Faculty Opinions recommendation of Adverse events with medical devices in anesthesia and intensive care unit patients recorded in the French safety database in 2005-2006.

Author(s):  
Stefan De Hert
2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Afonso Santos ◽  
Eunice Cacheira ◽  
Sílvia Coelho ◽  
Paulo Telles Freitas

Abstract Background and Aims Preeclampsia is potentially serious complication of pregnacy and frequently requires admission in ICU. Management of this condition involves treatment with magnesium sulfate to prevent progression to eclampsia or even more adverse outcomes such as maternal or fetal death. However the exact dose of magnesium needed is still to be determined and few studies have analyzed the impact of this therapheutic intervention in women admitted in intensive care units, in terms of outcomes and adverse effects. Herein, we present a series of patients diagnosed with preeclampsia, including its most severe presentations with eclampsia or HELLP syndrome, admitted in an intensive care unit. Method Demographic, clinical and laboratorial data of women admitted between January-2016 and December-2018 to the Polyvalent Intensive Care Unit (ICU) of Hospital Fernando Fonseca, a tertiary Hospital in Portugal, with the diagnosis of preeclampsia, were retrospectively collected. Diagnosis of preeclampsia, HELLP syndrome and eclampsia were performed according to the ISSHP criteria (2004). Acute Kidney Injury (AKI) was defined according to the KDIGO criteria. The study was approved by the Ethical Committee of the institution. Results 42 patients were included, 52.3% (n=22) diagnosed as non-severe preeclampsia; 31% (n=13) as HELLP syndrome and 16.7% (n=7) as eclampsia. Mean age at presentation was 29.6±6.6 years old, with 52,4% (n=22) caucasian and 47.6% (n=20) black. Most patients were admitted in ICU in post-partum period, after cesarian delivery in 95.2% (n=40). Seven patients (16.7%) had a previous diagnosis of hypertension; 11.9% (n=5) were obese; none has previous chronic kidney disease. At presentation, most patients diagnosed with preeclampsia had three diagnostic criteria (28.6%, n=12), including hypertension. Renal dysfunction was found in 80.9% (n=34) of patients, with proteinuria >200mg/dL in 69% (n=29) and AKI in 19% (n=8). Mean Hb of 11.1±2.1g/dL, with median platelet count of 126000/uL (IQR 72000-201500) and median LDH of 388mg/dL (IQR 240-773). Pre-partum magnesium sulfate treatment was initiated in 78.6% (n=33) of patients, but only 2.4% (n=1) had previous magnesemia levels determination. During the stay in ICU, daily levels of seric magnesium levels were obtained, with the highest median values found at day one after admission. Adverse events related to hypermagnesemia (bradipnea) occurred in 50% (n=21) of patients. In six patients (14.3%), treatment was stopped because of high levels of magnesemia or adverse events. 14.3% (n=6) progressed to eclampsia and fetal death occured also in 14.3% (n=6). Maternal deaths did not occur. By logistic binary regression we found out that weight was an independent risk factor for the development of the composite outcome of eclampsia or fetal death, when adjusted to age, race, AKI, hemoglobin, platelet count, ALT, LDH, serum albumin and proteinuria. (p=0.04). However, when Magnesium was included in the analysis, all variables lost significance. An association between SOFA and SAPS scores and the occurrence of the composite outcome has been found (p= 0.03 and p=0.019, respectively). Conclusion Most patients with preeclampsia received treatment with magnesium sulfate without previous measurement of serum levels. Bradipnea occurred in 50% of cases and treatment had to be stooped in almost 15%. Nevertheless, magnesium levels were not independently associated with the composite outcome of fetal death or eclampsia. Future studies should evaluate if a dose adjusted to a specific target of magnesium seric level could be associated with less adverse effects while still reducing the risk associated with preeclampsia.


2019 ◽  
Vol 59 (3) ◽  
pp. 163-168
Author(s):  
Mark P. Fitzgerald ◽  
Maureen Donnelly ◽  
Lisa Vala ◽  
Linda Allen-Napoli ◽  
Nicholas S. Abend

2019 ◽  
Vol 179 (3) ◽  
pp. 473-482
Author(s):  
Pablo G. Eulmesekian ◽  
Juan P. Alvarez ◽  
José M. Ceriani Cernadas ◽  
Augusto Pérez ◽  
Stefanía Berberis ◽  
...  

IEEE Access ◽  
2020 ◽  
Vol 8 ◽  
pp. 64193-64224
Author(s):  
Carmel Eliash ◽  
Isaac Lazar ◽  
Nir Nissim

2019 ◽  
Vol 12 ◽  
pp. 175628481985825 ◽  
Author(s):  
Rosalie C. Oey ◽  
Lennart E.M. Buck ◽  
Nicole S. Erler ◽  
Henk R. van Buuren ◽  
Robert A. de Man

Background: After 5  years since the registration of rifaximin-α as a secondary prophylaxis for overt hepatic encephalopathy (HE) in the Netherlands, we aimed to evaluate the use of hospital resources and safety of rifaximin-α treatment in a real-world setting. Methods: We carried out prospective identification of all patients using rifaximin-α for overt HE. We assessed hospital resource use, bacterial infections, and adverse events during 6-month episodes before and after rifaximin-α initiation. Results: During 26 months we included 127 patients [71.7% male; median age 60.8 years (interquartile range: 56.2–66.1); median model for end-stage liver disease (MELD) score 15.0 (interquartile range: 12.1–20.4); 98% using lactulose treatment]. When comparing the first 6 months after rifaximin-α initiation with the prior 6 months, HE-related hospital admissions decreased (0.86 to 0.41 admissions/patient; p < 0.001), as well as the mean length of stay (8.85 to 3.79 bed days/admission; p < 0.001). No significant differences were found regarding HE-related intensive care unit admissions (0.09 to 0.06 admission/patient; p = 0.253), stay on the intensive care unit (0.43 to 0.57 bed days/admission; p = 0.661), emergency department visits (0.66 to 0.51 visits/patient; p = 0.220), outpatient clinic visits (2.49 to 3.30 bed visits/patient; p = 0.240), or bacterial infections (0.41 to 0.35 infections/patient; p = 0.523). Adverse events were recorded in 2.4% of patients. Conclusions: The addition of rifaximin-α to lactulose treatment was associated with a significant reduction in the number and length of HE-related hospitalizations for overt HE. Rifaximin-α treatment was well tolerated.


2011 ◽  
Vol 115 (5) ◽  
pp. 1033-1043 ◽  
Author(s):  
Ryan Crowley ◽  
Elizabeth Sanchez ◽  
Jonathan K. Ho ◽  
Kate J. Lee ◽  
Johanna Schwarzenberger ◽  
...  

Background The role of continuous central venous oxygen saturation (ScvO₂) oximetry during pediatric cardiac surgery for predicting adverse outcomes is not known. Using a recently available continuous ScvO₂ oximetry catheter, we examined the association between venous oxygen desaturations and patient outcomes. We hypothesized that central venous oxygen desaturations are associated with adverse clinical outcomes. Methods Fifty-four pediatric patients undergoing cardiac surgery were prospectively enrolled in an unblinded observational study. ScvO₂ was measured continuously in the operating room and for up to 24 h post-Intensive Care Unit admission. The relationships between ScvO₂ desaturations, clinical outcomes, and major adverse events were determined. Results More than 18 min of venous saturations less than 40% were associated with major adverse events with 100% sensitivity and 97.6% specificity. Significant correlations resulted between the ScvO₂ area under the curve less than 40% and creatinine clearance at 12 h in the Intensive Care Unit (r = -0.58), Intensive Care Unit length of stay (r = 0.56), max inotrope use (r = 0.52), inotrope use at 24 h (r = 0.40), inotrope index score (r = 0.39), hospital length of stay (r = 0.36), and length of intubation (r = 0.32). Conclusions We demonstrate that ScvO₂ desaturations by continuous oximetry are associated with major adverse events in pediatric patients undergoing cardiac surgery. The most significant associations with major adverse events are seen in patients with greater than 18 min of central venous saturations less than 40%. Our results support the further investigation of ScvO₂ as a potential target parameter in high-risk pediatric patients to minimize the risk of major adverse events.


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