Abstract Background Critically ill patients are exposed to several physical and emotional stressors, needing analgesic and sedative drugs to tolerate invasive procedures and the harsh intensive care ...unit (ICU) environment. However, this pharmacological therapy presents several side effects: guidelines suggest using a light sedation target, keeping critically ill patients calm, conscious, and cooperative. Personalized music therapy (MT) can reduce stress and anxiety, decreasing the need for drugs. The aim of the current investigation is to compare different approaches for MT in the ICU: a personalized approach, with music selected by patients/families and listened through headphones, or a generalized approach, with ambient music chosen by a music therapist and transmitted through speakers. Primary outcome: number of days “free from neuroactive drugs” in the first 28 days after ICU admission. Secondary outcomes: total amount of neuroactive drugs (midazolam, propofol, morphine, fentanyl, haloperidol), stress during ICU stay (sleep at night, anxiety and agitation, use of physical restraints, stressors evaluated at discharge), the feasibility of generalized MT (interruptions requested by staff members and patients/families). Methods Randomized, controlled trial with three groups of critically ill adults: a control group, without MT; a personalized MT group, with music for at least 2 h per day; a generalized MT group, with music for 12.5 h/day, subdivided into fifteen 50-min periods. Discussion One hundred fifty-three patients are expected to be enrolled. This publication presents the rationale and the study methods, particularly the strategies used to build the generalized MT playlist. From a preliminary analysis, generalized MT seems feasible in the ICU and is positively received by staff members, critically ill patients, and families. Trial registration ClinicalTrials.gov Identifier: NCT03280329. September 12, 2017.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Coronavirus disease 2019 (COVID-19) infection may trigger a multi-systemic disease involving different organs. There has been growing interest regarding the harmful effects of COVID-19 on the ...cardiovascular system. This systematic review aims to systematically analyze papers reporting echocardiographic findings in hospitalized COVID-19 subjects.
We included prospective and retrospective studies reporting echocardiography data in >10 hospitalized adult subjects with COVID-19; from 1st February 2020 to 15th January 2021.
The primary electronic search identified 1120 articles. Twenty-nine studies were finally included, enrolling 3944 subjects. Overall the studies included a median of 68.0% (45.5–100.0) of patients admitted to ICU. Ten studies (34.4%) were retrospective, and 20 (68.9%) single-centred. Overall enrolling 1367 subjects, three studies reported normal echocardiographic findings in 49 ± 18% of cases. Seven studies (24.1%) analyzed the association between echocardiographic findings and mortality, mostly related to right ventricular (RV) dysfunction.
Data regarding the use of echocardiography on hospitalized, predominantly ICU, COVID-19 patients were retrieved from studies with heterogeneous designs, variable sample sizes, and severity scores. Normal echocardiographic findings were reported in about 50% of subjects, with LVEF usually not affected. Overall, RV dysfunction seems more likely associated with increased mortality.
CRD42020218439.
•The COVID-19 is frequently characterized by cardiac dysfunction, which is inconsistently defined in the literature.•Normal echocardiographic examination has been reported in about 50% of patients.•Left ventricle ejection fraction is usually not affected while diastolic function has been poorly assessed.•Overall, right ventricle dysfunction may be associated with increased mortality.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
In this study we evaluated the effect of fluid challenge (FC) administration in elective surgical patients with low or normal blood pressure. Secondarily, we appraised the pharmacodynamic effect of ...FC in normotensive and hypotensive patients. We assessed five merged datasets of patients with a baseline mean arterial pressure (MAP) above or below 65 mmHg and assessed the changes of systolic, diastolic, mean and dicrotic arterial pressures, dynamic indexes of fluid responsiveness and arterial elastance over a 10-min infusion. The hemodynamic effect was assessed by considering the net area under the curve (AUC), the maximal percentage difference from baseline (d
max
), the time when the maximal value was observed (t
max
) and change from baseline at 5-min (d
5
) after FC end. A stroke volume index increase > 10% with respect to the baseline value after FC administration indicated fluid response. Two hundred-seventeen patients were analysed 102 (47.0%) fluid responders. On average, FC restored a MAP
≥
65 mmHg after 5 min. The AUCs and the d
max
of pressure variables and arterial elastance of hypotensive patients were all significantly greater than normotensive patients. Pressure variables and arterial elastance changes in the hypotensive group were all significantly higher at d
5
as compared to the normotensive group. In hypotensive patients, FC restores a MAP
≥
65 mmHg after 5 min from infusion start. The hemodynamic profile of FC in hypotensive and normotensive patients is different; both the magnitude of pressure augmentation and duration is greater in the hypotensive group.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, VSZLJ, ZAGLJ
Hemodynamic optimization during sepsis and septic shock is based on a prompt and large fluid resuscitation strategy associated with early administration of norepinephrine. In our hospital, ...norepinephrine is administered in the emergency department (ED), within a protocol-guided management context, to reduce norepinephrine infusion timing due to central line insertion. This choice, however, can be associated with side effects.
We conducted a retrospective analysis regarding the safety of norepinephrine in the ED. We also appraised the association between in-hospital mortality and predefined ED variables and patients' admission severity scores.
This was a retrospective analysis of electronic sheets of the ED of a tertiary hospital in the North of Italy. Outcomes measure and analysis: Electronic documentation was assessed to identify local and systemic side effects. We considered two subgroups of patients according to the in-hospital clinical paths: (1) those admitted in the intensive care unit (ICU); and (2) those who received a ceiling of care decision. We collected and considered variables related to septic shock treatment in the ED and analyzed their association with in-hospital mortality.
We considered a two-year period, including 108,033 ED accesses, and ultimately analyzed data from 127 patients. Side effects related to the use of this drug were reported in five (3.9%) patients. Thirty patients (23.6%) were transferred to the ICU from the ED, of whom six (20.0%) died. Twenty-eight patients (22.0%) received a ceiling of care indication, of whom 21 (75.0%) died. Of the 69 (54.3%) finally discharged to either medical or surgical wards, 21 (30.4%) died. ICU admission was the only variable significantly associated to in-hospital mortality in the multivariable analysis OR (95% CI) = 4.48 (1.52-13.22);
-value = 0.007.
Norepinephrine peripheral infusion in the ED was associated with a low incidence of adverse events requiring discontinuation (3.9%). It could be considered safe within <12 h when a specific line management protocol and pump infusion protocol are adopted. None of the variables related to septic shock management affected in-hospital mortality, except for the patient's ICU admission.
During the coronavirus disease 2019 (COVID-19) outbreak, a critical care outreach team was implemented in our hospital to guarantee multidisciplinary patient assessment at admission and prompt ICU ...support in medical wards. In this paper, we report the activity plan results and describe the baseline characteristics of the referred subjects.
We retrospectively evaluated data from 125 subjects referred to the critical care outreach team from March 22 to April 22, 2020. We considered subjects with a ceiling of care decision, with those deemed eligible assigned to level 3 care (ward subgroup), and those deemed ineligible admitted to the ICU (ICU subgroup). Quality indicators of the outreach team plan delivery included number of cardiac arrest calls, number of intubations in level 2 areas, and ineffective palliative support.
We enrolled 125 consecutive adult subjects with a confirmed diagnosis of COVID-19. We did not report any emergency endotracheal intubations in the clinical ward. In the care ceiling subgroup, we had 2 (3.3%) emergency calls for cardiac arrest, whereas signs of ineffective palliative support were reported in 5 subjects (12.5%). Noninvasive forms of respiratory assistance were delivered to 40.0% of subjects in the ward subgroup (median 3 d interquartile range (IQR) 2-5), to 45.9% of subjects in the care ceiling subgroup (median 5 d IQR 3-7), and to 64.7% of subjects in the ICU subgroup (median 2.5 d IQR 1-3). Thirty of the 31 ward subjects (96.7%), 26 of the 34 ICU subjects, (76.4%), and 19 of the 61 ceiling of care subjects (31.1%) were discharged.
In the context of a hospital and ICU surge, a multidisciplinary daily plan supported by a dedicated critical care outreach team was associated with a low rate of cardiac arrest calls, no emergency intubations in the ward, and appropriate palliative care support for subjects with a ceiling of care decision.
A patient with coronary artery fistula should be considered as high risk for intraoperative hemodynamic decompensation. In this article, we report the case of a 70-year-old man affected by a complex ...congenital coronary artery fistula defect. The patient underwent general anesthesia for spine surgery with permissive hypotension. The development of sudden intraoperative tachyarrhythmia with hemodynamic instability required immediate resuscitation and interruption of surgery. The claim advanced is that in patients with a coronary artery fistula permissive hypotension might be considered an option only if strictly necessary and real-time cardiac monitoring including transesophageal echocardiography is available to immediately detect and treat acute cardiac impairment.
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NUK, OILJ, SAZU, UKNU, UL, UM, UPUK
Purpose
A number of studies performed in the operating room evaluated the hemodynamic effects of the fluid challenge (FC), solely considering the effect before and after the infusion. Few studies ...have investigated the pharmacodynamic effect of the FC on hemodynamic flow and pressure variables. We designed this trial aiming at describing the pharmacodynamic profile of two different FC infusion times, of a fixed dose of 4 ml kg
−1
.
Methods
Forty-nine elective neurosurgical patients received two consecutive FCs of 4 ml kg
−1
of crystalloids in 10 (FC
10
) or 20 (FC
20
) minutes, in a random order. Fluid responsiveness was defined as stroke volume index increase ≥ 10%. We assessed the net area under the curve (AUC), the maximal percentage difference from baseline (d
max
), time when the d
max
was observed (t
max
), change from baseline at 1-min (d
1
) and 5-min (d
5
) after FC end.
Results
After FC
10
and FC
20,
25 (51%) and 14 (29%) of 49 patients were classified as fluid responders (p = 0.001). With the exception of the AUCs of SAP and MAP, the AUCs of all the considered hemodynamic variables were comparable. The d
max
and the t
max
were overall comparable. In both groups, the hemodynamic effects on flow variables were dissipated within 5 min after FC end.
Conclusions
The infusion time of FC administration affects fluid responsiveness, being higher for FC
10
as compared to FC
20
. The effect on flow variables of either FCs fades 5 min after the end of infusion.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, VSZLJ, ZAGLJ
The SAVE-MORE trial demonstrated that anakinra treatment in COVID-19 pneumonia with plasma soluble urokinase plasminogen activator (suPAR) levels of 6 ng/mL or more was associated with 0.36 odds for ...a worse outcome compared to placebo when expressed by the WHO-Clinical Progression Scale (CPS) at day 28. Herein, we report the results of subgroup analyses and long-term outcomes.
This prospective, double-blind, randomised clinical trial, recruited patients with a confirmed SARS-CoV-2 infection, in need of hospitalisation, lower respiratory tract infection and plasma suPAR ≥6 ng/mL from 37 academic and community hospitals in Greece and Italy. Patients were 1:2 randomised to subcutaneous treatment with placebo or anakinra (100 mg) once daily for 10 days. Pre-defined subgroups of Charlson's comorbidity index (CCI), sex, age, level of suPAR, and time from symptom onset were analysed for the primary endpoint (overall comparison of distribution of frequencies of the scores from the WHO-CPS between treatments on day 28), by multivariable ordinal regression analysis in the intention to treat (ITT) population. This trial is registered with the EU Clinical Trials Register (2020-005828-11) and ClinicalTrials.gov (NCT04680949).
Patients were enrolled between 23 December 2020 and 31 March 2021; 189 patients in the placebo arm and 405 patients in the anakinra arm were the ITT population. Multivariable analysis showed that anakinra treatment was accompanied by significantly lower odds for worse outcome compared to placebo at day 28 for all studied subgroups (CCI ≥ 2, OR: 0.34, 95% confidence intervals CI 0.22–0.50; CCI < 2, OR: 0.38, 95% CI 0.21–0.68; suPAR > 9 ng/mL, OR: 0.35, 95% CI 0.19–0.66; suPAR 6–9 ng/mL, OR: 0.35, 95% CI 0.24–0.52; patients ≥65 years, OR: 0.41, 95% CI 0.25–0.66; and patients <65 years, OR: 0.29, 95% CI 0.19–0.45). The benefit was uniform, irrespective of the time from start of symptoms until the start of the study drug. At days 60 and 90, anakinra treatment had odds of 0.40 (95% CI 0.28–0.57) and 0.46 (95% CI 0.32–0.67) respectively, for a worse outcome compared to placebo. The costs of general ward stay, ICU stay, and drugs were lower with anakinra treatment.
Anakinra represents an important therapeutic tool in the management of COVID-19 that may be administered in all subgroups of patients; benefits are maintained until day 90.
Hellenic Institute for the Study of Sepsis; Swedish Orphan Biovitrum AB.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background: The SAVE-MORE trial demonstrated that anakinra treatment in COVID-19 pneumonia with plasma soluble urokinase plasminogen activator (suPAR) levels of 6 ng/mL or more was associated with ...0.36 odds for a worse outcome compared to placebo when expressed by the WHO-Clinical Progression Scale (CPS) at day 28. Herein, we report the results of subgroup analyses and long-term outcomes. Methods: This prospective, double-blind, randomised clinical trial, recruited patients with a confirmed SARS-CoV-2 infection, in need of hospitalisation, lower respiratory tract infection and plasma suPAR ≥6 ng/mL from 37 academic and community hospitals in Greece and Italy. Patients were 1:2 randomised to subcutaneous treatment with placebo or anakinra (100 mg) once daily for 10 days. Pre-defined subgroups of Charlson's comorbidity index (CCI), sex, age, level of suPAR, and time from symptom onset were analysed for the primary endpoint (overall comparison of distribution of frequencies of the scores from the WHO-CPS between treatments on day 28), by multivariable ordinal regression analysis in the intention to treat (ITT) population. This trial is registered with the EU Clinical Trials Register (2020-005828-11) and ClinicalTrials.gov (NCT04680949). Findings: Patients were enrolled between 23 December 2020 and 31 March 2021; 189 patients in the placebo arm and 405 patients in the anakinra arm were the ITT population. Multivariable analysis showed that anakinra treatment was accompanied by significantly lower odds for worse outcome compared to placebo at day 28 for all studied subgroups (CCI ≥ 2, OR: 0.34, 95% confidence intervals CI 0.22–0.50; CCI < 2, OR: 0.38, 95% CI 0.21–0.68; suPAR > 9 ng/mL, OR: 0.35, 95% CI 0.19–0.66; suPAR 6–9 ng/mL, OR: 0.35, 95% CI 0.24–0.52; patients ≥65 years, OR: 0.41, 95% CI 0.25–0.66; and patients <65 years, OR: 0.29, 95% CI 0.19–0.45). The benefit was uniform, irrespective of the time from start of symptoms until the start of the study drug. At days 60 and 90, anakinra treatment had odds of 0.40 (95% CI 0.28–0.57) and 0.46 (95% CI 0.32–0.67) respectively, for a worse outcome compared to placebo. The costs of general ward stay, ICU stay, and drugs were lower with anakinra treatment. Interpretation: Anakinra represents an important therapeutic tool in the management of COVID-19 that may be administered in all subgroups of patients; benefits are maintained until day 90. Funding: Hellenic Institute for the Study of Sepsis; Swedish Orphan Biovitrum AB.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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