scholarly journals Optimal VAsopressor TitraTION in patients 65 years and older (OVATION-65): protocol and statistical analysis plan for a randomised clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e037947
Author(s):  
Marie-Hélène Masse ◽  
Marie-Claude Battista ◽  
Mary Elizabeth Wilcox ◽  
Ruxandra Pinto ◽  
Nicole Marinoff ◽  
...  
Keyword(s):  
Cognitive Function ◽  
Usual Care ◽  
Life Support ◽  
Troponin T ◽  
Extracorporeal Life Support ◽  
Eligible Patient ◽  
Randomised Trial ◽  
Organ Injury ◽  
Resource Utilisation ◽  
Permissive Hypotension

IntroductionVasodilatory hypotension is common among intensive care unit (ICU) patients; vasopressors are considered standard of care. However, optimal mean arterial pressure (MAP) targets for vasopressor titration are unknown. The objective of the Optimal VAsopressor TitraTION in patients 65 years and older (OVATION-65) trial is to ascertain the effect of permissive hypotension (vasopressor titration to achieve MAP 60–65 mm Hg) versus usual care on biomarkers of organ injury in hypotensive patients aged ≥65 years.Methods and analysisOVATION-65 is an allocation-concealed randomised trial in 7 Canadian hospitals. Eligible patients are ≥65 years of age, in an ICU with vasodilatory hypotension, receiving vasopressors for ≤12 hours to maintain MAP ≥65 mm Hg during or after adequate fluid resuscitation, and expected to receive vasopressors for ≥6 additional hours. Patients are excluded for any of the following: active treatment for spinal cord or acute brain injury; vasopressors given solely for bleeding, ventricular failure or postcardiopulmonary bypass vasoplegia; withdrawal of life-sustaining treatments expected within 48 hours; death perceived as imminent; previous enrolment in OVATION-65; organ transplant within the last year; receiving extracorporeal life support or lack of physician equipoise. Patients are randomised to permissive hypotension versus usual care for up to 28 days. The primary outcome is high-sensitivity troponin T, a biomarker of cardiac injury, on day 3. Secondary outcomes include biomarkers of injury to other organs (brain, liver, intestine, skeletal muscle); lactate (a biomarker of global tissue dysoxia); resource utilisation; adverse events; mortality (90 days and 6 months) and cognitive function (6 months). Assessors of biomarkers, mortality and cognitive function are blinded to allocation.Ethics and disseminationThis protocol has been approved at all sites. Consent is obtained from the eligible patient, the substitute decision-maker if the patient is incapable, or in a deferred fashion where permitted. End-of-grant dissemination plans include presentations, publications and social media platforms and discussion forums.Trial registration numberNCT03431181.

PD18 Cost-Effectiveness Of Extracorporeal Life Support In Cardiogenic Shock

2018 ◽  
Vol 34 (S1) ◽  
pp. 136-136
Author(s):  
Eduardo Bertoldi ◽  
Carisi Polanczyk ◽  
Luciane Cruz ◽  
Ana Etges ◽  
Liane Cardoso ◽  
...  
Keyword(s):  
Public Health ◽  
Cost Effectiveness ◽  
Cardiogenic Shock ◽  
Usual Care ◽  
Life Support ◽  
Public Health System ◽  
Extracorporeal Life Support ◽  
Gdp Per Capita ◽  
Hospital Death ◽  
Per Capita

Introduction:Venoarterial extracorporeal life support (ECLS) is increasingly used in patients during cardiogenic shock, due to favorable results in this very high-risk scenario. However, it is a costly intervention that requires heavy financial investment and specialized human resources.Methods:Cost-effectiveness analysis to evaluate ECLS in the perspective of the Brazilian public health system (SUS) in the population of adult patients with cardiogenic shock. A decision tree comparing ECLS and usual care was built, using efficacy data from a systematic review of literature, and cost data from SUS reimbursement values. Impact of parameter variability and uncertainty were ascertained with deterministic and probabilistic sensitivity analysis.Results:Usual care resulted in thirty percent probability of survival, at an average cost of 3,000 international dollars (Int$/USD); the strategy that includes ECLS resulted in sixty-two percent survival rate, and average cost of Int$ 23,000, with incremental cost-effectiveness ratio (ICER) of Int$ 62.215 per averted in-hospital death. Results were sensitive to device cost, and survival difference between strategies. In probabilistic sensitivity analysis, ECLS was consistently more costly and more effective than usual care; based on a willingness-to-pay of three times Brazilian gross domestic product (GDP) per capita (Int$ 45,000), there was twenty-seven percent probability of ECLS being cost-effective.Conclusions:ECLS has the potential to increase survival for cardiogenic shock, but would significantly increase costs. In the Brazilian public health system, the cost per averted in-hospital death is 4.1 times the domestic GDP per capita.

scholarly journals Feasibility, safety, and resource utilisation of active mobilisation of patients on extracorporeal life support: a prospective observational study

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Stephan Braune ◽  
Patrick Bojes ◽  
Anne Mecklenburg ◽  
Federico Angriman ◽  
Gerold Soeffker ◽  
...  
Keyword(s):  
Critically Ill ◽  
Critically Ill Patients ◽  
Life Support ◽  
Extracorporeal Life Support ◽  
Median Number ◽  
Activity Level ◽  
Resource Utilisation ◽  
Team Members ◽  
Cannulation Site ◽  
Va Ecmo

Abstract Background There is scarce evidence on the feasibility, safety and resource utilisation of active mobilisation in critically ill patients on extracorporeal life support (ECLS). Methods This prospective observational single-centre study included all consecutive critically ill patients on ECLS admitted to an academic centre in Germany over a time period of one year. The level of mobilisation was categorised according to the ICU Mobility Scale (IMS). Primary outcome was complications during mobilisation. Results During the study period, active mobilisation with an activity level on the IMS of ≥ 3 was performed at least on one occasion in 43 out of 115 patients (37.4%). A total of 332 mobilisations with IMS ≥ 3 were performed during 1242 ECLS days (26.7%). ECLS configurations applied were va-ECMO (n = 63), vv-ECMO (n = 26), vv-ECCO2R (n = 12), av-ECCO2R (n = 10), and RVAD (n = 4). Femoral cannulation had been in place in 108 patients (93.9%). The median duration of all mobilisation activities with IMS ≥ 3 was 130 min (IQR 44–215). All mobilisations were undertaken by a multi-professional ECLS team with a median number of 3 team members involved (IQR 3–4). Bleeding from cannulation site requiring transfusion and/or surgery occurred in 6.9% of actively mobilised patients and in 15.3% of non-mobilised patients. During one mobilisation episode, accidental femoral cannula displacement occurred with immediate and effective recannulation. Sedation was the major reason for non-mobilisation. Conclusions Active mobilisation (IMS ≥ 3) of ECLS patients undertaken by an experienced multi-professional team was feasible, and complications were infrequent and managed successfully. Larger prospective multicentre studies are needed to further evaluate early goal directed sedation and mobilisation bundles in patients on ECLS.

Role of extracorporeal life support in thoracic surgery

2020 ◽  
Vol 99 (10) ◽  
Keyword(s):  
Thoracic Surgery ◽  
Extracorporeal Circulation ◽  
Life Support ◽  
Close Contact ◽  
Extracorporeal Life Support ◽  
Tumour Resection ◽  
R0 Resection ◽  
Malignant Tumours ◽  
En Bloc ◽  
Frequent Use

Besides the conventional extracorporeal circulation, commonly used in cardiac surgery, the methods of extracorporeal life support (ECLS) have been applied ever more frequently in thoracic surgery in recent years. The most commonly used modalities of such supports include extracorporeal membrane oxygenation (ECMO) and the Novalung interventional lung assist device (iLA). Successful application of ECLS has led to its more frequent use in general thoracic surgery, especially as a tool to treat hypercapnia and to ensure oxygenation and haemodynamic support. However, these methods are essential in lung transplant programmes; without their help, in most cases, it would not be possible to perform the transplantatioz or prevent the severe complications associated with critical primary graft dysfunction. Additionally, the extracorporeal circulation also facilitates the performing of specific surgical procedures that would not be feasible under standard conditions or would be associated with an inadequate risk. The application of extracorporeal life supports can fundamentally increase the level of resection when treating advanced intrathoracic malignancies that are in close contact with the heart and large vessels or even directly extend into them. Without the possibility of resecting such structures en bloc, together with the tumour, and, thus, achieving an R0 resection, these malignant tumours are often directly contraindicated for surgery or are operated non-radically, i.e. unsuccessfully. Complete tumour resection is the most important prognostic factor in the surgery.

Diagnosis of coronary affection in patients with AADA and treatment of postcardiotomy myocardial failure using extracorporeal life support (ECLS)

2014 ◽  
Vol 17 (5) ◽  
pp. 253 ◽  
Author(s):  
Sabina P W Guenther ◽  
Sven Peterss ◽  
Angela Reichelt ◽  
Frank Born ◽  
Matthias Fischer ◽  
...  
Keyword(s):  
Heart Failure ◽  
Coronary Artery ◽  
Life Support ◽  
Extracorporeal Life Support ◽  
Artery Bypass ◽  
Preoperative Evaluation ◽  
Left Heart Failure ◽  
Myocardial Failure ◽  
Coronary Abnormalities ◽  
Ventricular Support

<p><b>Background:</b> Myocardial ischemia due to concomitant coronary artery disease (CAD) or coronary dissection in patients with acute aortic dissection type Stanford A (AADA) is associated with myocardial failure and poor outcomes. Preoperative coronary angiography in this group of patients is still debated. The use of CT scan to diagnose coronary affection along with the establishment of high-pitched dual-spiral CT protocols are essential for improving outcomes.</p><p><b>Methods:</b> We retrospectively analyzed six AADA patients with heart failure who were treated using extracorporeal life support (ECLS). Options for diagnosing coronary affection and different therapeutic strategies for postcardiotomy cardiogenic shock in this patient cohort are discussed.</p><p><b>Results:</b> Retrospective review of CT images showed coronary abnormalities in 83% (n = 5). Four patients (67%) underwent unplanned coronary artery bypass grafting (CABG). ECLS was instituted in 67% (n = 4) due to left heart failure and in 33% (n = 2) due to right heart failure. Thirty day mortality was 67% (n = 4). The two patients that received ECLS for right ventricular support survived and both had undergone CABG.</p><p><b>Conclusion:</b> Besides preoperative evaluation of the extent of the dissection, focus on coronary affection in CT-scans helps to triage the operative procedure. Hybrid operating rooms allow for immediate interventional and/or surgical treatment and enable for immediate control of revascularization results. The use of ECLS over other types of ventricular support systems may allow for myocardial recovery in selected cases.</p>

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