NCT02357433

Brief Summary

The study objective is to clarify whether the application of high doses CPFA (Coupled Plasma-Filtration Adsorption) in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit (ICU).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

3.3 years

First QC Date

January 23, 2015

Last Update Submit

July 3, 2018

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

  • Hospital mortality

    28 days

Secondary Outcomes (1)

  • time resolution of septic shock

    within the first 28 days

Study Arms (2)

High doses CPFA

EXPERIMENTAL

High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): \>0.20 L/kg/day of plasma treated in the first 3 days after randomization

Device: High Doses CPFA

Control Group

NO INTERVENTION

Standard practice

Interventions

High Doses CPFADEVICE
High doses CPFA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients admitted to the ICU in septic shock
  • all patients that develop septic shock while in the ICU

You may not qualify if:

  • Age less than 18 years
  • Pregnancy
  • Estimated life expectancy (due to comorbidities) less than 90 days
  • Presence of relative or absolute contraindications to CPFA
  • Absence of informed consen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hospital de Vinalopó

Elche, Alicante, 03293, Spain

Location

Hospital de la Vega Baja

Orihuela, Alicante, 03300, Spain

Location

Hospital Universitario de San Juan de Alicante

Sant Joan d'Alacant, Alicante, 03550, Spain

Location

Hospital de Torrevieja

Torrevieja, Alicante, 03186, Spain

Location

Hospital Marina Baixa

Villajoyosa, Alicante, Spain

Location

Hospital de la Plana

Villarreal, Castellon, 12540, Spain

Location

Hospital General Universitario de Santa Lucia

Cartagena, Murcia, 30202, Spain

Location

Hospital Frances De Borja de Gandia

Gandia, Valencia, Spain

Location

Hospital Lluis Alcanyis

Xátiva, Valencia, 46800, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Related Publications (2)

  • Gimenez-Esparza C, Portillo-Requena C, Colomina-Climent F, Allegue-Gallego JM, Galindo-Martinez M, Molla-Jimenez C, Anton-Pascual JL, Marmol-Peis E, Dolera-Moreno C, Rodriguez-Serra M, Martin-Ruiz JL, Fernandez-Arroyo PJ, Blasco-Ciscar EM, Canovas-Robles J, Gonzalez-Hernandez E, Sanchez-Moran F, Solera-Suarez M, Torres-Tortajada J, Palazon-Bru A, Gil-Guillen VF. The premature closure of ROMPA clinical trial: mortality reduction in septic shock by plasma adsorption. BMJ Open. 2019 Dec 3;9(12):e030139. doi: 10.1136/bmjopen-2019-030139.

    PMID: 31796477DERIVED

  • Colomina-Climent F, Gimenez-Esparza C, Portillo-Requena C, Allegue-Gallego JM, Galindo-Martinez M, Molla-Jimenez C, Anton-Pascual JL, Rodriguez-Serra M, Martin-Ruiz JL, Fernandez-Arroyo PJ, Blasco-Ciscar EM, Canovas-Robles J, Herrera-Murillo M, Gonzalez-Hernandez E, Sanchez-Moran F, Solera-Suarez M, Torres-Tortajada J, Nunez-Martinez JM, Martin-Langerwerf D, Herrero-Gutierrez E, Sebastian-Munoz I, Palazon-Bru A, Gil-Guillen VF. Mortality Reduction in Septic Shock by Plasma Adsorption (ROMPA): a protocol for a randomised clinical trial. BMJ Open. 2016 Jul 12;6(7):e011856. doi: 10.1136/bmjopen-2016-011856.

    PMID: 27406647DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Francisco Colomina, MD

    Hospital Universitario de San Juan de Alicante

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 23, 2015

First Posted

February 6, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

July 6, 2018

Record last verified: 2018-07

Locations

ES(10)