Septic ShockROMPANCT02357433
Mortality Reduction in Septic Shock by Plasma Adsorption
A study testing High Doses CPFA in people with Septic Shock, run by Francisco Colomina Climent at 10 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- High Doses CPFA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 10 sitesSpain
- Study dates
- Feb 2015to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients admitted to the ICU in septic shock
- all patients that develop septic shock while in the ICU
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital General Universitario de Santa Lucia
Cartagena, Murcia, 30202
Hospital de Vinalopó
Elche, Alicante, 03293
Hospital Frances De Borja de Gandia
Gandia, Valencia
Hospital de la Vega Baja
Orihuela, Alicante, 03300
Hospital Universitario de San Juan de Alicante
Sant Joan d'Alacant, Alicante, 03550
Hospital de Torrevieja
Torrevieja, Alicante, 03186
Hospital Marina Baixa
Villajoyosa, Alicante
Hospital de la Plana
Villarreal, Castellon, 12540
Hospital Lluis Alcanyis
Xátiva, Valencia, 46800
About this study
Official title: Reduccion de la Mortalidad Mediante Plasma-Adsorción en Shock séptico (ROMPA)
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).
- Conditions
- Septic Shock
- Being tested
- High Doses CPFA
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Doses CPFADevice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: High Doses CPFA |
| Control Group | No intervention | Standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
Measured: 28 days
Secondary outcomes (1)
time resolution of septic shock
normalization of lactate, and the decrease in vasoactive drugs
Measured: within the first 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2018
- Study completionJun 2018
Why it stopped: Circumstances beyond the course of the trial have produced a change in the conditions of recruitment unacceptable to the ROMPA researchers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francisco Colomina Climent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francisco Colomina Climent, Hospital Universitario San Juan de Alicante
- Investigators
- Francisco Colomina, MD, Principal investigator, Hospital Universitario de San Juan de Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357433
- Sponsor's protocol ID
- 01-2015_R
- Acronym
- ROMPA
- Status last verified
- Jul 2018
- First submitted
- 23 Jan 2015
- Last updated
- 6 Jul 2018
- Results posted
- No
Publications
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.
PubMed 31796477Colomina-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.
PubMed 27406647
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduccion de la Mortalidad Mediante Plasma-Adsorción en Shock séptico (ROMPA)
- ClinicalTrials.gov ID
- NCT02357433
- Acronym / sponsor ID
- ROMPA / 01-2015_R
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Circumstances beyond the course of the trial have produced a change in the conditions of recruitment unacceptable to the ROMPA researchers
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Francisco Colomina ClimentUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High doses CPFA | Experimental | Device: High Doses CPFAHigh 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 |
| Control Group | No intervention | –Standard practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all patients admitted to the ICU in septic shock
- all patients that develop septic shock while in the ICU
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Doses CPFA | Device | High doses CPFA |
Primary outcome
Hospital mortality
Time frame: 28 days
1 secondary outcome
time resolution of septic shock
Time frame: within the first 28 days
Results and safety
The study was stopped early (reason given: Circumstances beyond the course of the trial have produced a change in the conditions of recruitment unacceptable to the ROMPA researchers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Derived from this study: PubMed 31796477Gimenez-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.
- Derived from this study: PubMed 27406647Colomina-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco Colomina, MD principal investigator
Hospital Universitario de San Juan de Alicante
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Doses CPFA in people with Septic Shock, run by Francisco Colomina Climent at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Circumstances beyond the course of the trial have produced a change in the conditions of recruitment unacceptable to the ROMPA researchers). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02357433, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.