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

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, Reducción de la Mortalidad Plasma-Adsorción (ROMPA), to demonstrate an absolute mortality reduction of 20% (α=0.05; 1-β=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 participati

SUBMITTER: Gimenez-Esparza C 

PROVIDER: S-EPMC6924739 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature