups the incidence of septic shock | 30 days | |
Secondary | hospital and ICU readmission rate | hospital and ICU readmission rate | 30 days | |
Secondary | Reoperation | number of patients who required reoperation | 30 days | |
Secondary | 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 | 30 days |
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