The effect of older blood on mortality, need for ICU care, and the length of ICU stay after major trauma.

The purpose of this study was to determine if the quantity and age of blood is an independent risk factor for in-hospital mortality, need for intensive care unit (ICU) care, and an increased length of stay in the ICU. This was a retrospective cohort study performed at a level I trauma center between 2001 and 2003. Consecutive trauma patients who received at least 1 unit of packed red blood cells (PRBCs) were included. The number of units of PRBCs transfused and the ages of each unit of PRBCs were recorded. Other variables including the patient's age, sex, Trauma-Related Injury Severity Score (TRISS), and whether the blood was leukopoor were collected. End points included in-hospital mortality, need for ICU care, and the length of stay in the ICU (in days). Multivariable logistic and Poisson regression analyses were performed to model the independent effect of the dose of aged blood (defined as the product of the average age of all units received and the total number of units received) with respect to each end point while controlling for age, TRISS, the total number of units administered, and the proportion of blood that was leukopoor. During the study period, 275 patients were studied. Patients who received older blood had a significantly longer ICU stay (RR 1.15, 95% CI: 1.11-1.20), possibly reflecting a higher level of organ dysfunction. Patients who received older blood, however, did not have a significantly higher in-hospital mortality rate (OR 1.21, 95% CI: 0.87-1.69) or a significantly higher need for ICU care (OR 1.20, 95% CI: 0.87-1.64). The quantity of aged blood is an independent risk factor for length of ICU care. This may be a proxy indicator for multiple organ failure. Further research is required to define which patients may benefit from newer blood.

Results of a multicenter, randomized, open-label efficacy and safety study of two doses of tigecycline for complicated skin and skin-structure infections in hospitalized patients.

BACKGROUND: Tigecycline is a broad-spectrum glycylcycline antibiotic being investigated for the treatment of serious infections in hospitalized patients. Tigecycline has been shown to be efficacious against serious infections in animals, and preliminary studies in healthy adults have shown that tigecycline has an acceptable tolerability profile. OBJECTIVE: This study compared the clinical and microbiological efficacy, pharmacokinetic properties, and tolerability of 2 doses of tigecycline in hospitalized patients with a complicated skin and skin-structure infection (cSSSI). METHODS: This Phase II, randomized, open-label study was conducted between September 1999 and March 2001 at 14 investigative centers across the United States. Patients were randomized to receive tigecycline 25 or 50 mg IV q12h for 7 to 14 days. The primary efficacy end point was the clinically observed cure rate among clinically evaluable (CE) patients at the test-of-cure visit. Secondary end points were the clinical cure rate at the end of treatment and bacteriologic response in microbiologically evaluable (ME) patients. Also, in vitro tests of susceptibility to tigecycline were performed for selected pathogens known to cause skin infections, including methicillin-resistant and methicillin-susceptible Streptococcus pyogenes, Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, and Enterococcus faecium. Tolerability assessments also were conducted. RESULTS: A total of 160 patients received > or =1 dose of tigecycline; 109 patients were CE, and 91 were ME. The majority of patients (74%) were men, and the mean (SD) age was 49.0 (14.8) years. At the test-of-cure visit, the clinical cure rate in the 25-mg group was 67% (95% CI, 53.3%-79.3%) and in the 50-mg group was 74% (95% CI, 60.3%-85.0%). In the 25-mg group, 56% of the patients had eradication (95% CI, 40.0%-70.4%) of the pathogens compared with 69% (95% CI, 54.2%-82.3%) in the 50-mg group. Values for the minimum concentration of tigecycline that is inhibitory for 90% of all isolates ranged from 0.06 to 0.50 microg/mL for the selected pathogens. Both tigecycline doses were generally well tolerated. Nausea and vomiting were the most common adverse events. CONCLUSIONS: In this study, tigecycline appeared efficacious and showed a favorable pharmacokinetic profile and an acceptable safety profile in the treatment of hospitalized patients with cSSSI. In patients who received 50-mg doses of tigecycline q12h, the clinical cure rates and microbial eradication rates were 74% and 70%, respectively, and were 67% and 56% in patients who received 25-mg doses.

A validation trial of subdermal injection compared with intraparenchymal injection for sentinel lymph node biopsy in breast cancer.

Sentinel lymph node (SLN) biopsy is increasingly being used as an accurate and less morbid surrogate for axillary dissection. However, a standardized technique in the biopsy of SLNs is not used. Some authors propose subdermal injection to be as accurate as peritumoral intraparenchymal injection (IPI). Our objective is to determine whether the SLNs identified by subdermal injection truly represent SLNs and match those found with IPI. Specific end points of the study were 1) successful localization of the SLN by the IPI of isosulfan blue or the radiocolloid intradermal injection, 2) successful uptake of radiocolloid and isosulfan blue on individual SLN, and 3) determination of the frequency with which the radiocolloid injection detected the "gold standard" blue SLN. SLNs were found in 71 of 73 cases (success rate = 97%). Blue SLNs were identified in 64 patients (88%). SLNs in 61 patients (84%) were radioactive. A total of 112 SLNs were identified in 71 patients (1.6 nodes/patient). Seventy-six of 87 SLNs found with IPI were also radioactive (concordance of 87%). All SLNs harboring metastatic cancer (16 patients) were found by both techniques, being both blue and radioactive. Our results support the concept of shared lymphatic pathways in the breast with a high degree of communication between the subdermal lymphatics and the intraparenchymal lymphatics. The success in identification of the SLN is made simpler and improved by the addition of subdermal radiocolloid injection.

Immediate preoperative injection of 99m-Tc sulfur colloid is effective in the detection of breast sentinel lymph nodes.

Sentinel lymph node (SLN) biopsy is an accurate technique to determine the metastatic status of lymph nodes. Radionuclide guidance makes the procedure easier and improves the success rate. Coordinating the operating room and nuclear medicine schedules causes delays when same-day radionuclide injection is used. We hypothesized that injection of 99m-Tc sulfur colloid immediately preoperatively is effective in SLN detection. We analyzed a prospective database of 70 patients treated at Harbor-UCLA Medical Center. The first 39 patients underwent completion axillary dissection (Group A) and subdermal injection of sulfur colloid immediately before surgery. A second group of 31 patients (Group B) had intraparenchymal injection immediately before surgery. We used isosulfan blue in all cases. SLNs were identified in 97 per cent of cases. SLNs were radioactive in 94 per cent and blue in 90 per cent. In Group A the accuracy and the positive and negative predictive values of SLN biopsy were 100 per cent. SLN counts per second ranged from 22 to 1700. The mean count per second was 290 +/- 281 (mean +/- standard deviation). Subdermal and intraparenchymal injections were equally successful (93% vs 92%). In conclusion injection of radiocolloid and isosulfan blue immediately preoperatively is highly successful and accurate in the detection of SLNs in breast cancer. It avoids operating room schedule delays.