The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial.

INTRODUCTION: Severe sepsis is associated with a high mortality rate despite implementation of guideline recommendations. Adjunctive treatment may be efficient and require further investigation. In light of the crucial role of immunologic derangement in severe sepsis, thymosin alpha 1 (Tα1) is considered as a promising beneficial immunomodulatory drug. The trial is to evaluate whether Tα1 improves 28-day all-cause mortality rates and immunofunction in patients with severe sepsis. METHODS: We performed a multicenter randomized controlled trial in six tertiary, teaching hospitals in China between May 12, 2008 and Dec 22, 2010. Eligible patients admitted in ICU with severe sepsis were randomly allocated by a central randomization center to the control group or Tα1 group (1:1 ratio). The primary outcome was death from any cause and was assessed 28 days after enrollment. Secondary outcomes included dynamic changes of Sequential Organ Failure Assessment (SOFA) and monocyte human leukocyte antigen-DR (mHLA-DR) on day 0, 3, 7 in both groups. All analyses were done on an intention-to-treat basis. RESULTS: A total of 361 patients were allocated to either the control group (n = 180) or Tα1 (n = 181) group. The mortalities from any cause within 28 days in the Tα1 group and control group were 26.0% and 35.0% respectively with a marginal P value (nonstratified analysis, P = 0.062; log rank, P = 0.049); the relative risk of death in the Tα1 group as compared to the control group was 0.74 (95% CI 0.54 to 1.02). Greater improvement of mHLA-DR was observed in the Tα1 group on day 3 (mean difference in mHLA-DR changes between the two groups was 3.9%, 95% CI 0.2 to 7.6%, P = 0.037) and day 7 (mean difference in mHLA-DR changes between the two groups was 5.8%, 95% CI 1.0 to 10.5%, P = 0.017) than in the control group. No serious drug-related adverse event was recorded. CONCLUSIONS: The use of Tα1 therapy in combination with conventional medical therapies may be effective in improving clinical outcomes in a targeted population of severe sepsis. TRIAL REGISTRATION: ClinicalTrials.gov NCT00711620.

Tracheal stent placement provides opportunity for subsequent anti-cancer therapy for cancer patients with malignant respiratory complications.

BACKGROUND: Critically ill patients with severe acute dyspnea due to malignant tracheal stenosis or tracheoesophageal fistula often need advanced respiratory support. Tracheal stenting is an important palliative treatment of such patients. This study retrospectively analyzes the efficacy and outcomes of airway stenting in patients with tracheal stenosis or tracheoesophageal fistula. METHODS: Patients underwent stenting from 2005 to 2018 in a single center were reviewed. Ninety-seven patients with malignant tracheal stenosis and/or tracheoesophageal fistula who underwent stenting were analyzed, all these patients had poor respiratory status. RESULTS: The median survival time of patients after stent placement was 119 days. Forty-five patients were treated with anti-tumor therapy after placing the stent. Discharged intensive care unit (ICU) within 3 days and postoperative antitumor treatment were independent predictors for the survival time after tracheal stenting (P<0.05). CONCLUSIONS: Tracheal stent implantation played an important role for additional anti-cancer treatment.

[Influence of trauma-hemorrhagic shock on endotoxin, tumor necrosis factor-alpha and interleukin-6 levels in mesenteric lymph and blood of rats].

OBJECTIVE: To investigate the influence of trauma-hemorrhagic shock on endotoxin (ET), tumor necrosis factor-alpha (TNF-alpha) and interleukin-6 (IL-6) levels in mesenteric lymph and blood of rats. METHODS: Mesenteric lymph from trauma-hemorrhagic shock rats were collected, levels of ET, TNF-alpha and IL-6 in mesenteric lymph were compared with those from blood samples. RESULTS: Levels of ET, TNF-alpha and IL-6 in mesenteric lymph were elevated during shock period (all P<0.05), and they were decreased to normal range after resuscitation, with an exception of high IL-6 level up to 2 hours following resuscitation. CONCLUSION: The bacterial translocation could occur during shock period via lymphatic pathway, thereby leading to the increase in TNF-alpha and IL-6 levels, as well as systemic inflammatory response syndrome.

Current situation and associated factors of withdrawing or withholding life support to patients in an intensive care unit of cancer center in China.

OBJECTIVES: To investigate the current situation and analyze the associated factors of withdrawing or withholding life support in the intensive care unit (ICU) of our cancer center. METHODS: Three hundred and twenty-two cancer patients in critical status were admitted to our ICU in 2010 and 2011. They were included in the study and were classified into two groups: withdrawing or withholding life support (WWLS), and full life support (FLS). Demographic information and clinical data were collected and compared between the two groups. Factors associated with withdrawing or withholding life support were analyzed with univariate and multivariate logistic regression analysis. RESULTS: Eighty-two of the 322 cases (25.5% of all) made the decisions to withdraw or withhold life support. Emergency or critical condition at hospital admission, higher scores of Acute Physiology and Chronic Health Evaluation II (APACHE II) in 12 hours after ICU admission, financial difficulties and humanistic care requirements are important factors associated with withdrawing or withholding life support. CONCLUSIONS: Withdrawing or withholding life support is not uncommon in critically ill cancer patients in China. Characteristics and associated factors of the decision-making are related to the current medical system, medical resources and traditional culture of the country.

Serum levels of procalcitonin as a biomarker for differentiating between sepsis and systemic inflammatory response syndrome in the neurological intensive care unit.

We explored the value of procalcitonin (PCT) to differentiate sepsis from systemic inflammatory response syndrome (SIRS), and determine sepsis severity in the neurological intensive care unit (NICU). Blood samples were measured for C-reactive protein (CRP) and PCT levels upon NICU admission, on the day of diagnosis of SIRS or sepsis, and at 3 and 7 days after diagnosis. We found that there were significant differences in serum levels of CRP and PCT as well as Glasgow Coma Scale (GCS) score upon admission between the SIRS and sepsis groups (p<0.05). CRP and white blood cell levels were not significantly different when attempting to differentiate sepsis severity (p>0.05). Multiple comparisons showed that significant differences in serum PCT levels were observed between sepsis and severe sepsis groups, as well as sepsis and septic shock groups (p<0.05). We obtained the highest sensitivity and specificity for SIRS and sepsis with cut-off values of 2 ng/mL for PCT, 44 mg/dL for CRP, and 4 for the GCS. There were no differences in CRP and PCT levels between cerebrovascular disease and non-cerebrovascular disease groups (p>0.05). No differences were found between viral and bacterial meningitis groups (p>0.05). PCT levels are valuable in discriminating sepsis from SIRS and determining sepsis severity in critically ill patients with neurological disease.

N-terminal prohormone B-type natriuretic peptide and weaning outcome in postoperative patients with pulmonary complications.

OBJECTIVE: To evaluate the relationship between plasma N-terminal prohormone B-type natriuretic peptide (NT-proBNP) and weaning outcomes, and the ability of NT-proBNP level to predict weaning success, in cancer patients with pulmonary complications undergoing noncardiac major surgeries. METHODS: Patients who were mechanically ventilated following postoperative respiratory failure were enrolled. NT-proBNP levels at the end of a 2-h spontaneous breathing trial were measured. Weaning was considered a success in patients who completed the trial and maintained spontaneous breathing following extubation for >48 h. RESULTS: Out of 29 patients, 22 patients weaned successfully but weaning failed in 7 patients. Plasma NT-proBNP was significantly higher in the weaning failure group than in the weaning success group. For predicting weaning success, the optimal NT-proBNP threshold value at the end of the spontaneous breathing trial was <448 ng/l (receiver operating characteristic analysis; sensitivity 68.18%, specificity 85.71%, positive predictive value 93.7% and negative predictive value 46.2%). CONCLUSION: Measuring NT-proBNP at the end of a spontaneous breathing trial may assist in predicting weaning success, as a noninvasive, quantitative and repeatable indicator of cardiac stress in patients with postsurgical respiratory failure.