Didier Journois

Iatrogenic complications in adult intensive care units : a prospective two-center study

Objectivesa) To evaluate the frequency, types, severity, and morbidity of iatrogenic complications; b) determine associated factors that favor iatrogenic complications; and c) suggest new or more efficient protective measures that may be taken to improve patient safety. DesignProspective, observational study. SettingTwo ICUs in France. Patients and MethodsThe study included 382 patients (age ≥15 yrs; 400 consecutive admissions). Patients were monitored by two physicians in each ICU to assess all iatrogenic complications occurring during their ICU stay, with the exception of adverse effects of drugs. An iatrogenic complication was defined as an adverse event that was independent of the patients underlying disease. ResultsWe observed 316 iatrogenic complications in 124 (31%) of the 400 admissions. Of these iatrogenic complications, 107 (in 53 [13%] of the 400 admissions) complications, were major, three leading to death. Severe hypotension, respiratory distress, pneumothorax, and cardiac arrest represented 78% of the major iatrogenic complications. Fifty-nine percent of the major iatrogenic complications had clearly identified associated factors. Human errors accounted for 67% of these factors. Patients >65 yrs (adjusted odds ratio = 2.6,95% confidence interval: 1.4 to 4.9) and those patients admitted with two or more organ failures (adjusted odds ratio = 4.8, 95% confidence interval: 2.5 to 9.2) were more likely to develop major iatrogenic complications. High or excessive nursing workload also led to an creased risk of major iatrogenic complications Persistent morbidity, secondary to iat complications at the time of discharge, present in five survivors. The risk of ICU dead was about two-fold higher for the patients with major iatrogenic complications than in the re maining patients after adjusting for the Or System Failure Score and the prognosis of the disease (relative risk = 1.92, 95% confidence terval: 1.28 to 2.56). ConclusionsMajor iatrogenic complications were frequent, associated with increased bidity and mortality rates, related to high excessive nursing workload, and were often ondary to human errors. To improve pati safety in our ICUs, preventive measures sho be targeted primarily on the elderly and the most severely ill patients. Special attent should be given to improving the organization workload and training, and promoting w use of noninvasive monitoring. (Crit Care Med 1993; 21:40–51)

High-volume, zero-balanced hemofiltration to reduce delayed inflammatory response to cardiopulmonary bypass in children

Background In previous studies, researchers suggested a beneficial role of hemofiltration performed during cardiopulmonary bypass in children. This study was performed to assess both clinical effects and inflammatory mediator removal by high-volume, zero-fluid balance ultrafiltration during rewarming (Z-BUF). Methods Twenty children undergoing cardiac surgery were assigned randomly to Z-BUF or a control group. Plasma C3a, interleukin (IL)-1, IL-6, IL-8, IL-10, tumor necrosis factor, myeloperoxidase, and leukocyte count were measured before (T1) and after (T2) hemofiltration and 24 h later (T3). The intensive care unit staff was blinded to the patients group. Postoperative alveolar-arterial oxygen gradient, time to extubation, body temperature, and postoperative blood loss were monitored. Results Ultrafiltration rate was 4,972 (3,183-6,218) mL/m2 (median [minimum-maximum]) in the Z-BUF group, where significant reductions were observed in postoperative blood loss, time to extubation (10.8 [9-18] vs. 28.2 [15-58] h) and postoperative alveolar-arterial oxygen gradient (320 [180-418] vs. 551 [485-611] mmHg at T3). In the Z-BUF group, significant removal of tumor necrosis factor, IL-10, myeloperoxidase, and C3a were observed at T2. Interleukin 1, IL-6, IL-8, and myeloperoxidase were decreased at T3, suggesting earlier removal of factor(s) that may trigger their release. Conclusions These results suggest that hemofiltration exerts some beneficial clinical effects that are not due to water removal. The role of the early removal of factors triggering the inflammatory response, rather than a direct removal of cytokines, deserves further investigation.

Hemofiltration during cardiopulmonary bypass in pediatric cardiac surgery. Effects on hemostasis, cytokines, and complement components.

BackgroundThis prospective study was intended to determine in a homogeneous population of children whether hemofiltration, performed during cardiopulmonary bypass rewarming, is able to Improve hemodynamics and biologic hemostasis variables, to reduce postoperative blood loss, time to extubation, and plasma cytokines, and complement fragments. MethodsThirty-two children undergoing surgical correction of tetralogy of Fallot were randomly assigned to a hemofiltration or control group. Hemofiltration was performed with a polysulphone hemofilter during rewarming of cardiopulmonary bypass. Plasma clotting factors, D-dimers, antithrom-bin-III, complement fragments C3a and C5a, interleukin-lβ, interleukln-6, interleukin-8, and tumor necrosis factor-a were measured before and after hemofiltration. Systemic mean arterial pressure, left atrial pressure, time to extubation, and postoperative blood loss were monitored. ResultsIn the hemofiltration group, significant reductions in 24-h blood loss (250 (176–356) vs. 319 (182–500) ml/m2, median (minimum-maximum)), time to extubation (15 (9–22) vs. 19 (11–24) h), plasma concentrations of C3a, C5a, interleukin-6, and tumor necrosis factor-α were observed compared to control. Arterial oxygen tension on admission to the intensive care unit was significantly greater in the hemofiltration group (136 ± 20 vs. 103 ± 25 mmHg, mean ± SD). Significant increases in mean arterial pressure, clotting factors, and antithrombin-III were noted for the hemofiltration group. No intergroup difference was observed in left atrial pressure, platelets count, D-dimers, lnterleukin-8, and duration of stay in the Intensive care unit. ConclusionsHemofiltration during cardiopulmonary bypass in children Improves hemodynamics and early postoperative oxygenatlon and reduces postoperative blood loss and duration of mechanical ventilation. Hemofiltration is able to remove some major mediators of the inflammatory response.

Inhaled nitric oxide as a therapy for pulmonary hypertension after operations for congenital heart defects

Seventeen infants were treated with inhaled nitric oxide for critical pulmonary artery hypertension after operations for congenital heart defects. In all 17 patients conventional medical therapy consisting of hyperventilation, deep sedation/analgesia, and correction of metabolic acidosis had failed. All children were monitored with a transthoracic pulmonary artery catheter inserted at operation. Pulmonary artery hypertension was defined as an acute rise in pulmonary pressure associated with a decrease in oxygen arterial or venous saturation. After failure of conventional medical therapy, 20 ppm of inhaled nitric oxide was administered to the patient. In all patients the pulmonary pressures decreased (mean pulmonary arterial pressure decreased by -34% +/- 21%) without significant change in systemic arterial pressure, whereas the oxygen arterial saturation and oxygen venous saturation increased by 9.7% +/- 12% and 37% +/- 28%, respectively. Fifteen children were discharged from the intensive care unit at 10 +/- 6 days (range 3 to 26 days) and two died. This study demonstrates that inhaled nitric oxide exerts a selective pulmonary vasodilation without decreasing systemic arterial pressure in children with congenital heart disease. The increased values of mixed venous oxygen saturation and urinary output suggest that this selective lowering of pulmonary vascular resistance improved the overall hemodynamics. The potential toxic effects of nitric oxide and nitrogen dioxide necessitate careful consideration of the risks and benefits of inhaled nitric oxide therapy.

Incidence and predictors of major hemorrhagic complications from thrombolytic therapy in patients with massive pulmonary embolism

PURPOSE The risk factors for bleeding in patients receiving recombinant tissue-type plasminogen activator for massive pulmonary embolism are not known. PATIENTS AND METHODS The hospital records of 132 consecutive patients who received recombinant tissue-type plasminogen activator for massive pulmonary embolism were retrospectively reviewed. Bleeding was estimated by using the bleeding severity index, a method previously validated in patients receiving anticoagulants. Multivariate stepwise logistic regression was used to identify independent risk factors for bleeding. Four other definitions of bleeding in large pulmonary embolism thrombolytic trials were also used, and the agreement among these criteria was assessed. RESULTS According to the bleeding severity index, 33 patients (25%) had one or more major bleeding complications. Hemorrhage at the venous puncture site for angiography was the most frequent complication (15 patients, 11%). Major bleeding at the catheterization site was more common at the femoral site (14 of 63 patients = 22%) than at the brachial site (1 of 63 patients = 2%; P = 0.0004). The use of the five different bleeding definitions resulted in a variation in the major bleeding rate from 3% to 43%. The kappa coefficient varied from 0.07 to 0.84, indicating poor agreement between most of the classifications. CONCLUSION The use of the femoral vein for pulmonary angiography was the only variable significantly associated with major bleeding. Most of the differences observed in the pulmonary embolism thrombolytic trials are likely related to the differences in the definition of bleeding rather than to the thrombolytic regimen.

Ten-year experience with surgical treatment of partial atrioventricular septal defect: Risk factors in the early postoperative period

Partial atrioventricular septal defects are electively repaired with good results. However, recent reports suggest that such repair is potentially a high-risk surgical procedure. Our aim was to determine the risk factors of adverse outcome early after surgical treatment of atrioventricular septal defects in our hospital. A retrospective study was done in 100 consecutive patients from 2 months to 50.6 years old (median 3.6 years) who underwent surgical correction between January 1984 and December 1993. An intermediate form of the lesion was noted in 31% of cases. Congestive heart failure occurred in 50% of cases. Preoperative left atrioventricular valve incompetence (moderate to severe) was present in 63% of patients. Severe abnormalities of left subvalvular apparatus were noted in 28% of patients. The cleft of the left atrioventricular valve was closed in 76% of cases. The study was done to determine risk factors associated with hospital mortality (13%), postoperative residual left atrioventricular valve incompetence (23%), and early reoperation (14%) within the first 30 postoperative days. Univariate analysis showed that age at the date of operation and cleft closure were not related to an early adverse outcome. A stepwise logistic regression with variables selected by univariate analysis identified infections and severe abnormalities of left subvalvular apparatus as predictive factors of early death (odds ratio, 28.07 and 6.18, respectively), preoperative left atrioventricular valve regurgitation as a predictive factor of residual postoperative left atrioventricular valve regurgitation (odds ratio, 5.34), and severe abnormalities of left subvalvular apparatus as a predictive factor of early reoperation (odds ratio, 5.27). These results emphasize the importance of the severity of the morphologic features of the left subvalvular apparatus, the occurrence of early postoperative infections, and the presence of residual left atrioventricular valve regurgitation as risk factors in the early period after surgical correction of partial atrioventricular septal defects.

Assessment of coagulation factor activation during cardiopulmonary bypass with a new monoclonal antibody

Antithrombin-III (AT) is a key inhibitor of blood coagulation that neutralizes activated serine esterases by forming covalent modified complexes (ATm). A new monoclonal antibody directed against short-lived AT-activated serine protease complexes provides a means of measuring subclinical coagulation activity during cardiopulmonary bypass (CPB). Twelve patients undergoing CPB for coronary artery bypass grafting were studied and AT, ATm, D-dimers (DD), and several other coagulation and fibrinolytic markers were measured during the surgical procedure. There were decreases in AT, factors V, II, X, IX, protein S (total and free), C4b-binding protein, thrombomodulin, and platelets counts, whereas heparin, ACT, thrombospondin, plasminogen activator inhibitor (PAI-1), and tissue plasminogen activator (tPA) increased. ATm and the percentage of ATm available (ATm/AT) showed a peak during CPB. These results demonstrate that during CPB, the use of heparin produces an equilibrium involving increased coagulation activation and consumption in association with increased fibrinolysis. The equilibrated consumption of both coagulation and fibrinolytic factors leads to low levels of all factors after cardiac surgery. The ATm assay allows assessment of the differential effects of CPB and surgical trauma on coagulation activation. It is speculated that ATm levels may be useful in monitoring the consumption of coagulation factors.

Extracorporeal life support (ECLS) for refractory cardiac arrest after drowning: an 11-year experience.

AIM Neuroprotective effects of hypothermia may explain surprisingly high survival rates reported after drowning in cold water despite prolonged submersion. We described a cohort of refractory hypothermic cardiac arrests (CA) due to drowning treated by extracorporeal life support (ECLS) and aimed to identify criteria associated with 24-h survival. METHODS Eleven-year period (2002-2012) retrospective study in the surgical intensive care unit (ICU) of a tertiary hospital (European Hospital Georges Pompidou, Paris, France). All consecutive hypothermic patients admitted for refractory CA after drowning in the Seine River were included. Patients with core temperature below 30°C and submersion duration of less than 1h were potentially eligible for ECLS resuscitation. RESULTS Forty-three patients were admitted directly to the ICU during the study period. ECLS was initiated in 20 patients (47%). Among these 20 patients, only four (9%) survived more than 24h. A first hospital core temperature ≤26°C and a potassium serum level between 4.2 and 6mM at hospital admission have a sensitivity of 100% [95%CI: 28-100%] and a specificity of 100% [95%CI: 71-100%] to discriminate patients who survived more than 24h. Overall survival at ICU discharge and at 6-months was 5% [95%CI: 1-16%] (two patients). CONCLUSIONS Despite patient hypothermia and aggressive resuscitation with ECLS, the observed survival rate is low in the present cohort. Like existing algorithms for ECLS management in avalanche victims, we recommend to use first core temperature and potassium serum level to indicate ECLS for refractory CA due to drowning.

Factors associated with early graft dysfunction in cystic fibrosis patients receiving primary bilateral lung transplantation

OBJECTIVES Primary graft dysfunction (PGD) occurs in 10-25% of cases and remains responsible for significant morbidity and mortality after lung transplantation. Our goal was to explore donor and recipient variables and procedure factors that could be related to early graft failure in cystic fibrosis patients receiving bilateral lung transplantation, the PGD grade being derived from the PaO(2)/FiO(2) ratio measured at the sixth post-operative hour. METHODS Data from 122 cystic fibrosis patients having undergone lung transplantation in six transplant centres in France were retrospectively analysed. Donor and recipient variables, procedure characteristics and anaesthesia management items were recorded and analysed with regard to the PaO(2)/FiO(2) ratio at the sixth post-operative hour. Recipients were divided into three groups according to this ratio: Grade I PGD, when PaO(2)/FiO(2) >300 mmHg or extubated patients, Grade II, when PaO(2)/FiO(2) = 200-300 mmHg, and Grade III, when PaO(2)/FiO(2) <200 mmHg or extracorporeal membrane oxygenation still required. RESULTS Forty-eight patients were Grade I, 32 patients Grade II and 42 patients Grade III PGD. Otos donor score, recipient variables and procedure characteristics were not statistically linked to PaO(2)/FiO(2) at the sixth post-operative hour. Ischaemic time of the last implanted graft and the lactate level at the end of the procedure are the only factors related to Grade III PGD in this group. CONCLUSIONS Hyperlactataemia most probably reflects the severity of early PGD, which leaves graft ischaemic time as the only factor predicting early PGD in a multicentre population of cystic fibrosis lung graft recipients.

Continuous Intercostal Blockade With Lidocaine After Thoracic Surgery

The efficacy and the side effects of a continuous infusion of lidocaine in the fifth intercostal space for the management of postoperative pain after lateral thoracotomy were evaluated in 20 adults. An indwelling catheter was inserted in the appropriate intercostal space before thoracotomy closure. After recovery from general anesthesia, a loading dose of 3 mg/kg of 1.5% lidocaine with epinephrine 1:160,000 was injected through the catheter, followed by a continuous infusion of 1% lidocaine without epinephrine at a rate of 1 mg.kg−1 for 54 h. In seven patients pharmacokinetic data were obtained. Pain, assessed by visual continuous analog scale, decreased from a median score of 8 (range, 7--10) to a score of 5 (range, 2--7) 20 min after the loading dose of lidocaine and continued to decrease until the end of the study (P = 0.0001). Complete cutaneous analgesia, assessed by pinprick test, was seen in a median of three thoracic spinal segments (range, 0--6) with partial cutaneous analgesia in seven segments (range, 6--9) 40 min after the loading dose, and levels that remained unchanged for 54 h (P = 0.0001). Peak lidocaine serum concentrations, 1.9 ± 0.7 ±g/mL, were present 9 ± 3 min after injection of the loading dose. Serum concentrations of lidocaine under steady state conditions averaged 4.8 ± 0.9 μg/mL (range, 3.5--5.8 μg/mL). This level under steady state conditions, though below the toxic level, suggests that additional bolus injection of lidocaine during the course of infusion might result in potentially toxic serum levels of lidocaine. Our data show that the intercostal infusion of lidocaine in a single intercostal segment after thoracotomy provides prompt, prolonged, and effective analgesia, without side effects and with a pharmacokinetic profile indicating that serum levels remain below toxic threshold values.