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.

Construction and internal validation of a new mortality risk score for patients admitted to the intensive care unit.

BACKGROUND: The existing models to predict mortality in intensive care units (ICU) present difficulties in clinical practice. OBJECTIVES: The aim of this study was to develop and internally validate a points system to predict mortality in the ICU, which can be applied instantly and with high discriminating power. METHODS: This cohort study comprised all patients admitted to the ICU in a Spanish region between January 2013 and April 2014, followed from admission to death or discharge (N=1113). Primary variable: ICU mortality. Secondary variables at admission: gender, Fried criteria for frailty, function scale, medical admission, cardiac arrest, cardiology admission, sepsis, mechanical ventilation, inotropic support, age, frailty index and clinical frailty scale. The sample was divided randomly into two groups (80% and 20%): construction (n=844) and internal validation (n=269). Construction: A logistic regression model was implemented and adapted to the points system. VALIDATION: the area under the ROC curve (AUC) of the model was calculated and the risk quintiles were created to determine whether differences existed between observed and expected deaths. RESULTS: The points system included: function scale, medical admission, cardiology admission, sepsis, mechanical ventilation and inotropic support. The validation showed: (i) AUC=0.95 (95% CI: 0.91-0.99, p<.001); (ii) No differences between observed and expected deaths (p=.799). CONCLUSIONS: A predictive model of mortality in the ICU has been constructed and internally validated. This model improves on the previous models through its simplicity, its discriminating power and free use. External validation studies are needed in other geographical areas.

Rotura hepática espontánea en el síndrome HELLP / Spontaneous liver rupture in HELLP syndrome

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