[Efficacy and safety of early physical therapy for acute gastrointestinal injury during mechanical ventilation in patients with sepsis: a randomized controlled pilot trial].

OBJECTIVE: To investigate the therapeutic effect and safety of early physical therapy for acute gastrointestinal injury (AGI) in septic patients receiving mechanical ventilation. METHODS: A randomized controlled trial was conducted in the ICU of a tertiary teaching hospital from May, 2017 to March, 2018. The patients diagnosed with sepsis complicated by AGI during mechanical ventilation were recruited and block-randomized into intervention group and control group. Both groups received standard therapy of sepsis, and the patients in the intervention group also received physical therapy as soon as they were hemodynamically stable. The outcome measures included the recovery of AGI, ICU mortality, duration and outcomes of mechanical ventilation and the length of ICU stay. RESULTS: A total of 60 patients were initially included, and 34 of them completed the study, including 16 in the intervention group and 18 in the control group. After physical rehabilitation, the number of patients with a cure of AGI did not significantly differ between the two group (P > 0.05). Nonetheless, the reduction of AGI scores after the treatments differed significantly between the intervention group and the control group (-1.9±2.1 vs 0.9± 1.6, P < 0.05). No significant differences were found between the two groups in ICU mortality, duration and outcomes of mechanical ventilation, or the length of ICU stay (P > 0.05). In the intervention group, the incidence of exercise-related adverse events was 3.33%, and severe organ injury or death occurred in none of patients. CONCLUSIONS: Early rehabilitation therapy does not reduce the incidence of AGI but can lower AGI scores and alleviate gastrointestinal symptoms in patients with sepsis during mechanical ventilation. The results still await further verification by welldesigned multicenter clinical trials with large sample sizes.

Metoclopramide or domperidone improves post-pyloric placement of spiral nasojejunal tubes in critically ill patients: a prospective, multicenter, open-label, randomized, controlled clinical trial.

INTRODUCTION: The use of prokinetic agents on post-pyloric placement of spiral nasojejunal tubes is controversial. The aim of the present study was to examine if metoclopramide or domperidone can increase the success rate of post-pyloric placement of spiral nasojejunal tubes. METHODS: A multicenter, open-label, randomized, controlled trial was conducted in seven hospitals in China between April 2012 and February 2014. Patients admitted to the intensive care unit and requiring enteral nutrition for more than three days were randomly assigned to the metoclopramide, domperidone or control groups (1:1:1 ratio). The primary outcome was defined as the success rate of post-pyloric placement of spiral nasojejunal tubes, assessed 24 hours after initial placement. Secondary outcomes included success rate of post-D1, post-D2, post-D3 and proximal jejunum placement and tube migration distance. Safety of the study drugs and the tubes during the entire study period were recorded. RESULTS: In total, 307 patients were allocated to the metoclopramide (n = 103), domperidone (n = 100) or control group (n = 104). The success rate of post-pyloric placement after 24 hours in the metoclopramide, domperidone and control groups was 55.0%, 51.5% and 27.3%, respectively (P = 0.0001). Logistic regression analysis identified the use of prokinetic agents, Acute Physiology and Chronic Health Evaluation (APACHE) II score <20, Sequential Organ Failure Assessment (SOFA) score <12 and without vasopressor as independent factors influencing the success rate of post-pyloric placement. No serious drug-related adverse reaction was observed. CONCLUSIONS: Prokinetic agents, such as metoclopramide or domperidone, are effective at improving the success rate of post-pyloric placement of spiral nasojejunal tubes in critically ill patients. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-TRC-12001956 . Registered 21 February 2012.