Potentially Severe Incidents During Interhospital Transport of Critically Ill Patients, Frequently Occurring But Rarely Reported: A Prospective Study

Objectives The out-of-hospital environment can pose significant challenges to the quality and safety of interhospital transport of critically ill patients. Because we lack knowledge of the occurrence of incidents, their potential consequences, and whether they are actually reported, this study was initiated. Methods Two different services in Norway were asked to self-report incidents after every interhospital transport of critically ill patients. Sampling lasted for 12 and 8 months, respectively. An expert group evaluated each incident for severity and demand for reporting into the hospital’s electronic incident reporting system. One year later, the hospital’s reporting system was scrutinized to determine the number of incidents actually reported. Results A total of 455 transports of critically ill patients were performed, resulting in 294 unique incidents reported: medical (15%), technical (25%), missing equipment (17%), and personal failures and communication difficulties (42%). Only 3 (1%) of the 294 unique incidents were actually reported in the hospital’s electronic incident reporting system. The experts were inconsistent in which incidents should have been reported and to what degree checklists, standard operating procedures, simulation, and training could have prevented the incidents. Conclusions This study of interhospital transports of critically ill patients reveals a very high number of incidents. Despite this fact, these incidents are severely underreported in the hospital’s electronic incident reporting system. This suggests that learning is lost and errors with predominant probability are repeated. These results emphasize the existing challenges in regard to the quality and safety of interhospital transport of critically ill patients.publishedVersio

Pharmaceutical-grade albumin: impaired drug-binding capacity in vitro

BACKGROUND: Albumin is the most abundant protein in blood plasma, and due to its ligand binding properties, serves as a circulating depot for endogenous and exogenous (e.g. drugs) compounds. Hence, the unbound drug is the pharmacologically active drug. Commercial human albumin preparations are frequently used during surgery and in critically ill patients. Recent studies have indicated that the use of pharmaceutical-grade albumin is controversial in critically ill patients. In this in vitro study we investigated the drug binding properties of pharmaceutical-grade albumins (Baxter/Immuno, Octapharma, and Pharmacia & Upjohn), native human serum, and commercially available human serum albumin from Sigma Chemical Company. METHODS: The binding properties of the various albumin solutions were tested in vitro by means of ultrafiltration. Naproxen, warfarin, and digitoxin were used as ligands. HPLC was used to quantitate the total and free drug concentrations. The data were fitted to a model of two classes of binding sites for naproxen and warfarin and one class for digitoxin, using Microsoft Excel and Graphpad Prism. RESULTS: The drugs were highly bound to albumin (95–99.5%). The highest affinity (lowest K(1)) was found with naproxen. Pharmaceutical-grade albumin solutions displayed significantly lower drug-binding capacity compared to native human serum and Sigma albumin. Thus, the free fraction was considerably higher, approximately 40 times for naproxen and 5 and 2 times for warfarin and digitoxin, respectively. The stabilisers caprylic acid and N-acetyl-DL-tryptophan used in the manufacturing procedure seem to be of importance. Adding the stabilisers to human serum and Sigma albumin reduced the binding affinity whereas charcoal treatment of the pharmaceutical-grade albumin from Octapharma almost restored the specific binding capacity. CONCLUSION: This in vitro study demonstrates that the specific binding for warfarin and digitoxin is significantly reduced and for naproxen no longer detectable in pharmaceutical-grade albumin. It further shows that the addition of stabilisers may be of major importance for this effect

Experience of unpleasant sensations in the mouth after injection of saline from prefilled syringes

Background Nurses at The Norwegian Radium Hospital have reported that some patients notice an unpleasant smell or taste in accordance with flushing of intravenous lines with commercially available prefilled syringes. We have conducted a study in healthy volunteers to investigate the occurrence, consistency and intensity of this phenomenon. Methods A randomised, blinded, crossover study comparing commercial available prefilled saline 9 mg/ml syringes to saline 9 mg/ml for injection in polyethylene package was performed in 10 healthy volunteers. The volunteers were given intravenous injections of varying volume and speed. Data were analysed using descriptive statistics, and also Wilcoxon Signed Rank Test to compare groups. Results After intravenous injection, 2 of 15 recordings demonstrated any sensation of smell or taste after injection of saline from polyethylene package, while 14 of 15 recordings noted a sensation after injection of saline from prefilled syringes. The intensity of the unpleasant sensation was rated significantly higher after injection of saline from prefilled syringes compared to saline from polyethylene (p = 0.001). Conclusions Injection of saline from prefilled syringes in healthy volunteers resulted in an experience of bad taste or smell. It is important that nurses and health workers are aware of the phenomenon as described in this article in order to choose the preferred product for a given patient

Robot-assisted laparoscopic prostatectomy in a 68-year-old patient with previous heart transplantation and pelvic irradiation

We report the case of a 68-year-old man who had previously undergone heart transplantation and pelvic irradiation for Hodgkin’s lymphoma and who was under active surveillance for prostate cancer. In response to his increased prostate-specific antigen levels and elevated Gleason score, he was offered robot-assisted laparoscopic prostatectomy

A randomized placebo-controlled phase II study of clarithromycin or placebo combined with VCD induction therapy prior to high-dose melphalan with stem cell support in patients with newly diagnosed multiple myeloma

Abstract Background The objective of this randomized placebo-controlled study was to investigate the efficacy and safety of clarithromycin in combination with bortezomib–cyclophosphamide–dexamethasone (VCD) in patients with newly diagnosed multiple myeloma eligible for high-dose therapy. Methods Patients were randomized to receive tablet clarithromycin 500 mg or matching placebo tablet twice daily during the first 3 cycles of VCD induction therapy. Primary endpoint was to compare the rate of very good partial response (VGPR) or better response after three cycles of VCD combined with clarithromycin or placebo. Results The study was prematurely stopped for safety reasons after the inclusion of 58 patients (36% of the planned study population). The patients were randomly assigned to clarithromycin (n = 27) or placebo (n = 31). VGPR or better response after the VCD induction therapy was obtained in 12 patients (44.4%, 95% CI 25.5–64.7) and in 16 patients (51.6%, 33.1–69.8) (p = 0.59) in the clarithromycin group and the placebo group, respectively. Seven patients (25.9%) in the clarithromycin group developed severe gastrointestinal complications (≥ grade 3) comprising pain, neutropenic enterocolitis, paralytic ileus or peptic ulcer. These complications occurred in only one patient in the placebo group. Septicemia with Gram negative bacteria was observed in 5 patients in the clarithromycin group in contrast to one case of pneumococcal septicemia in the placebo group. Patient-reported QoL were negatively affected in the clarithromycin group compared to the placebo group. Conclusion The study was prematurely stopped due to serious adverse events, in particular serious gastrointestinal complications and septicemia. The response data do not suggest any effect of clarithromycin when added to the VCD regimen. The combination of clarithromycin and bortezomib containing regimens is toxic and do not seem to offer extra anti-myeloma efficacy. Trial registration EudraCT (no. 2014-002187-32, registered 7 October 2014, https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-002187-32/DK) and ClinicalTrials.gov (no NCT02573935, retrospectively registered 12 October 2015, https://www.clinicaltrials.gov/ct2/show/NCT02573935?term=Gregersen&cntry=DK&rank=9

Dynamic assessment of the pupillary reflex in patients on high-dose opioids

Background and aims Pupil size and reaction are influenced by opioids, an effect that is not considered to be affected by opioid tolerance. As clinicians have observed patients on high-dose opioids who exhibited seemingly normal pupil sizes, we wanted to dynamically assess the pupillary reflex in cancer patients on high-dose opioids. Methods We performed a dynamic assessment of the pupillary reflex in cancer patients on high-dose opioids and a control group of healthy volunteers using a portable, monocular, infrared pupillometer. We also performed a clinical examination and measured blood concentrations of opioids and their active metabolites. Results Sixty three patients who were on opioids for 2 months (median time) and on an oral morphine equivalent dose of 250 mg (median dose) were investigated. Most patients used more than one opioid. When correcting for age, pupil size in the group that had received no increase of opioid dose over the last 14 days was not significantly different from pupil size in the healthy volunteer group (p = 0.76), while the group that had increased the dose of opioids differed significantly from healthy volunteers (p = 0.006). We found no statistically significant correlation between total oral morphine equivalents and pupillary reactions or between blood opioid or opioid metabolite concentrations and baseline pupillary changes. Conclusion Pupillary changes do take place in patients on opioids. However, tolerance to these changes occurs when medication is not increased over time. Dynamic pupillometry can give additional information about the degree of tolerance to opioids. Implications These findings elucidate previous misconceptions regarding pupillary effects and tolerance to opioids

A patient with solid gynecologic cancer causing lactic acidosis, severe hypercalcemia, and hypoglycemia

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Potentially Severe Incidents During Interhospital Transport of Critically Ill Patients, Frequently Occurring But Rarely Reported: A Prospective Study

Objectives The out-of-hospital environment can pose significant challenges to the quality and safety of interhospital transport of critically ill patients. Because we lack knowledge of the occurrence of incidents, their potential consequences, and whether they are actually reported, this study was initiated. Methods Two different services in Norway were asked to self-report incidents after every interhospital transport of critically ill patients. Sampling lasted for 12 and 8 months, respectively. An expert group evaluated each incident for severity and demand for reporting into the hospital’s electronic incident reporting system. One year later, the hospital’s reporting system was scrutinized to determine the number of incidents actually reported. Results A total of 455 transports of critically ill patients were performed, resulting in 294 unique incidents reported: medical (15%), technical (25%), missing equipment (17%), and personal failures and communication difficulties (42%). Only 3 (1%) of the 294 unique incidents were actually reported in the hospital’s electronic incident reporting system. The experts were inconsistent in which incidents should have been reported and to what degree checklists, standard operating procedures, simulation, and training could have prevented the incidents. Conclusions This study of interhospital transports of critically ill patients reveals a very high number of incidents. Despite this fact, these incidents are severely underreported in the hospital’s electronic incident reporting system. This suggests that learning is lost and errors with predominant probability are repeated. These results emphasize the existing challenges in regard to the quality and safety of interhospital transport of critically ill patients