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Mortality Reduction in Septic Shock by Plasma Adsorption (ROMPA)

Primary Purpose

Septic Shock

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
High Doses CPFA
Sponsored by
Francisco Colomina Climent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Hospital de Vinalopó
  • Hospital de la Vega Baja
  • Hospital Universitario de San Juan de Alicante
  • Hospital de Torrevieja
  • Hospital Marina Baixa
  • Hospital de la Plana
  • Hospital General Universitario de Santa Lucia
  • Hospital Frances De Borja de Gandia
  • Hospital Lluis Alcanyis
  • Hospital General Universitario de Alicante

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

High doses CPFA

Control Group

Arm Description

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

Standard practice

Outcomes

Primary Outcome Measures

Hospital mortality

Secondary Outcome Measures

time resolution of septic shock
normalization of lactate, and the decrease in vasoactive drugs

Full Information

First Posted
January 23, 2015
Last Updated
July 3, 2018
Sponsor
Francisco Colomina Climent
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1. Study Identification

Unique Protocol Identification Number
NCT02357433
Brief Title
Mortality Reduction in Septic Shock by Plasma Adsorption
Acronym
ROMPA
Official Title
Reduccion de la Mortalidad Mediante Plasma-Adsorción en Shock séptico (ROMPA)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Circumstances beyond the course of the trial have produced a change in the conditions of recruitment unacceptable to the ROMPA researchers
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Francisco Colomina Climent

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High doses CPFA
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Standard practice
Intervention Type
Device
Intervention Name(s)
High Doses CPFA
Primary Outcome Measure Information:
Title
Hospital mortality
Time Frame
28 days
Secondary Outcome Measure Information:
Title
time resolution of septic shock
Description
normalization of lactate, and the decrease in vasoactive drugs
Time Frame
within the first 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all patients admitted to the ICU in septic shock all patients that develop septic shock while in the ICU Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Colomina, MD
Organizational Affiliation
Hospital Universitario de San Juan de Alicante
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Vinalopó
City
Elche
State/Province
Alicante
ZIP/Postal Code
03293
Country
Spain
Facility Name
Hospital de la Vega Baja
City
Orihuela
State/Province
Alicante
ZIP/Postal Code
03300
Country
Spain
Facility Name
Hospital Universitario de San Juan de Alicante
City
Sant Joan d'Alacant
State/Province
Alicante
ZIP/Postal Code
03550
Country
Spain
Facility Name
Hospital de Torrevieja
City
Torrevieja
State/Province
Alicante
ZIP/Postal Code
03186
Country
Spain
Facility Name
Hospital Marina Baixa
City
Villajoyosa
State/Province
Alicante
Country
Spain
Facility Name
Hospital de la Plana
City
Villarreal
State/Province
Castellon
ZIP/Postal Code
12540
Country
Spain
Facility Name
Hospital General Universitario de Santa Lucia
City
Cartagena
State/Province
Murcia
ZIP/Postal Code
30202
Country
Spain
Facility Name
Hospital Frances De Borja de Gandia
City
Gandia
State/Province
Valencia
Country
Spain
Facility Name
Hospital Lluis Alcanyis
City
Xátiva
State/Province
Valencia
ZIP/Postal Code
46800
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31796477
Citation
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. Erratum In: BMJ Open. 2020 Mar 9;10(3):e030139corr1.
Results Reference
derived
PubMed Identifier
27406647
Citation
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.
Results Reference
derived

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Mortality Reduction in Septic Shock by Plasma Adsorption

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