The premature closure of ROMPA clinical trial: mortality reduction in septic shock by plasma adsorption.

OBJECTIVES: Coupled Plasma Filtration and Adsorption (CPFA) use in septic shock remains controversial. The objective is to clarify whether the application of high doses of CPFA in addition to the current clinical practice could reduce hospital mortality in septic shock patients in Intensive Care Units at 28 days and at 90 days follow-up. DESIGN: We designed a prospective randomised clinical trial, Reducción de la Mortalidad Plasma-Adsorción (ROMPA), to demonstrate an absolute mortality reduction of 20% (α=0.05; 1-ß=0.8; n=190 (95×2)). SETTING: Being aware of the pitfalls associated with previous medical device trials, we developed a training programme to improve CPFA use (especially clotting problems). The protocol was approved by the ethics committees of all participating centres. Circumstances beyond our control produced a change in recruitment conditions unacceptable to ROMPA researchers and the trial was discontinued. PARTICIPANTS: By closure, five centres from an initial 10 fulfilled the necessary trial criteria, with 49 patients included, 30 in the control group (CG) and 19 in the intervention group (IG). INTERVENTION: CPFA. MAIN OUTCOME MEASURES: Hospital mortality at 28 days and 90 days follow-up. RESULTS: After 28 days, 14 patients died (46.7%) from the CG and 11 (57.9%) from the IG, not reaching statistical significance (p=0.444). At 90 days, 19 patients had died (63.3%) from the CG and 11 patients (57.9%) from the IG, (p=0.878). The adjustment by propensity score or the use of the Kaplan-Meier technique failed to achieve statistical difference, neither by Intention to Treat nor by the Actual Intervention Received. CONCLUSION: We herewith present the results gained from the prematurely closed trial. The results are inconclusive due to low statistical power but we consider that this data is of interest for the scientific community and potentially necessary for any ensuing debate. REGISTER: NCT02357433 in clinicaltrials.gov.

Mortality Reduction in Septic Shock by Plasma Adsorption (ROMPA): a protocol for a randomised clinical trial.

INTRODUCTION: There is a lack of evidence in the efficacy of the coupled plasma filtration adsorption (CPFA) to reduce the mortality rate in septic shock. To fill this gap, we have designed the ROMPA study (Mortality Reduction in Septic Shock by Plasma Adsorption) to confirm whether treatment with an adequate dose of treated plasma by CPFA could confer a clinical benefit. METHODS AND ANALYSIS: Our study is a multicentric randomised clinical trial with a 28-day and 90-day follow-up and allocation ratio 1:1. Its aim is to clarify whether the application of high doses of CPFA (treated plasma ≥0.20 L/kg/day) in the first 3 days after randomisation, in addition to the current clinical practice, is able to reduce hospital mortality in patients with septic shock in intensive care units (ICUs) at 28 and 90 days after initiation of the therapy. The study will be performed in 10 ICUs in the Southeast of Spain which follow the same protocol in this disease (based on the Surviving Sepsis Campaign). Our trial is designed to be able to demonstrate an absolute mortality reduction of 20% (α=0.05; 1-ß=0.8; n=190(95×2)). The severity of the process, ensuring the recruitment of patients with a high probability of death (50% in the control group), will be achieved through an adequate stratification by using both severity scores and classical definitions of severe sepsis/septic shock and dynamic parameters. Our centres are fully aware of the many pitfalls associated with previous medical device trials. Trying to reduce these problems, we have developed a training programme to improve the CPFA use (especially clotting problems). ETHICS AND DISSEMINATION: The protocol was approved by the Ethics Committees of all the participant centres. The findings of the trial will be disseminated through peer-reviewed journals, as well as national and international conference presentations. TRIAL REGISTRATION NUMBER: NCT02357433; Pre-results.

Gastric versus transpyloric feeding in severe traumatic brain injury: a prospective, randomized trial.

PURPOSE: To evaluate the efficacy of transpyloric feeding (TPF) compared with gastric feeding (GF) with regard to the incidence of ventilator-associated pneumonia in severe traumatic brain injury patients (TBI). DESIGN AND SETTING: Prospective, open-label, randomized study in an intensive care unit of a university hospital. PATIENTS: One hundred and four CHI adult patients admitted for TBI between April 2007 and December 2008. Patients were included within the first 24 h after ICU admission and were followed until discharge or 30 days after admission. INTERVENTION: Patients were randomized to TPF or GF groups. They received the same diet, with 25 kcal kg(-1) day(-1) of calculated energy requirements and a nitrogen intake of 0.2 g N kg(-1) day(-1). Primary outcome was the incidence of early and ventilatory-associated pneumonia. Secondary outcomes were enteral nutrition-related gastrointestinal complications (GIC), days on mechanical ventilation, length of ICU stay and hospital stay, and sequential organ failure assessment score (SOFA). RESULTS: The TPF group had a lower incidence of pneumonia, OR 0.3 (95% CI 0.1-0.7, P = 0.01). There were no significant differences in other nosocomial infections. The TPF group received higher amounts of diet compared to the GF group (92 vs. 84%, P < 0.01) and had lesser incidence of increased gastric residuals, OR 0.2 (95% CI 0.04-0.6, P = 0.003). CONCLUSIONS: Enteral nutrition delivered through the transpyloric route reduces the incidence of overall and late pneumonia and improves nutritional efficacy in severe TBI patients.

[Use of non-invasive ventilation in acute respiratory failure. Multicenter study in intensive care units]. / Utilización de la ventilación no invasiva en la insuficiencia respiratoria aguda. Estudio multicéntrico en unidades de cuidados intensivos.

OBJECTIVES: Study the use of non-invasive ventilation (NIV) in patients with acute respiratory failure in intensive care units (ICUs) in Spain. METHODS: A questionnaire was sent to 254 ICUs, after which, they were invited to participate in a multicenter, retrospective study, providing detailed information on ventilated patients. RESULTS: Answers were received from 123 hospitals. Of these, 119 used NIV, although its use varied greatly. NIV is the treatment of choice in 89% of the units for chronic obstructive pulmonary disease (COPD), in 79% for acute pulmonary edema (APE), in 53% for postextubation failure, in 53% for pneumonia 53%, and in 17% for acute respiratory distress syndrome (ARDS). It was used occasionally in COPD in 11% of the units, and in 21% of the units for APE. Eighteen hospitals provided additional information on 432 ventilated patients, 232 (54%) of whom received NIV as first line therapy. Presence of pneumonia or acute respiratory distress syndrome (ARDS) was an independent predictive factor of NIV failure (ORa=5.71; CI 95%, 1.83-17.8; p=0.003). Admission in a unit with experience in NIV in >50 patients/year (ORa=0.22; CI 95%, 0.07-0.63; p=0.005) and a higher PaO2/FiO2 ratio after one hour of ventilation (ORa=0.98 per point; CI 95%, 0.97-0.99; p<0.001) were protector factors. CONCLUSIONS: In Spain, NIV is widely used but it may continue to be underused in COPD and APE. The diagnosis of pneumonia or ARDS was an independent predictive risk factor. Admission in an ICU with NIV in more than 50 patients/year also have higher PaO2/FiO2 ratio after one hour of ventilation were predictive factors of success.

Pancitopenia probablemente inducida por metamizol / Pancytopenia probably induced by metamizol

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