Storage of red blood cells in a novel polyolefin blood container: a pilot in vitro study.

BACKGROUND AND OBJECTIVES: The present general plasticizer di-2-ethylhexyl-phthalate in polyvinylchloride (PVC) blood bags is only physically dispersed in PVC and will therefore leach into blood components. The objective of this study was to perform a first preliminary red blood cell (RBC) storage evaluation in a new blood bag manufactured of polyolefin without any inclusion of potentially migrating substances. STUDY DESIGN AND METHODS: This is a RBC storage study for 42 days. Blood collection was performed in a polyolefin-based PVC-free blood bag. RBCs were prepared within 8 h. Two different RBC additive solutions were used, either PAGGS-M or PAGGG-M. We weekly measured pH, K+ , glucose, lactate, haemolysis, red cell ATP and 2,3-DPG. RESULTS: RBC storage in PAGGS-M resulted in high haemolysis levels already after 21 days, exceeding the European maximum limit of 0·8%, and low ATP levels by the end of the storage period. With PAGGG-M, haemolysis exceeded 0·8% after 28 days of storage. For additional parameters, the results were comparable to those of previous studies in conventional blood bags. CONCLUSION: This is a first preliminary study of RBC storage in a new type of blood bags. PAGGG-M gave encouraging results except for its inability to prevent increased haemolysis. There will be room for further development of RBC additive solutions to address the haemolysis problems. Plasma should also be tested regarding the stability of coagulation and activation pathway variables. There may also be a potential for future use of the bag for preparation of pooled buffy-coat-derived platelets.

Status and solutions to medical device regulations for improving the healthcare landscape in Africa.

For different reasons most African countries have a poor public healthcare system compared to developed countries. Despite an increasing number of patients they often lack skilled health workers as well as basic medical equipment. This paper focuses on the development of an affordable and sustainable system for medical device regulations to provide safe, effective and quality healthcare products for Africa. Furthermore, it is determined whether Open Source Medical Devices are an effective alternative for medical device regulations to increase innovations in Africa.

Use of sedative and analgesic drugs in the first week of ICU stay. A pharmaco-epidemiological perspective.

AIM: To assess the current practice of pharmacological sedation and analgesia in patients admitted in Italian intensive care units. DESIGN: observational, prospective, cohort study, involving all patients admitted during a one-month period to participating Centers in 1994. All patients were followed-up for vital status until discharge and evaluated for pharmacological sedation and analgesia for the first week of ICU stay. SETTING: 128 Italian, adult, general, intensive care units, approximately representing 1/3 of all Italian Units. PATIENTS: 2932 patients were analyzed. They generated 22612 patient-days of intensive care unit stay, 11221 of which were evaluated. RESULTS: A total of 31 different sedative drugs were used in 1751 patients. On 64% of sedated days only one drug was utilized, whereas two or more drugs were administered in the remaining days. Propofol was the most widely prescribed drug, followed by fentanyl and diazepam, while morphine accounted for 14.8% of sedated days. The analysis of the pattern of sedation over time revealed a trend to linearly reduce the use of this practice. CONCLUSIONS: Our results depict a relatively low prevalence of sedation in Italy, with the use of large number of different agents. We also observed a larger than expected use of some drugs, like propofol and fentanyl, that could be due to the unavailability of new sedative and analgesic drugs in Italy on 1994. In conclusion, Italian intensivists seem to be very conservative about the practice of pharmacological sedation in critically ill patients.

Antithrombin replacement in patients with sepsis and septic shock.

Sepsis is a frequent complication of critically ill patients and its incidence is increasing. Currently, septic shock is the most common cause of death in non-coronary intensive care units. Over the last 10 to 15 years, new antibiotics and increasingly sophisticated critical care have had little impact on the mortality rate of septic shock. The Italian SEPSIS Study, carried out in 99 intensive care units in 1994, reported mortality rates of 52% and 82% for severe sepsis and septic shock respectively. New therapeutic approaches aimed at neutralizing microbial toxins and modulating host mediators have shown some efficacy in large clinical trials and/or in animal models, but to date, no therapy of sepsis aimed at reversing the effects of bacterial toxins or of harmful endogenous mediators of inflammation has gained widespread clinical acceptance. Because of the strong association of severe sepsis with a state of activation of blood coagulation and of the potential role of capillary thrombosis in the development of the multiple organ dysfunction syndrome, anticoagulant agents have been tested in the setting of septic shock. However, neither administration of heparin nor of active site-blocked factor Xa or of anti-tissue factor antibodies have proven effective in preventing deaths due to septic shock in animal models. In contrast, infusion of antithrombin, protein C, or tissue factor pathway inhibitor all resulted in a significant survival advantage in animals receiving lethal doses of E. Coli. Antithrombin concentrates have been used in a significant number of critically ill patients. A double-blind, placebo controlled study carried out in 3 italian intensive care units has recently shown that the administration of antithrombin aimed to normalize plasma antithrombin activity had a net beneficial effect on 30-day survival of patients requiring respiratory and/or hemodynamic support because of severe sepsis and/or post-surgery complications.

Predicting outcome in the intensive care unit using scoring systems: is new better? A comparison of SAPS and SAPS II in a cohort of 1,393 patients. GiViTi Investigators (Gruppo Italiano per la Valutazione degli interventi in Terapia Intensiva). Simplified Acute Physiology Score.

OBJECTIVES: This study sought to compare the performance of the old and new versions of the Simplified Acute Physiology Score, SAPS and SAPS II, in classifying patients according to the risk of hospital mortality. METHODS: To compare the performance of the two systems, measures of association between the scores and observed mortality were adopted, together with discrimination (area under the Receiver Operating Characteristics curve) and calibration (goodness-of-fit statistics) estimates. Subjects were 1,393 eligible patients recruited during 1 month in 1994. The outcome measure was vital status at hospital discharge. RESULTS: SAPS II was associated more strongly with hospital mortality than the earlier version. SAPS II also had better discrimination ability than SAPS (area under Receiver Operating Characteristics curve 0.80 versus 0.74) and predicted an overall number of deaths (416.5) closer to the observed figure (475) than SAPS (267.7). Conversely, neither SAPS nor SAPS II fitted our data. Both P values derived from goodness-of-fit statistics were lower than 0.05. CONCLUSIONS: SAPS II offers a real improvement compared with SAPS in its ability to explain hospital mortality, but its standard parameters do not fit our data from Italy. The role and impact of potential determinants of this lack of fit, such as random errors and confounders related to casemix and/or quality of care should be clarified before this scoring system be used outside formal research projects. Special caution is suggested when SAPS II is adopted to predict mortality to compare intensive care unit performance across different countries and systems of care.

Antithrombin III (ATIII) replacement therapy in patients with sepsis and/or postsurgical complications: a controlled double-blind, randomized, multicenter study.

BACKGROUND: ATIII is decreased in sepsis and/or shock and its baseline value correlates with mortality. The efficacy of ATIII therapy on mortality was assessed in a selected group of patients admitted to the intensive care unit (ICU) in a double-blind, randomized, multicenter study. METHODS: 120 patients admitted to the ICU with an ATIII concentration < 70% were randomized to receive ATIII (total dose 24000 units) or placebo treatment for 5 days; 56 patients had septic shock. RESULTS: ATIII concentrations in the treated group remained constant throughout the treatment period (range 97-102%). The Kaplan-Meier analysis showed no difference in overall survival between the two groups: 50 and 46% for ATIII and placebo, respectively. Septic shock and hemodynamic support were unbalanced in the two groups at admission. Therefore the Cox analysis was carried out after adjusting for these two variables. Treatment with ATIII decreases the risk of death with an odds ratio (OR) of 0.56. Of the covariates analyzed, septic shock and the baseline multiple organ failure score were negatively associated with survival and plasma activity level was positively associated with survival with an OR of 0.97 for each 1% increase in the ATIII plasma concentration at baseline. CONCLUSIONS: The results of ATIII treatment in this population of patients suggests that replacement therapy reduces mortality in the subgroup of septic shock patients only.

["ARCHIDIA": a system for patients' data collection and computerized filing. Part I. Methodology]. / Sistema di raccolta dati paziente e archiviazione computerizzata "ARCHIDIA". Parte I--Metodologia.

This report describes a computer based program of patient clinical data collection: the ARCHIDIA system. The project relies on descriptive analysis of clinical events according to well defined methodological criteria. This allows the formulation of a concise diagnosis which is, at the same time, exhaustive of all essential information. Two are the basis principles of this methodology: To define, as accurately as possible, the logical steps necessary to elaborate the diagnosis, that is construed by a sequence of codes. To define all the conditions that must be followed so to use any code in a controlled and independent way. These criteria were derived from literature. The major claim of the system is likely to be the introduction of a "common language" between different ICUs. Uniformed diagnostic and clinical criteria are the main source of large data collection for descriptive, analytic and prospective studies. After a one year pilot study performed by 4 ICUs, ARCHIDIA was used, in 1991, by 20 centers from the area of Milan, Pavia, Como, Varese (70% of total) and 4148 patient data were collected. A descriptive analysis will be reported in the following paper.

["ARCHIDIA": a system for patients' data collection and computerized filing. Part II. General description of a caseload]. / Sistema di raccolta dati paziente e archiviazione computerizzata "ARCHIDIA". Parte II--Descrizione generale della casistica.

OBJECTIVE: To describe a population of patients admitted in ICU in an homogeneous urban area by means of a computed system. EXPERIMENTAL DESIGN: Observational study. SETTING: 20 general intensive care units of general and university hospitals. PATIENTS: Patients admitted in ICU from 1-1-1991 to 31-12-1991. 3 centers collected patients only for 6 months, starting on 1-6-1991. MEASUREMENTS: For each patient demographic data, hospitalization data, outcome, diagnosis and diagnostic procedures used during hospitalization according to defined criteria previously described, were collected. Data have been collected on PC using dedicated software. RESULTS: All centers concluded data collection, none abandoned the study. General characteristics of 4148 valuable patients were reported. Age was 52.9 years, SAPS 12.4 and mortality 21.7%. The patients spent 8.7 days in ICU and, when transferred to a general ward, the following hospitalization was 21.5 days. CONCLUSIONS: Data collection demonstrated the project feasibility. It realizes a continue up to date system inside each unit and allows the use of a "common language" and homogeneous methodology between centers.

Reliability of the vestibulo-ocular reflex as an index of the effects of hypnotic drugs on the central nervous system.

The vestibulo-ocular reflex was tested after the administration of step doses of thiopentone or propanidid in 171 unpremedicated patients. The dose of thiopentone (3 mg kg-1) required to induce loss of nystagmus also abolished the response to verbal command. The dose required to inhibit the reflex in 95% of patients was 7.22 mg kg-1 and prevented adrenergic responses to nociceptive stimulation. The dose of propanidid required to induce loss of nystagmus was greater than that necessary to abolish response to verbal command. The reflex inhibition rate increased proportionally to the dose up to 8 mg kg-1; larger doses exerted a facilitatory effect and reduced the reflex inhibition rate. The vestibulo-ocular reflex is a reliable and sensitive means of demonstrating the different effects exerted by step doses of hypnotic drugs.

The treatment of hydrogen sulfide intoxication: oxygen versus nitrites.

A case of severe H2S intoxication, treated with oxygen, respiratory support and thiopental cerebral protection, is presented. The usual antidotal treatments using nitrites or oxygen are discussed, examining the risks of nitrite use and the efficacy of oxygen. The successful outcome of the case presented suggests that H2S poisoning be treated with oxygen and vigorous organ supportive care.