Prospective randomized double-blind study to evaluate the superiority of Vasopressin versus Norepinephrine in the management of the patient at renal risk undergoing cardiac surgery with cardiopulmonary bypass (NOVACC trial).

BACKGROUND: Cardiac surgery-associated acute kidney injury (CS-AKI) affects up to 30% of patients, increasing morbidity and healthcare costs. This condition results from complex factors like ischemia-reperfusion injury and renal hemodynamic changes, often exacerbated by surgical procedures. Norepinephrine, commonly used in cardiac surgeries, may heighten the risk of CS-AKI. In contrast, vasopressin, a noncatecholaminergic agent, shows potential in preserving renal function by favorably affecting renal hemodynamic. Preliminary findings, suggest vasopressin could reduce the incidence of CS-AKI compared to norepinephrine. Additionally, vasopressin is linked to a lower incidence of postoperative atrial fibrillation, another factor contributing to longer hospital stays and higher costs. This study hypothesizes that vasopressin could effectively reduce CS-AKI occurrence and severity by optimizing renal perfusion during cardiac surgeries. STUDY DESIGN: The NOVACC trial (NCT05568160) is a multicenter, randomized, double blinded superiority-controlled trial testing the superiority of vasopressin over norepinephrine in patients scheduled for cardiac surgery with cardiopulmonary bypass (CPB). The primary composite end point is the occurrence of acute kidney injury and death. The secondary end points are neurological, cardiologic, digestive, and vasopressor related complications at day 7, day 30, day 90, hospital and intensive care unit lengths of stay, medico-economic costs at day 90. CONCLUSION: The NOVACC trial will assess the effectiveness of vasopressin in cardiac surgery with CPB in reducing acute kidney injury, mortality, and medical costs. CLINICAL TRIAL REGISTRATION: NCT05568160.

Maintenance of beta-blockers and cardiac surgery-related outcomes: a prospective propensity-matched multicentre analysis.

BACKGROUND: We investigated the effects of maintaining beta-blockers on the day of surgery on the incidence of atrial fibrillation and postoperative acute kidney injury (AKI) in patients undergoing cardiac surgery. METHODS: We conducted a multicentre prospective observational study with propensity matching on patients treated with beta-blockers. We collected their baseline patient characteristics, comorbidities, and operative and postoperative outcomes. The endpoints were postoperative atrial fibrillation and AKI after cardiac surgery. RESULTS: Of the 1789 included patients, propensity matching led to 583 patients in each group. Maintenance of beta-blockers was not associated with a reduced risk of atrial fibrillation (odds ratio: 0.86 [95% confidence interval 0.66-1.14], P=0.335; 141 patients [24.2%] vs 126 patients [21.6%]). Sensitivity analysis did not demonstrate association between beta-blocker maintenance and atrial fibrillation after cardiac surgery (odds ratio: 0.93 [95% confidence interval: 0.72-1.22], P=0.625). Maintenance of beta-blockers was associated with a higher rate of norepinephrine use (415 [71.2%] vs 465 [79.8%], P=0.0001) and postoperative AKI (124 [21.3%] vs 159 [27.3%], P=0.0127). No statistically significant difference was observed in ICU length of stay. CONCLUSIONS: Maintenance of beta-blockers on the day of surgery was not associated with a reduced incidence of postoperative atrial fibrillation. However, maintenance of beta-blockers was associated with increased usage of vasopressors, potentially contributing to adverse postoperative renal events. CLINICAL TRIAL REGISTRATION: NCT04769752.

Impact of early postoperative blood glucose variability on serum endocan level in cardiac surgery patients: a sub study of the ENDOLUNG observational study.

BACKGROUND: Early postoperative glycemic variability is associated with worse outcome after cardiac surgery, but the underlying mechanisms remain unknown. This study aimed to describe the relationship between postoperative glycemic variability and endothelial function, as assessed by serum endocan level in cardiac surgery patients. METHODS: We performed a post hoc analysis of patients included in the single-center observational ENDOLUNG study. Adult patients who underwent planned isolated coronary artery bypass graft surgery were eligible. Postoperative glycemic variability was assessed by calculating the coefficient of variability (CV) of blood glucose measured within 24 (CV24) and 48 (CV48) hours after surgery. Serum endocan level was measured at 24 (Endocan24) and 48 (Endocan48) hours after surgery. Pearson's correlation coefficient with 95% confidence interval (95% CI) was calculated between CV24 and Endocan24, and between CV48 and Endocan48. RESULTS: Data from 177 patients were analyzed. Median CV24 and CV48 were 18% (range 7 to 39%) and 20% (range 7 to 35%) respectively. Neither CV48 nor CV24 were significantly correlated to Endocan48 and Endocan24 respectively (r (95% CI) = 0.150 (0.001 to 0.290; and r (95% CI) = 0.080 (-0.070 to 0.220), respectively). CONCLUSIONS: Early postoperative glycemic variability within 48 h after planned cardiac surgery does not appear to be correlated with postoperative serum endocan level. CLINICAL TRIAL REGISTRATION NUMBER: NCT02542423.

Optimizing PO2 during peripheral veno-arterial ECMO: a narrative review.

During refractory cardiogenic shock and cardiac arrest, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is used to restore a circulatory output. However, it also impacts significantly arterial oxygenation. Recent guidelines of the Extracorporeal Life Support Organization (ELSO) recommend targeting postoxygenator partial pressure of oxygen (PPOSTO2) around 150 mmHg. In this narrative review, we intend to summarize the rationale and evidence for this PPOSTO2 target recommendation. Because this is the most used configuration, we focus on peripheral VA-ECMO. To date, clinicians do not know how to set the sweep gas oxygen fraction (FSO2). Because of the oxygenator's performance, arterial hyperoxemia is common during VA-ECMO support. Interpretation of oxygenation is complex in this setting because of the dual circulation phenomenon, depending on both the native cardiac output and the VA-ECMO blood flow. Such dual circulation results in dual oxygenation, with heterogeneous oxygen partial pressure (PO2) along the aorta, and heterogeneous oxygenation between organs, depending on the mixing zone location. Data regarding oxygenation during VA-ECMO are scarce, but several observational studies have reported an association between hyperoxemia and mortality, especially after refractory cardiac arrest. While hyperoxemia should be avoided, there are also more and more studies in non-ECMO patients suggesting the harm of a too restrictive oxygenation strategy. Finally, setting FSO2 to target strict normoxemia is challenging because continuous monitoring of postoxygenator oxygen saturation is not widely available. The threshold of PPOSTO2 around 150 mmHg is supported by limited evidence but aims at respecting a safe margin, avoiding both hypoxemia and severe hyperoxemia.

Continuous Transversus Abdominis Plane Infusion via Surgically Inserted Catheter for Postoperative Analgesia After Abdominal Aortic Surgery by Retroperitoneal Approach: TAPCACAO Study.

BACKGROUND: The purpose of our study was to evaluate the analgesic properties of continuous transversus abdominis plane (TAP) infusion with ropivacaine compared to placebo for postoperative analgesia in elective surgery of the abdominal aorta by retroperitoneal exposure. METHODS: We conducted a prospective, single-center, randomized, double-blind study comparing a group of patients with a TAP catheter undoing ropivacaine infusion with a placebo group. Patients received a left retroperitoneal pararectal exposure for abdominal aortic surgery. A continuous infusion catheter was placed under visual control by the surgeon before closure and removed after 48 hr. All patients had postoperative patient-controlled analgesia with morphine. The primary endpoint was morphine consumption during the first 24 hr. RESULTS: The analysis included 25 patients in the placebo group and 24 in the ropivacaine group. The average morphine consumption during the first 24 hr was significantly different, with 31 ± 16 mg in the ropivacaine group and 41 ± 17 mg in the placebo group (P = 0.019). At 48 hr, morphine consumption was still lower in the ropivacaine group (42 ± 26 mg) than in the placebo group (64 ± 25 mg) (P = 0.003). The opioid narcotic-related side effects of opioid infusion (postoperative nausea and vomiting, constipation) and length of hospital stay were similar in both populations. CONCLUSIONS: Our study showed that continuous TAP block with ropivacaine via surgically inserted catheter significantly decreased morphine consumption at 24 and 48 hr after elective abdominal aortic surgery by retroperitoneal exposure.

Semi-elemental versus polymeric formula for enteral nutrition in brain-injured critically ill patients: a randomized trial.

BACKGROUND: The properties of semi-elemental enteral nutrition might theoretically improve gastrointestinal tolerance in brain-injured patients, known to suffer gastroparesis. The purpose of this study was to compare the efficacy and tolerance of a semi-elemental versus a polymeric formula for enteral nutrition (EN) in brain-injured critically ill patients. METHODS: Prospective, randomized study including brain-injured adult patients [Glasgow Coma Scale (GCS) ≤ 8] with an expected duration of mechanical ventilation > 48 h. INTERVENTION: an enteral semi-elemental (SE group) or polymeric (P group) formula. EN was started within 36 h after admission to the intensive care unit and was delivered according to a standardized nurse-driven protocol. The primary endpoint was the percentage of patients who received both 60% of the daily energy goal at 3 days and 100% of the daily energy goal at 5 days after inclusion. Tolerance of EN was assessed by the rate of gastroparesis, vomiting and diarrhea. RESULTS: Respectively, 100 and 95 patients were analyzed in the SE and P groups: Age (57[44-65] versus 55[40-65] years) and GCS (6[3-7] versus 5[3-7]) did not differ between groups. The percentage of patients achieving the primary endpoint was similar (46% and 48%, respectively; relative risk (RR) [95% confidence interval (CI)] = 1.05 (0.78-1.42); p = 0.73). The mean daily energy intake was, respectively, 20.2 ± 6.3 versus 21.0 ± 6.5 kcal/kg/day (p = 0.42). Protein intakes were 1.3 ± 0.4 versus 1.1 ± 0.3 g/kg/day (p < 0.0001). Respectively, 18% versus 12% patients presented gastroparesis (p = 0.21), and 16% versus 8% patients suffered from diarrhea (p = 0.11). No patient presented vomiting in either group. CONCLUSION: Semi-elemental compared to polymeric formula did not improve daily energy intake or gastrointestinal tolerance of enteral nutrition. TRIAL REGISTRATION: EudraCT/ID-RCB 2012-A00078-35 (registered January 17, 2012).

Postoperative Neurocognitive Disorders After Closed-Loop Versus Manual Target Controlled-Infusion of Propofol and Remifentanil in Patients Undergoing Elective Major Noncardiac Surgery: The Randomized Controlled Postoperative Cognitive Dysfunction-Electroencephalographic-Guided Anesthetic Administration Trial.

BACKGROUND: The aim of the study was to investigate whether closed-loop compared to manual bispectral index (BIS)-guided target-controlled infusion of propofol and remifentanil could decrease the incidence of postoperative neurocognitive disorders after elective major noncardiac surgery. METHODS: Patients aged >50 admitted for elective major noncardiac surgery were included in a single-blind randomized (ratio 2:1) trial. The anesthetic protocol was allocated by randomization into either closed-loop or manual BIS-guided propofol and remifentanil titration. The BIS target range was 40-60. All patients had cognitive assessment the day before surgery and within 72 hours after surgery using a battery of neuropsychological tests. The primary outcome was the rate of postoperative neurocognitive disorders. Postoperative neurocognitive disorders were defined as a decrease >20% from baseline on at least 3 scores. Intergroup comparison of the primary outcome was performed using the χ2 test. RESULTS: A total of 143 and 61 patients were included in the closed-loop and manual groups, respectively (age: 66 [8] vs 66 [9] years). The primary outcome was observed in 18 (13%) and 10 (16%) patients of the closed-loop and manual groups, respectively (relative risk [95% confidence interval {CI}], 0.77 [0.38-1.57], P = .47). Intraoperative propofol consumption was lower (4.7 [1.4] vs 5.7 [1.4] mg·kg-1·h-1, mean difference [MD] [95% CI], -0.73 [-0.98 to -0.48], P < .0001) and the proportion of time within the BIS target range higher (84 [77-89] vs 74 [54-81]%, MD [95% CI], 0.94 [0.67-1.21], P < .0001) in the closed-loop group. CONCLUSIONS: Closed-loop compared to manual BIS-guided total intravenous anesthesia provided a significant reduction in episodes of an excessive depth of anesthesia while decreasing intraoperative propofol requirement but no evidence for a reduction of the incidence of postoperative neurocognitive disorders after elective major noncardiac surgery was observed.

Elevated D-dimers and lack of anticoagulation predict PE in severe COVID-19 patients.

BACKGROUND: Coronavirus disease 2019 (COVID-19) may predispose to venous thromboembolism. We determined factors independently associated with computed tomography pulmonary angiography (CTPA)-confirmed pulmonary embolism (PE) in hospitalised severe COVID-19 patients. METHODS: Among all (n=349) patients hospitalised for COVID-19 in a university hospital in a French region with a high rate of COVID-19, we analysed patients who underwent CTPA for clinical signs of severe disease (oxygen saturation measured by pulse oximetry ≤93% or breathing rate ≥30 breaths·min-1) or rapid clinical worsening. Multivariable analysis was performed using Firth penalised maximum likelihood estimates. RESULTS: 162 (46.4%) patients underwent CTPA (mean±sd age 65.6±13.0 years; 67.3% male (95% CI 59.5-75.5%). PE was diagnosed in 44 (27.2%) patients. Most PEs were segmental and the rate of PE-related right ventricular dysfunction was 15.9%. By multivariable analysis, the only two significant predictors of CTPA-confirmed PE were D-dimer level and the lack of any anticoagulant therapy (OR 4.0 (95% CI 2.4-6.7) per additional quartile and OR 4.5 (95% CI 1.1-7.4), respectively). Receiver operating characteristic curve analysis identified a D-dimer cut-off value of 2590 ng·mL-1 to best predict occurrence of PE (area under the curve 0.88, p<0.001, sensitivity 83.3%, specificity 83.8%). D-dimer level >2590 ng·mL-1 was associated with a 17-fold increase in the adjusted risk of PE. CONCLUSION: Elevated D-dimers (>2590 ng·mL-1) and absence of anticoagulant therapy predict PE in hospitalised COVID-19 patients with clinical signs of severity. These data strengthen the evidence base in favour of systematic anticoagulation, and suggest wider use of D-dimer guided CTPA to screen for PE in acutely ill hospitalised patients with COVID-19.

Epidemiology and outcome of patients admitted to intensive care after anaphylaxis in France: a retrospective multicentre study.

BACKGROUND: Few data are available on patients who have experienced anaphylaxis and were admitted to ICUs. The purpose of this observational study was to describe the epidemiology and management of these patients. METHODS: This was a multicentre retrospective study carried out in 23 French ICUs between 2012 and 2017. All patients who suffered anaphylaxis and were transferred to an ICU were included. Data were collected using an electronic database after approval by an ethics committee. RESULTS: A total of 339 patients were included, and 17 (5%) died secondary to anaphylaxis. The main triggers were drugs (77%), contrast media (11%), and food (7%). Epinephrine was administered before ICU admission in 88% of patients with Grade III anaphylaxis and 100% of patients with Grade IV anaphylaxis. Most patients with Grades III and IV anaphylaxes did not receive the recommended dose of i.v. fluid of 30 ml kg-1 within the first 4 h of ICU admission. The time to epinephrine administration was not statistically different between survivors and non-survivors, but non-survivors received a higher dose of epinephrine (median: 5 [3-10] vs 3 [2-7] mg; P<0.0001), which suggests that some forms of anaphylactic shock may be resistant to epinephrine. In multivariate analysis, only lactate concentration at ICU admission was a predictor of death (odds ratio: 1.47 [1.15-1.88]; P=0.002). CONCLUSIONS: Lactate concentration at ICU admission appeared to be the most reliable criterion for assessing prognosis. Epinephrine is widely used during anaphylaxis, but the volume of fluid resuscitation was consistently lower than recommended. CLINICAL TRIAL REGISTRATION: NCT04290507.

Impact of post-procedural glycemic variability on cardiovascular morbidity and mortality after transcatheter aortic valve implantation: a post hoc cohort analysis.

BACKGROUND: Glycemic variability is associated with worse outcomes after cardiac surgery, but the prognosis value of early glycemic variability after transcatheter aortic valve implantation is not known. This study was therefore designed to analyze the prognosis significance of post-procedural glycemic variability within 30 days after transcatheter aortic valve implantation. METHODS: A post hoc analysis of patients from our center included in the FRANCE and FRANCE-2 registries was conducted. Post-procedural glycemic variability was assessed by calculating the mean daily δ blood glucose during the first 2 days after transcatheter aortic valve implantation. Major complications within 30 days were death, stroke, myocardial infarction, acute heart failure, and life-threatening cardiac arrhythmias. RESULTS: We analyzed 160 patients (age (median [interquartile] = 84 [80-88] years; diabetes mellitus (n) = 41 (26%) patients; logistic Euroscore = 20 [12-32]). The median value of mean daily δ blood glucose was 4.3 mmol l-1. The rate of major complications within 30 days after procedure among patients with the lowest quartile of glycemic variability was 12%, increasing from 12 to 26%, and 39% in the second, third, and fourth quartiles, respectively. In multivariate analysis, glycemic variability was independently associated with an increased risk of major complications within 30 days after the procedure (odds ratio [95% CI] = 1.83 [1.19-2.83]; p = 0.006). CONCLUSIONS: This study showed that post-procedural glycemic variability was associated with an increased risk of major complications within 30 days after transcatheter aortic valve implantation. Trial registration Clinical trial registration number https://www.clinicaltrials.gov/ ; identifier: NCT02726958; date: April 4th, 2016.

Quality of life 10 years after cardiac surgery in adults: a long-term follow-up study.

BACKGROUND: Quality of life (QoL) is a multifactorial concept that assesses physical and mental health. We prospectively studied the quality of life of patients undergoing coronary artery bypass graft (CABG) surgery using the Short-Form 36-item questionnaire (SF-36) up to 10 years after surgery. METHODS: Between January 2000 and December 2002, all patients undergoing elective isolated CABG in the cardiac & thoracic surgery department of a large university hospital in Eastern France underwent initial QoL evaluation with the SF-36. The same questionnaire was mailed to every patient annually (± 2 weeks around the date of surgery) up to 10 years after their operation. We recorded socio-demographic and clinical variables at inclusion. Predictors of impaired QoL at 10 years were identified by logistic regression. RESULTS: A total of 272 patients (213 men, 59 women) were enrolled; mean age at inclusion was 65 ± 10 years. At 10 years post-surgery, 81 patients had died (29.7%). The physical component summary (PCS) score was significantly higher at 5 years after surgery than at baseline (p < 0.01), and significantly lower at 10 years than at 5 years (p < 0.01), although there remained a significant difference between 10-year PCS and baseline score (p = 0.004). The mental component summary (MCS) score was significantly higher at 5 years than at the time of surgery (p < 0.001), and remained significantly higher compared to baseline at 10 years after surgery (p = 0.010). By multivariate analysis, diabetes and dypsnea were both associated with worse PCS at 10 years, while lower age was associated with better 10-year PCS. Only diabetes was associated with impaired MCS at 10 years. CONCLUSIONS: Cardiac surgery appears to durably and positively affect both physical and mental components of quality of life.

Prevalence and Impact of Malnutrition in Patients Surgically Treated for Chronic Mesenteric Ischemia.

BACKGROUND: Patients suffering from chronic mesenteric ischemia are at risk of malnutrition due to the fear of food and weight loss. However, the impact of malnutrition on the morbidity and mortality at the time of surgery is not studied extensively, just as its prevalence. The main objective of this study was to evaluate the influence of malnutrition on the survival of the patients operated for chronic mesenteric ischemia. The secondary objectives were to evaluate the prevalence of malnutrition in this population and to evaluate the early complications after surgery according to the nutritional condition of the patients. METHODS: We conducted a monocentric retrospective observational study including consecutively all the patients operated for chronic mesenteric ischemia between 2005 and 2016. The nutritional status was determined a posteriori according to the criteria of the French High Health Authority using body mass index, the percentage of weight loss, and albumin. We thus divided the patients into 2 groups, "malnourished" and "non-malnourished." We compared the survival of the patients of the 2 groups with a log-rank test. RESULTS: We enrolled 54 patients including 35 men (65%), with a mean age of 68.1 years (±12.3). The prevalence of malnutrition was 70% (38 patients), including 9 severely malnourished patients (23.6%). Twenty-nine patients (53.7%) were treated by endovascular technique, and twenty-five had conventional surgery (46.3%). The type of management was not different between the 2 groups: 20 patients of the malnourished group (52.6%) and 9 patients of the non-malnourished group (56.3%) were treated by endovascular technique (P = 0.8). The 30-day mortality was null in the non-malnourished group, whereas ten patients (26.3%) died in the malnourished group (P = 0.02). The short-term complications were not significantly different between the malnourished and the non-malnourished groups (37% vs. 19%, P = 0.32). The mean duration of follow-up was 639 days (±660). The 3-year survival was not different between the endovascular group and the open surgery group (43% vs. 52%, P = 0.7). The 3-year survival was statistically higher in the non-malnourished group (87%) than in the malnourished group (49.6%) (P = 0.01). CONCLUSIONS: In our experience, preoperative malnutrition is a factor significantly decreasing the survival of the patients treated with open surgery or with endovascular technique for chronic mesenteric ischemia. A more optimal preoperative management of this malnutrition could improve the results of these procedures.

Evolution of Practices in Treatment of Abdominal Aortic Aneurysm in France between 2006 and 2015.

BACKGROUND: The main objective of this study was to identify the changes that have occurred in the treatment of abdominal aortic aneurysms (AAA) in France over a period of 10 years. MATERIALS AND METHODS: Comprehensive data for AAA surgical activity from all French health establishments between 2006 and 2015 were collected from the records of the "Agence Technique de l'Information sur l'Hospitalisation." Based on the common classification of medical procedures, our research was conducted on surgical procedures involving open and endovascular surgical treatment of AAA. A year-by-year descriptive analysis was completed for the number of procedures, the change in the type of surgery performed in each type of institution, and the mean duration of hospital stays. RESULTS: During the study period, the number of AAA treated increased overall by 28.2% (from 6,412 procedures in 2006 to 8,221 in 2015). The proportion of endovascular procedures increased in this period (from 27.0% in 2006 to 68.5% in 2015) like their number from 1,735 to 5,632. The number of fenestrated endovascular aneurysm repair (listed since 2013) increased from 251 to 373 in 3 years. Open repair decreased from 4,677 interventions in 2006 to 2,589 in 2015 with higher proportion of suprarenal clamping in open surgery (from 23% in 2006 to 40% in 2015). The number of ruptured AAA treated in open surgery remained stable over this period (473 in 2006 and 462 in 2015). CONCLUSIONS: In France, the number of AAA operated between 2006 and 2015 increased by 28.2%. There was a significant increase in endovascular techniques, which became largely predominant in 2015. In open repair, the proportion of complex procedures increased in this period. However, this transformation, which is in line with current recommendations and major publications, needs to be reassessed in the long term.

Impact of intravenous exenatide infusion for perioperative blood glucose control on myocardial ischemia-reperfusion injuries after coronary artery bypass graft surgery: sub study of the phase II/III ExSTRESS randomized trial.

BACKGROUND: The aim of the study was to investigate whether intravenous (iv) infusion of exenatide, a synthetic GLP-1 receptor agonist, could provide a protective effect against myocardial ischemia-reperfusion injury after coronary artery bypass graft (CABG) surgery. METHODS: A sub study analysis of patients > 18 years admitted for elective CABG and included in the ExSTRESS trial was conducted. Patients were randomized to receive either iv exenatide (1-h bolus of 0.05 µg min-1 followed by a constant infusion of 0.025 µg min-1) (exenatide group) or iv insulin therapy (control group) for blood glucose control (target range 100-139 mg dl-1) during the first 48 h after surgical incision. All serum levels of troponin I measured during routine care in the Cardiac Surgery ICU were recorded. The primary outcome was the highest value of plasma concentration of troponin I measured between 12 and 24 h after ICU admission. The proportion of patients presenting an echocardiographic left ventricular ejection fraction (LVEF) > 50% at the follow-up consultation was compared between the two groups. RESULTS: Finally, 43 and 49 patients were analyzed in the control and exenatide groups, respectively {age: 69 [61-76] versus 71 [63-75] years; baseline LVEF < 50%: 6 (14%) versus 16 (32%) patients; on-pump surgery: 29 (67%) versus 33 (67%) patients}. The primary outcome did not significantly differ between the two groups (3.34 [1.06-6.19] µg l-1 versus 2.64 [1.29-3.85] µg l-1 in the control and exenatide groups, respectively; mean difference (MD) [95% confidence interval (95% CI)] 0.16 [- 0.25; 0.57], p = 0.54). The highest troponin value measured during the first 72 h in the ICU was 6.34 [1.36-10.90] versus 5.04 [2.39-7.18] µg l-1, in the control and exenatide groups respectively (MD [95% CI] 0.20 [- 0.22; 0.61], p = 0.39). At the follow-up consultation, 5 (12%) versus 8 (16%) patients presented a LVEF < 50% in the control and in the exenatide groups respectively (relative risk [95% CI] 0.68 [0.16; 2.59], p = 0.56). CONCLUSIONS: Postoperative iv exenatide did not provide any additional cardioprotective effect compared to iv insulin in low-risk patients undergoing scheduled CABG surgery. Trial registration ClinicalTrials.gov Identifier NCT01969149, date of registration: January 7th, 2015; EudraCT No. 2009-009254-25 A, date of registration: January 6th, 2009.

Kinetics of endocan in patients undergoing cardiac surgery with and without cardiopulmonary bypass.

BACKGROUND: Endocan plays an important role in the processes of inflammation and infection. The use of cardiopulmonary bypass (CPB) during cardiac surgery can induce an inflammatory response. We aimed to describe the kinetics of endocan in patients undergoing cardiac surgery with and without the use of CPB. METHODS: Single-centre, observational study with retrospective analysis of prospectively collected data, to compare the kinetics of endocan in patients undergoing isolated coronary artery bypass graft (CABG) surgery. Endocan was measured at induction of general anesthesia (baseline), and at 6, 24, 48 and 72 h after the end of surgery. Patients were classified into two groups, namely those undergoing CPB (CPB group) and those without CPB (off-pump group). RESULTS: In total, 91 patients were included in this analysis: 61 patients in the CPB group and 30 in the off-pump group. There were no major significant differences between groups. Patients with CPB had a significantly higher level of endocan at 6 h (9.7 ±â€¯6.7 ng/ml vs 6.9 ±â€¯3.3 ng/ml, p = 0.03), but the difference was no longer statistically significant at subsequent timepoints. Endocan values were not significantly correlated with the duration of CPB (p = 0.53). CONCLUSION: Endocan levels in patients undergoing isolated CABG surgery with CPB are significantly higher at 6 h than in patients with off-pump surgery, and peaks earlier in those with CPB (6 h) than in those undergoing off-pump surgery (24 h).

Long-term compliance with a validated intravenous insulin therapy protocol in cardiac surgery patients: a quality improvement project.

QUALITY PROBLEM: Safe and efficient blood glucose (BG) level control after cardiac surgery relies on an intensive care unit (ICU) team-based approach, including implementation of a dynamic insulin therapy protocol (ITP). Long-term compliance with such a complex protocol is poorly addressed in the literature. The aim of this study was to assess the long-term compliance of nurses with the ITP, 7 years after its implementation in the ICU. INITIAL ASSESSMENT: A professional practice evaluation, integrated in a process of quality improvement program, was retrospectively conducted on 224 consecutive cardiac surgery patients over a 6-month period (PHASE 1). The timing of BG measurements and the insulin infusion rate adjustments (primary endpoints) were correctly performed according to protocol requirements in 35 and 53% of the cases, respectively. CHOICE OF SOLUTION AND IMPLEMENTATION: After systemic analysis of the causes of protocol deviations, four corrective measures aiming at improving both physician and nurse adherence to the protocol were implemented in the ICU. EVALUATION: Evaluation of 104 patients in PHASE 2 showed a significant improvement in both the timing of BG measurements (83 %, P < 0.001 vs. PHASE 1), and insulin infusion rate adjustments (76%, P < 0.001). LESSONS LEARNED: Seven years after the implementation of a dynamic insulin infusion protocol, major protocol deviations were observed. Identification of several causes after a professional practice evaluation and the implementation of simple corrective measures restored a high level of nurse compliance.

Clinical Effectiveness of Intravenous Exenatide Infusion in Perioperative Glycemic Control after Coronary Artery Bypass Graft Surgery: A Phase II/III Randomized Trial.

BACKGROUND: We aimed to assess the clinical effectiveness of intravenous exenatide compared to insulin in perioperative blood glucose control in coronary artery bypass grafting surgery patients. METHODS: Patients more than 18 yr old admitted for elective coronary artery bypass grafting were included in a phase II/III nonblinded randomized superiority trial. Current insulin use and creatinine clearance of less than 60 ml/min were exclusion criteria. Two groups were compared: the exenatide group, receiving exenatide (1-h bolus of 0.05 µg/min followed by a constant infusion of 0.025 µg/min), and the control group, receiving insulin therapy. The blood glucose target range was 100 to 139 mg/dl. The primary outcome was the proportion of patients who spent at least 50% of the study period within the target range. The consumption of insulin (Cinsulin) and the time to start insulin (Tinsulin) were compared between the two groups. RESULTS: In total, 53 and 51 patients were included and analyzed in the exenatide and control groups, respectively (age: 70 ± 9 vs. 68 ± 11 yr; diabetes mellitus: 12 [23%] vs. 10 [20%]). The primary outcome was observed in 38 (72%) patients in the exenatide group and in 41 (80%) patients in the control group (odds ratio [95% CI] = 0.85 [0.34 to 2.11]; P = 0.30). Cinsulin was significantly lower (60 [40 to 80] vs. 92 [63 to 121] U, P < 0.001), and Tinsulin was significantly longer (12 [7 to 16] vs. 7 [5 to 10] h, P = 0.02) in the exenatide group. CONCLUSIONS: Exenatide alone at the dose used was not enough to achieve adequate blood glucose control in coronary artery bypass grafting patients, but it reduces overall consumption of insulin and increases the time to initiation of insulin.

Impact of Nutritional State on Critical Limb Ischemia Early Outcomes (DENUCRITICC Study).

BACKGROUND: Despite current progress, the prognosis of critical limb ischemia (CLI) remains poor. The ageing of the population, the increasing prevalence of diabetes mellitus, and the stability of tobacco use will increase the prevalence of CLI. CLI patients have risk factors for malnutrition, and the impact of malnutrition on morbidity and mortality has been demonstrated in the general population. However, we have little information on the consequences of undernutrition in the CLI population. The aim of this study is to assess the impact of malnutrition on the early outcomes in CLI patients. METHODS: This is a double-center prospective study that included all consecutive hospitalized patients with CLI. All patients were screened for malnutrition and divided into 2 groups: severe malnourished patients (group A) and moderate malnourished and well-nourished (group B). This distribution was based on age-indexed clinical and biological data and the patient's general condition: the Nutritional Risk Index for patients younger than 75 years, the Mini Nutritional Assessment, or the Geriatric Nutritional Risk Index for those older than 75 years. The primary end point was defined as the rate of 30-day death. Outcomes were compared in a univariate analysis. Stepwise logistic regression was used for the multivariate analysis. Variables with a P value <0.2 in the univariate analysis were introduced in the multivariate model. RESULTS: We included 106 patients. The prevalence of malnutrition was 75.5%, divided into moderate malnutrition (51.9%) and severe malnutrition (23.6%). Six patients (24%) died in group A compared with 8 in group B (4.9%) (P = 0.01). By univariate analysis, severe malnutrition was the only factor associated with death at 30 days. By stepwise logistic regression, severe malnutrition (odds ratio 6.1, 95% confidence interval 1.6-23.7, P = 0.006) was found to be the significant risk factors for death at 30 days. CONCLUSIONS: This study is the first to demonstrate prospectively the major importance of malnutrition in the early prognosis of CLI patients.