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      Terlipressin infusion for prevention of vasoplegic syndrome in patients treated with angiotensin II receptor antagonist undergoing coronary artery bypass graft surgery: a randomized controlled study

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          Abstract

          Background and objectives

          Preoperative use of renin angiotensin system antagonists has been considered an independent risk factor for development of vasoplegic syndrome. The aim of this study was to demonstrate efficacy of prophylactic terlipressin infusion for prevention of vasoplegic syndrome in patients treated with angiotensin receptor blocker undergoing coronary artery bypass graft surgery.

          Patients and methods

          One hundred patients on angiotensin II receptor antagonist [losartan] scheduled for coronary artery bypass surgery were enrolled into this prospective randomized controlled study. Anesthetic technique, surgical technique, and cardiopulmonary bypass management were standardized for all patients. With the start of rewarming, patients were randomized to receive either terlipressin infusion 1.3 μg.kg −1.hour −1, or normal saline infusion. Incidence of vasoplegic syndrome score was used as primary outcome. Hemodynamic parameters, inotropic score, and vasopressor dependency index were used as secondary outcome.

          Results

          Incidence of vasoplegic syndrome was significantly lower in terlipressin group compared to placebo group. Norepinephrine was required in 2 patients of terlipressin versus 15 patients of placebo group. Mean arterial blood pressure was significantly higher in terlipressin group compared to placebo group (81.7 ± 18.5 versus 69.3 ± 20.2 at 60 min after weaning from CBP). Cardiac index was significantly lower in terlipressin group compared to placebo group (2.52 ± 1.48 versus 3.2 ± 1.55). Systemic vascular resistance was significantly higher in terlipressin group compared to placebo group (2438.09 ± 735.13 versus 1575.05 ± 753.54). Inotropic score and vasopressor dependency index were significantly lower in terlipressin group compared to placebo group.

          Conclusion

          Prophylactic terlipressin infusion could prevent development of vasoplegic syndrome in patients treated with angiotensin II receptor antagonist undergoing coronary artery bypass graft surgery.

          Trial registration

          PACTR, PACTR201804003249274, Registered 25/03/2018—retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3249.

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          Most cited references29

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          Renin-angiotensin-aldosterone system blockade for cardiovascular diseases: current status.

          Terry K W Ma, Kevin K H Kam, Bryan P Yan … (2010)
          Activation of the renin-angiotensin-aldosterone system (RAAS) results in vasoconstriction, muscular (vascular and cardiac) hypertrophy and fibrosis. Established arterial stiffness and cardiac dysfunction are key factors contributing to subsequent cardiovascular and renal complications. Blockade of RAAS has been shown to be beneficial in patients with hypertension, acute myocardial infarction, chronic systolic heart failure, stroke and diabetic renal disease. An aggressive approach for more extensive RAAS blockade with combination of two commonly used RAAS blockers [ACE inhibitors (ACEIs) and angiotensin receptor blockers (ARBs)] yielded conflicting results in different patient populations. Combination therapy is also associated with more side effects, in particular hypotension, hyperkalaemia and renal impairment. Recently published ONTARGET study showed ACEI/ARB combination therapy was associated with more adverse effects without any increase in benefit. The Canadian Hypertension Education Program responded with a new warning: 'Do not use ACEI and ARB in combination'. However, the European Society of Cardiology in their updated heart failure treatment guidelines still recommended ACEI/ARB combo as a viable option. This apparent inconsistency among guidelines generates debate as to which approach of RAAS inhibition is the best. The current paper reviews the latest evidence of isolated ACEI or ARB use and their combination in cardiovascular diseases, and makes recommendations for their prescriptions in specific patient populations.
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            Continuous terlipressin versus vasopressin infusion in septic shock (TERLIVAP): a randomized, controlled pilot study

            Andrea Morelli, Christian Ertmer, Sebastian Rehberg … (2009)
            Introduction Recent clinical data suggest that early administration of vasopressin analogues may be advantageous compared to a last resort therapy. However, it is still unknown whether vasopressin and terlipressin are equally effective for hemodynamic support in septic shock. The aim of the present prospective, randomized, controlled pilot trial study was, therefore, to compare the impact of continuous infusions of either vasopressin or terlipressin, when given as first-line therapy in septic shock patients, on open-label norepinephrine requirements. Methods We enrolled septic shock patients (n = 45) with a mean arterial pressure below 65 mmHg despite adequate volume resuscitation. Patients were randomized to receive continuous infusions of either terlipressin (1.3 μg·kg-1·h-1), vasopressin (.03 U·min-1) or norepinephrine (15 μg·min-1; n = 15 per group). In all groups, open-label norepinephrine was added to achieve a mean arterial pressure between 65 and 75 mmHg, if necessary. Data from right heart and thermo-dye dilution catheterization, gastric tonometry, as well as laboratory variables of organ function were obtained at baseline, 12, 24, 36 and 48 hours after randomization. Differences within and between groups were analyzed using a two-way ANOVA for repeated measurements with group and time as factors. Time-independent variables were compared with one-way ANOVA. Results There were no differences among groups in terms of systemic and regional hemodynamics. Compared with infusion of .03 U of vasopressin or 15 μg·min-1 of norepinephrine, 1.3 μg·kg-1·h-1 of terlipressin allowed a marked reduction in catecholamine requirements (0.8 ± 1.3 and 1.2 ± 1.4 vs. 0.2 ± 0.4 μg·kg-1·min-1 at 48 hours; each P < 0.05) and was associated with less rebound hypotension (P < 0.05). At the end of the 48-hour intervention period, bilirubin concentrations were higher in the vasopressin and norepinephrine groups as compared with the terlipressin group (2.3 ± 2.8 and 2.8 ± 2.5 vs. 0.9 ± 0.3 mg·dL-1; each P < 0.05). A time-dependent decrease in platelet count was only observed in the terlipressin group (P < 0.001 48 hours vs. BL). Conclusions The present study provides evidence that continuous infusion of low-dose terlipressin – when given as first-line vasopressor agent in septic shock – is effective in reversing sepsis-induced arterial hypotension and in reducing norepinephrine requirements. Trial registration ClinicalTrial.gov NCT00481572.
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              Vasoplegia during cardiac surgery: current concepts and management.

              Mikhail Levin, Justin Fischer (2009)
              Vasoplegic syndrome (VS) is a recognized and relatively common complication of cardiopulmonary bypass (CPB), appearing with an incidence ranging between 5% and 25%. It is characterized by significant hypotension, high or normal cardiac outputs and low systemic vascular resistance (SVR), and increased requirements for fluids and vasopressors during or after CPB. Patients developing VS are at increased risk for death and other major complications following cardiac surgery. This review will focus on the pathophysiology and contemporary strategies of treating VS encountered after CPB. Copyright © 2010 Elsevier Inc. All rights reserved.
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                Author and article information

                Contributors
                Mohamed Saleh: drsalehm2002@hotmail.com
                Sherine Kamal Zaki Kodeira: sherinekodeira1@yahoo.com
                Abdelkhalek Abdelmoneim Aboulseoud: aaaboulseoud@yahoo.co.uk
                Journal
                Journal ID (iso-abbrev): Ain-Shams J Anesthesiol
                Title: Ain-Shams Journal of Anesthesiology
                Publisher: Springer Berlin Heidelberg (Berlin/Heidelberg )
                ISSN (Electronic): 2090-925X
                Publication date (Electronic): 18 February 2020
                Publication date PMC-release: 18 February 2020
                Publication date (Print): 2020
                Volume: 12
                Issue: 1
                Electronic Location Identifier: 5
                Affiliations
                GRID grid.7269.a, ISNI 0000 0004 0621 1570, Department of Anesthesiology, Intensive Care, and Pain Management, Faculty of Medicine, , Ain Shams University, ; Cairo, Egypt
                Article
                Publisher ID: 54
                DOI: 10.1186/s42077-020-0054-6
                PMC ID: 7296192
                SO-VID: f3f4f15d-7727-4efd-8247-fe3526ca603a
                Copyright © © The Author(s) 2020
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

                History
                Date received : 6 October 2019
                Date accepted : 26 January 2020
                Categories
                Subject: Original Article
                Custom metadata
                issue-copyright-statement © The Author(s) 2020

                Keywords: terlipressin,vasoplegic syndrome,angiotensin ii receptor antagonist,coronary artery bypass graft surgery
                Data availability:
                Keywords: terlipressin, vasoplegic syndrome, angiotensin ii receptor antagonist, coronary artery bypass graft surgery

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