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

Intensive Care Unit, Vega Baja Hospital of Orihuela, Orihuela, Alicante, Spain. Department of Clinical Medicine, Miguel Hernandez University, San Juan de Alicante, Alicante, Spain. Intensive Care Unit, General University Santa Lucia Hospital of Cartagena, Cartagena, Murcia, Spain. Intensive Care Unit, University Hospital of San Juan de Alicante, San Juan de Alicante, Alicante, Spain. Intensive Care Unit, Lluis Alcanyis Hospital of Xativa, Xativa, Valencia, Spain. Intensive Care Unit, Marina Baixa Hospital of Villajoyosa, Villajoyosa, Alicante, Spain. Intensive Care Unit, General University Hospital of Alicante, Alicante, Alicante, Spain. Intensive Care Unit, La Plana Hospital of Villarreal, Villarreal, Castellon, Spain. Intensive Care Unit, Francesc de Borja Hospital of Gandia, Gandia, Valencia, Spain. Department of Clinical Medicine, Miguel Hernandez University, San Juan de Alicante, Alicante, Spain antonio.pb23@gmail.com.

BMJ open. 2019;9(12):e030139
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Abstract
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, Reduccion de la Mortalidad Plasma-Adsorcion (ROMPA), to demonstrate an absolute mortality reduction of 20% (alpha=0.05; 1-beta=0.8; n=190 (95x2)). 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.
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Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine