Trial reportBMJ open2019
The premature closure of ROMPA clinical trial: mortality reduction in septic shock by plasma adsorption.
Trial report in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02357433 (Reduccion de la Mortalidad Mediante Plasma-Adsorción en Shock séptico), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Reduccion de la Mortalidad Mediante Plasma-Adsorción en Shock séptico (ROMPA)
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 32 citations in OpenAlex.
- Coupled plasma filtration adsorption for the treatment of sepsis or septic shock: a systematic review and meta-analysis.BMC infectious diseases · 2022Pooled it
- [Extracorporeal immunomodulation in sepsis : Role, limits, and perspectives of adjuvant blood purification therapies].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2026Review
- Timing of hemoadsorption in sepsis: redefining early through mediator-guided therapy.Journal of intensive care · 2026Review
- The role of hemoadsorption in septic shock: toward a personalized approach.Critical care (London, England) · 2026Review
- Knowledge gaps in extracorporeal blood purification: what would be required for its successful application in septic shock?Intensive care medicine experimental · 2025Review
- Hemoadsorption in septic shock - CON.Intensive care medicine · 2025Article
- Macrophage activation syndrome in Sepsis: from pathogenesis to clinical management.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2024Review
- [Extracorporeal procedures in sepsis].Die Anaesthesiologie · 2024Review
- Septic Hyperinflammation-Is There a Role for Extracorporeal Blood Purification Techniques?International journal of molecular sciences · 2024Review
- Endotoxemia in Acute Heart Failure and Cardiogenic Shock: Evidence, Mechanisms and Therapeutic Options.Journal of clinical medicine · 2023Review
- The Techniques of Blood Purification in the Treatment of Sepsis and Other Hyperinflammatory Conditions.Journal of clinical medicine · 2023Review
- Adverse outcomes with extracorporeal adsorbent blood treatments in toxic systemic inflammation: a perspective on possible mechanisms.Annals of intensive care · 2022Review
- Coupled plasma filtration and adsorption for the treatment of septic shock.Intensive care medicine · 2022Article
- Renal Replacement Techniques in Septic Shock.International journal of molecular sciences · 2021Review
- Sepsis-Pathophysiology and Therapeutic Concepts.Frontiers in medicine · 2021Review
- [Extracorporeal techniques for blood purification in sepsis: an update].Der Internist · 2020Review
Corrections and comments
- Erratum issuedCorrection:2020
Authors and funding
20 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesCoupled 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.
designWe 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)).
settingBeing 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.
participantsBy 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).
interventionCPFA.
main outcome measuresHospital mortality at 28 days and 90 days follow-up.
resultsAfter 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.
conclusionWe 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.