Adjuvant Lipoic acid Injection in Sepsis treatment in China (ALIS study): protocol for a randomised, single-blind, placebo-controlled trial.

INTRODUCTION: Sepsis is a life-threatening immune disorder resulting from an dysregulated host response to infection. Adjuvant therapy is a valuable complement to sepsis treatment. Lipoic acid has shown potential in attenuating sepsis-induced immune dysfunction and organ injury in vivo and in vitro studies. However, clinical evidence of lipoic acid injection in sepsis treatment is lacking. Hence, we devised a randomised controlled trial to evaluate the efficacy and safety of lipoic acid injection in improving the prognosis of sepsis or septic shock patients. METHODS AND ANALYSIS: A total of 352 sepsis patients are planned to be recruited from intensive care units (ICUs) at eight tertiary hospitals in China for this trial. Eligible participants will undergo randomisation in a 1:1 ratio, allocating them to either the control group or the experimental group. Both groups received routine care, with the experimental group also receiving lipoic acid injection and the control group receiving placebo. The primary efficacy endpoint is 28-day all-cause mortality. The secondary efficacy endpoints are as follows: ICU and hospital mortality, ICU and hospital stay, new acute kidney injury in ICU, demand and duration of life support, Sequential Organ Failure Assessment (SOFA)/Acute Physiology and Chronic Health Evaluation II (APACHE II) and changes from baseline (ΔSOFA/ΔApache II), arterial blood lactate (LAC) and changes from baseline (ΔLAC), blood procalcitonin, high-sensitivity C-reactive protein, interleukin-2 (IL-2), IL-4, IL-6, IL-10, tumour necrosis factor-α (TNF-α) and interferon-γ (IFN-γ) and changes from baseline on day 1 (D1), D3, D5 and D7. Clinical safety will be assessed through analysis of adverse events. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of Maoming People's Hospital (approval no. PJ2020MI-019-01). Informed consent will be obtained from the participants or representatives. The findings will be disseminated through academic conferences or journal publications. TRIAL REGISTRATION: ChiCTR2000039023.

Ventilator-associated pneumonia prevention in the Intensive care unit using Postpyloric tube feeding in China (VIP study): study protocol for a randomized controlled trial.

BACKGROUND: Ventilator-associated pneumonia is a challenge in critical care and is associated with high mortality and morbidity. Although some consensuses on preventing ventilator-associated pneumonia are reached, it is still somewhat controversial. Meta-analysis has shown that postpyloric tube feeding may reduce the incidences of ventilator-associated pneumonia, which still desires high-quality evidence. This trial aims to evaluate the efficacy and safety profiles of postpyloric tube feeding versus gastric tube feeding. METHODS/DESIGN: In this multicenter, open-label, randomized controlled trial, we will recruit 924 subjects expected to receive mechanical ventilation for no less than 48 h. Subjects on mechanical ventilation will be randomized (1:1) to receive postpyloric or gastric tube feeding and routine preventive measures simultaneously. The primary outcome is the proportion of patients with at least one ventilator-associated pneumonia episode. Adverse events and serious adverse events will be observed closely. DISCUSSION: The VIP study is a large-sample-sized, multicenter, open-label, randomized, parallel-group, controlled trial of postpyloric tube feeding in China and is well-designed based on previous studies. The results of this trial may help to provide evidence-based recommendations for the prevention of ventilator-associated pneumonia. TRIAL REGISTRATION: Chictr.org.cn ChiCTR2100051593 . Registered on 28 September 2021.

[Value of right ventricular ejection fraction in the preoperative risk evaluation for pulmonary resection].

BACKGROUND: To evaluate the preoperative right ventricular ejection fraction (RVEF) as a predictor of postoperative complications after lung resection. METHODS: RVEF was consecutively assessed in 254 patients before pulmonary resection by echocardiography. According to preoperative right ventricular function, the patients were divided into: group Ia (n=82, RVEF≥45%), group Ib (n=92,RVEF < 45%), group Ic (n=42, RVEF < 40%),and group Id (n=38, RVEF≤35%). Postoperative RVEF was detected again in 122 patients 3 weeks later after lung resection. RESULTS: Preoperative RVEF of patients with postoperative complications was significantly higher than that of patitents without postoperative complications (P < 0.001). Among group Ia, Ib, Ic, and Id, there were significant differences in postoperative morbidities (P < 0.005). Patients with a preoperative RVEF less than 40% had a higher incidence of complications than those with RVEF over 40% (P < 0.005). Of the 122 patients, postoperative RVEF was remarkably lower than preoperative RVEF (P < 0.01). CONCLUSIONS: The preoperative RVEF may be a predictor of postoperative complications for lung resection. RVEF higher than 40% is considered as a safe range for pneumonectomy.