Demetrios J. Kutsogiannis

Family satisfaction with care in the intensive care unit: results of a multiple center study.

Objective To determine the level of satisfaction of family members with the care that they and their critically ill relative received. Design Prospective cohort study. Setting Six university-affiliated intensive care units across Canada. Methods We administered a validated questionnaire to family members who made at least one visit to intensive care unit patients who received mechanical ventilation for >48 hrs. We obtained self-rated levels of satisfaction with 25 key aspects of care related to the overall intensive care unit experience, communication, and decision making. For family members of survivors, the questionnaire was administered while the patient was still in the hospital. For family members of nonsurvivors, the questionnaire was mailed out to the family member 3–4 wks after the patient’s death. Main Results A total of 891 family members received questionnaires; 624 were returned (70% response rate). The majority of respondents were satisfied with overall care and with overall decision making (mean ± sd item score, 84.3 ± 15.7 and 75.9 ± 26.4, respectively). Families reported the greatest satisfaction with nursing skill and competence (92.4 ± 14.0), the compassion and respect given to the patient (91.8 ± 15.4), and pain management (89.1 ± 16.7). They were least satisfied with the waiting room atmosphere (65.0 ± 30.6) and frequency of physician communication (70.7 ± 29.0). The variables significantly associated with overall satisfaction in a regression analysis were completeness of information received, respect and compassion shown to the patient and family member, and the amount of health care received. Satisfaction varied significantly across sites. Conclusions Most family members were highly satisfied with the care provided to them and their critically ill relative in the intensive care unit. Efforts to improve the nature of interactions and communication with families are likely to lead to improvements in satisfaction.

A randomized, double-blind, placebo-controlled, Phase 2b study to evaluate the safety and efficacy of recombinant human soluble thrombomodulin, ART-123, in patients with sepsis and suspected disseminated intravascular coagulation.

Objectives:To determine the safety and efficacy of recombinant thrombomodulin (ART-123) in patients with suspected sepsis-associated disseminated intravascular coagulation. Design:Phase 2b, international, multicenter, double-blind, randomized, placebo-controlled, parallel group, screening trial. Setting:Two hundred and thirty-three ICUs in 17 countries. Patients:All adult patients admitted with sepsis and suspected disseminated intravascular coagulation as assessed using a modified International Society on Thrombosis and Hemostasis score. Interventions:Patients were randomized to receive IV ART-123 (0.06 mg/kg/d) for 6 days or placebo, in addition to standard of care. The primary endpoint was reduction in mortality. Secondary endpoints included reversal of overt disseminated intravascular coagulation and reduction in disease severity. Measurements and Main Results:A total of 750 patients were randomized, nine of whom did not receive the allocated treatment so that 371 patients received ART-123 and 370 received placebo. There were no meaningful differences between the two groups in any of the baseline variables. Twenty-eight-day mortality was 17.8% in the ART-123 group and 21.6% in the placebo group (Cochran–Mantel–Haenszel two-sided p value of 0.273 in favor of ART-123, which met the predefined statistical test for evidence suggestive of efficacy). There were no statistically significant differences in event-free and alive days between the two groups. d-dimer, prothrombin fragment F1.2 and TATc concentrations were lower in the ART-123 group than in the placebo group. There were no differences between the two groups in organ function, inflammatory markers, bleeding or thrombotic events or in the development of new infections. In post hoc analyses, greatest benefit from ART-123 was seen in patients with at least one organ system dysfunction and an international normalized ratio greater than 1.4 at baseline. Conclusions:ART-123 is a safe intervention in critically ill patients with sepsis and suspected disseminated intravascular coagulation. The study provided evidence suggestive of efficacy supporting further development of this drug in sepsis-associated coagulopathy including disseminated intravascular coagulation. Future study should focus on using ART-123 in the subgroup of patients most likely to respond to this agent.

Medical management to optimize donor organ potential: review of the literature.

PurposeOver the past two decades, the demand for donor organs continues to outpace the number of organs available for transplantation. Parallel with this has been a change in the demographics of organ donors with an increase in older donors and donors with marginal organs as a proportion of the total organ donor pool. Consequently, efforts have been made to improve the medical care delivered to potential organ donors to improve the conversion rate and graft survival of available organs. The purpose of this literature review is to provide updated recommendations for the contemporary management of organ donors after the neurological determination of death in order to maximize the probability of recipient graft survival.SourcesA comprehensive review of the literature obtained through searches of MEDLINE/PubMed, and personal reference files.Principal findingsContemporary management of the organ donor after neurological determination of death includes therapies to prevent the detrimental effects of the autonomic storm, the use of invasive hemodynamic monitoring and aggressive respiratory therapy including therapeutic bronchoscopy in marginal heart and lung donors, and the use of hormonal therapy including vasopressin, corticosteroids, triiodothyronine or thyroxine, and insulin for the pituitary failure and inflammation seen in brain dead organ donors. The importance of normalizing donor physiology to optimize all available organs is stressed.ConclusionAggressive hemodynamic and respiratory management of solid organ donors, coupled with the use of hormonal therapy improves the rate of conversion and graft survival in solid organ recipients.RésuméObjectifDepuis plus de deux décennies, il y a une disproportion croissante entre les demandes de transplantation et la pénurie d’organes disponibles. En même temps, les données démographiques des donneurs ont changé, car une partie de leur nombre total compte plus de gens âgés dont les organes sont marginaux. Par conséquent, on tente d’améliorer les soins médicaux prodigués aux donneurs potentiels pour augmenter le taux de conversion et la survie du greffon des organes disponibles. Notre revue visait la mise à jour de recommandations de traitement aux donneurs d’organes, chez qui la mort neurologique a été établie, pour maximiser la probabilité de survie du greffon chez le receveur.SourcesUne revue documentaire étendue obtenue par des recherches dans MEDLINE/PubMed et des fichiers de référence personnels.Constatations principalesLe traitement actuel du donneur d’organe, après la détermination de la mort neurologique, comprend la prévention d’effets nuisibles du choc subi par le système nerveux autonome, l’usage d’un monitorage hémodynamique effractifet une thérapie respiratoire énergique dont la bronchoscopie thérapeutique chez des donneurs marginaux de cœur et de poumons et l’usage d’hormonothérapie dont la vasopressine, les corticostéroïdes, la triiodothyronine ou thyroxine et l’insuline pour la défaillance hypophysaire et l’inflammation observée lors de la mort encéphalique des donneurs. L’accent est mis sur la normalisation physiologique du donneur afin de mieux protéger tout organe disponible.ConclusionLe traitement hémodynamique et respiratoire énergique des donneurs d’organes pleins, couplé à l’usage d’hormonothérapie, améliore le taux de conversion et la survie du greffon chez les receveurs.

Defining priorities for improving end-of-life care in Canada

Background: High-quality end-of-life care should be the right of every Canadian. The objective of this study was to identify aspects of end-of-life care that are high in priority as targets for improvement using feedback elicited from patients and their families. Methods: We conducted a multicentre, cross-sectional survey involving patients with advanced, life-limiting illnesses and their family caregivers. We administered the Canadian Health Care Evaluation Project (CANHELP) questionnaire along with a global rating question to measure satisfaction with end-of-life care. We derived the relative importance of individual questions on the CANHELP questionnaire from their association with a global rating of satisfaction, as determined using Pearson correlation coefficients. To determine high-priority issues, we identified questions that had scores indicating high importance and low satisfaction. Results: We approached 471 patients and 255 family members, of whom 363 patients and 193 family members participated, with response rates of 77% for patients and 76% for families. From the perspective of patients, high-priority areas needing improvement were related to feelings of peace, to assessment and treatment of emotional problems, to physician availability and to satisfaction that the physician took a personal interest in them, communicated clearly and consistently, and listened. From the perspective of family members, similar areas were identified as high in priority, along with the additional areas of timely information about the patient’s condition and discussions with the doctor about final location of care and use of end-of-life technology. Interpretation: End-of-life care in Canada may be improved for patients and their families by providing better psychological and spiritual support, better planning of care and enhanced relationships with physicians, especially in aspects related to communication and decision-making.

Bacteremia, acute physiology and chronic health evaluation II and modified end stage liver disease are independent predictors of mortality in critically ill nontransplanted patients with acute on chronic liver failure

Objectives:To determine what physiological and biochemical factors predict development of bacteremia in nontransplanted patients with acute on chronic liver failure and, on diagnosis of bacteremia, what is the natural history of bacteremic patients versus control subjects (acute on chronic liver failure). Interventions:None. Design:Retrospective analysis of data collected prospectively and entered into a dedicated physiology database. Setting:Specialist liver intensive therapy unit. Patients:Critically ill non-transplanted patients with acute on chronic liver failure admitted between January 2003 and July 2005. Measurements and Main Results:One hundred eighty-four patients were defined with acute on chronic liver failure; 67 (36%) had bacteremia. One hundred seventeen (64%) patients did not (acute on chronic liver failure). Fifty-eight percent of isolates were Gram-negative organisms, 36% were Gram-positives, and 6% fungemia. Median time to first bacteremia was 8 days (range, 3–12 days). On admission (univariate), bacteremic patients had significantly higher Modified End Stage Liver Disease scores (27 vs. 24, p = .037), Acute Physiology and Chronic Health Evaluation II scores (23 vs. 21, p = .049), and greater degrees of encephalopathy (Glasgow Coma Scale score 10 vs. 12, p = .001). During their liver intensive therapy unit course, bacteremic patients had significantly greater requirements for renal replacement therapy (64% vs. 49%, p = .043), mechanical ventilation (88% vs. 68%, p = .002), and a longer median liver intensive therapy unit stay (16 vs. 5 days, p < .001). Survival to hospital discharge was worse in the bacteremic group (25% vs. 56%, p < .001). Multivariate analysis (logistic regression) was performed separately modeling with Acute Physiology and Chronic Health Evaluation II and Modified End Stage Liver Disease. In the first model, Acute Physiology and Chronic Health Evaluation II (odds ratio 1.24) and bacteremia (2.24) were independent predictors of mortality. In the later model, Modified End Stage Liver Disease (odds ratio, 1.06), requirement for renal replacement therapy (3.08), Glasgow Coma Scale (0.72), and bacteremia (2.30) were significant. Both models performed similarly (Modified End Stage Liver Disease area under the receiver operating characteristic curve, 0.864; Acute Physiology and Chronic Health Evaluation II, 0.862). Conclusions:In nontransplanted patients with acute on chronic liver failure, bacteremia was associated with increased severity of illness on admission, greater requirements for organ support, and independently adversely impacted on survival. Higher Acute Physiology and Chronic Health Evaluation II and Modified End Stage Liver Disease scores were also independently predictive of mortality.

Bedside ultrasound is a practical and reliable measurement tool for assessing quadriceps muscle layer thickness.

BACKGROUND Critically ill patients commonly experience skeletal muscle wasting that may predict clinical outcome. Ultrasound is a noninvasive method that can measure muscle quadriceps muscle layer thickness (QMLT) and subsequently lean body mass (LBM) at the bedside. However, currently the reliability of these measurements are unknown. The objectives of this study were to evaluate the intra- and interreliability of measuring QMLT using bedside ultrasound. METHODS Ultrasound measurements of QMLT were conducted at 7 centers on healthy volunteers. Trainers were instructed to perform measurements twice on each patient, and then a second trainee repeated the measurement. Intrarater reliability measured how consistently the same person measured the subject according to intraclass correlation (ICC). Interrater reliability measured how consistently trainer and trainee agreed when measuring the same subject according to the ICC. RESULTS We collected 42 pairs of within operator measurements with an ICC of .98 and 78 pairs of trainer-to-trainee measurements with an ICC of .95. There were no statistically significant differences between the trainer and trainee results (trainer and trainee mean = -0.028 cm, 95% CI = -0.067 to -0.011, P = .1607). CONCLUSIONS Excellent intra- and interrater reliability for ultrasound measurements of QMLT in healthy volunteers was observed when performed by a range of providers with no prior ultrasound experience, including dietitians, nurses, physicians, and research assistants. This technique shows promise as a method to evaluate LBM status in ICU or hospital settings and as a method to assess the effects of nutrition and exercise-based interventions on muscle wasting.

Drotrecogin alfa (activated) in patients with severe sepsis presenting with purpura fulminans, meningitis, or meningococcal disease: a retrospective analysis of patients enrolled in recent clinical studies

IntroductionWe report data from adult and pediatric patients with severe sepsis from studies evaluating drotrecogin alfa (activated) (DrotAA) and presenting with purpura fulminans (PF), meningitis (MEN), or meningococcal disease (MD) (PF/MEN/MD). Such conditions may be associated with an increased bleeding risk but occur in a relatively small proportion of patients presenting with severe sepsis; pooling data across clinical trials provides an opportunity for improving the characterization of outcomes.MethodsA retrospective analysis of placebo-controlled, open-label, and compassionate-use trials was conducted. Adult patients received infusions of either DrotAA or placebo. All pediatric patients (<18 years old) received DrotAA. 189 adult and 121 pediatric patients presented with PF/MEN/MD.ResultsFewer adult patients with PF/MEN/MD met cardiovascular (68.3% versus 78.8%) or respiratory (57.8% versus 80.5%) organ dysfunction entry criteria than those without. DrotAA-treated adult patients with PF/MEN/MD (n = 163) had an observed 28-day mortality rate of 19.0%, a 28-day serious bleeding event (SBE) rate of 6.1%, and an intracranial hemorrhage (ICH) rate of 4.3%. Six of the seven ICHs occurred in patients with MEN (three of whom were more than 65 years old with a history of hypertension). DrotAA-treated adult patients without PF/MEN/MD (n = 3,088) had an observed 28-day mortality rate of 25.5%, a 28-day SBE rate of 5.8%, and an ICH rate of 1.0%. In contrast, a greater number of pediatric patients with PF/MEN/MD met the cardiovascular organ dysfunction entry criterion (93.5% versus 82.5%) than those without. DrotAA-treated PF/MEN/MD pediatric patients (n = 119) had a 14-day mortality rate of 10.1%, an SBE rate of 5.9%, and an ICH rate of 2.5%. DrotAA-treated pediatric patients without PF/MEN/MD (n = 142) had a 14-day mortality rate of 14.1%, an SBE rate of 9.2%, and an ICH rate of 3.5%.ConclusionDrotAA-treated adult patients with severe sepsis presenting with PF/MEN/MD had a similar SBE rate, a lower observed 28-day mortality rate, and a higher observed rate of ICH than DrotAA-treated patients without PF/MEN/MD. DrotAA-treated pediatric patients with severe sepsis with PF/MEN/MD may differ from adults, because all three outcome rates (SBE, mortality, and ICH) were lower in pediatric patients with PF/MEN/MD.

Predictors of bacteraemia and mortality in patients with acute liver failure

PurposeTo determine what physiological and biochemical factors predict development of bacteraemia and mortality in patients with acute liver failure (ALF).MethodsRetrospective analysis of 206 ALF patients admitted to a specialist liver intensive therapy unit (LITU) from January 2003 to July 2005 (data collected prospectively).ResultsA total of 206 patients were defined with ALF: 72 (35%) suffered bacteraemia (BAClf) and 134 (65%) did not (NBAClf). Gram positive organisms were observed in 44% of isolates, gram negatives in 52% and fungaemia in 4%. Median time to first bacteraemia was 10 (7–16) days. On admission, BAClf patients had higher SIRS scores and degrees of hepatic encephalopathy (HE). During their LITU course, BAClf patients had significantly increased requirements for renal replacement therapy (RRT), mechanical ventilation, and longer median LITU stay. Multivariate analysis (logistical regression) demonstrated significant predictors of bacteraemia on admission were HE grade >2 (Odds Ratio 1.6) and SIRS score >1 (OR 2.7). In all patients, independent predictors of mortality (logistical) were age (OR 1.41), maximum HE grade pre-intubation (1.76), Lactate (1.14) and Acute Physiology and Chronic Health Evaluation II score (APACHEII) (1.09), but not bacteraemia. Transplantation was protective (OR 0.20).ConclusionIn this study, severity of hepatic encephalopathy and SIRS score >1 were predictive of bacteraemia. APACHEII was independently predictive of mortality in all ALF patients but not bacteraemia.

Most critically ill patients are perceived to die in comfort during withdrawal of life support: a Canadian multicentre study.

PurposeMost deaths in intensive care units (ICUs) follow a withdrawal of life support (LS). Evaluation of this process including the related perspectives of grieving family members is integral to improvement of palliation in the ICU.MethodsA prospective, multicentre, cohort study in six Canadian university-affiliated ICUs included 206 ICU patients (length of stay ≥ 48 hr) who received mechanical ventilation (MV) before LS withdrawal. We recorded modes, sequence and time course of LS withdrawal and drug usage (4 hr before; 4–8 hr and 8–12 hr before death). We asked a specified family member to assess patient comfort and key aspects of end-of life care.ResultsMV was withdrawn from 155/206 (75.2%) patients; 97/155 (62.6%) died after extubation and 58/155 (37.4%) died with an airway in place. The most frequently used drugs and the cumulative doses [median (range)] in the four hours before death were: morphine 119/206, 24 mg, (2–450 mg); midazolam 45/206, 24 mg, (2–380 mg); and lorazepam 35/206, 4 mg, (1–80 mg). These doses did not differ among the three time periods before death. Of 196 responses from family members most indicated that patients were perceived to be either totally (73, 37.2%), very (48, 24.5%), or mostly comfortable (58, 29.6%). Times to death, morphine use and family members’ perceptions of comfort were similar for each type of change to MVConclusionsMost patients were perceived by family members to die in comfort during a withdrawal of LS. Perceptions of patient comfort and drug use in the hours before death were not associated with the mode or sequence of withdrawal of LS, or the time to death.RésuméObjectifLa plupart des décès qui surviennent dans les unités de soins intensifs (USI) suivent le retrait du maintien de la survie (MS). L’évaluation de cette situation, y compris les perspectives reliées à la peine des membres de la famille, est indispensable pour améliorer les soins palliatifs à l’USI.MéthodeUne étude de cohorte prospective multicentrique de six USI canadiennes d’affiliation universitaire comportait 206 patients de l’USI (séjour de = 48 h) qui ont reçu une ventilation mécanique (VM) avant le retrait du MS. Nous avons noté les modes de retrait du MS, leur séquence et leur évolution et l’usage de médicaments (4 h avant; 4–8 h et 8–12 h avant la mort). Nous avons demandé à un membre de la famille en particulier d’évaluer le confort du patient et les aspects clés des soins palliatifs.RésultatsLa VM a été retirée pour 155/206 (15,2 %) patients; 97/155 (62,6 %) sont décédés après l’extubation et 58/155 (37,4 %) avec une intubation en place. Les médicaments les plus utilisés et les doses cumulatives [médiane (valeurs extrêmes)] des quatre heures précédant le décès ont été: la morphine 119/206, 24 mg, (2–450 mg); le midazolam 45/206, 24 mg, (2–380 mg) et le lorazépam 35/206, 4 mg, (1–80 mg). Ces doses étalent similaires pour les trois périodes de temps avant la mort. Des 196 réponses des membres des familles, la majorité Indiquait que les patients semblaient bénéficier d’un confort total (73, 37,2 %), d’un grand confort (48, 24,5 %) ou d’un confort raisonnable (58, 29,6 %). Le temps précédant le décès, l’usage de morphine et la perception des membres de la famille sur le confort du patient ont été similaires pour chacun des types de modification apportée à la VM.ConclusionLa majorité des patients meurent sans souffrance pendant le retrait du MS selon l’évaluation des membres de leur famille. La perception du confort du patient et l’usage de médicaments pendant les heures qui précèdent la mort ne sont pas associés au mode ou à la séquence du retrait du MS ou à la période de temps avant la mort.

The development and validation of a novel questionnaire to measure patient and family satisfaction with end-of-life care: the Canadian Health Care Evaluation Project (CANHELP) Questionnaire

The purpose of this study was to further validate a novel instrument to measure satisfaction with end-of-life care, called the Canadian Health Care Evaluation Project (CANHELP) questionnaire. Data were collected by a cross-sectional survey of patients who had advanced, life-limiting illnesses and their family caregivers, and who completed CANHELP, a global rating of satisfaction, and a quality of life questionnaire. We conducted factor analysis, assessed internal consistency using Cronbach’s alpha, and evaluated construct validity by describing the correlation amongst CANHELP, global rating of satisfaction and the quality of life questionnaire scores. There were 361 patient and 193 family questionnaires available for analysis. In the factor analysis, we identified six easily interpretable factors which explained 55.4% and 60.2% of the variance for the patient and caregiver questionnaire, respectively. For the patient version, the subscales derived from these factors were Relationship with Doctors, Illness Management, Communication, Decision-Making, Role of the Family, and Your Well-being. For the family questionnaire, the factors were Relationship with Doctors, Characteristics of Doctors and Nurses, Illness Management, Communication and Decision-Making, Your Involvement, and Your Well-being. Each subscale for each questionnaire had acceptable to excellent internal consistency (Cronbach’s alpha ranged from 0.69—0.94). We observed good correlations between the CANHELP overall satisfaction score and global rating of satisfaction (correlation coefficient 0.49 and 0.63 for patient and family, respectively) which was greater than the correlations between CANHELP and the quality of life instruments. We conclude that the CANHELP Questionnaire is a valid and internally consistent instrument to measure satisfaction with end-of-life care.