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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03483753
Other study ID # 62586316.6.0000.0065
Secondary ID
Status Withdrawn
Phase Phase 2/Phase 3
First received
Last updated
Start date January 2019
Est. completion date October 2, 2023

Study information

Verified date October 2023
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.)


Recruitment information / eligibility

Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

References & Publications (12)

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 allClick here to view all references

Outcome

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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