SepsisSAMOF-TPENCT03844542
Therapeutic Plasma Exchange in the Treatment of Sepsis Associated Multi-Organ Failure [SAMOF-TPE]
A study testing Therapeutic plasma exchange in people with Sepsis, run by Forsyth Medical Center.
Trial summary
The investigators prospective, randomized adult clinical trial investigates the therapeutic efficacy of early therapeutic plasma exchange as adjunct treatment to standard therapy in patients with refractory septic shock and multiple organ failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Therapeutic plasma exchange
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to Jun 2023
- 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
- Adult patients are eligible for inclusion if they have sepsis with refractory shock and evidence of organ failure.
Who cannot join
- Persons who are pregnant
- Persons who are incarcerated
- Acute surgical catastrophe without potential for intervention or source control
- Cardiac arrest with unknown neurologic status, including patients being treated with therapeutic hypothermia
- Presence of severe acute brain injury or severe dementia
- Cardiogenic, neurogenic, obstructive, or post-cardiotomy shock
Show all 18Show fewer
- Acute pancreatitis with no established source of infection
- Diabetic ketoacidosis as primary pathology
- Note: Septic patients who develop DKA are eligible for inclusion. However, patients in whom organ dysfunction and hemodynamic instability are due primarily to volume depletion and acidosis from DKA should not be included.
- Need for mechanical circulatory support
- Prolonged acute illness with > 24 hours of pressor needs at enrollment and/or end organ damage with further care deemed to be "futile."
- NOTE: The time resets if a new inciting event leads to SAMOF.
- For example, if a patient has sepsis stabilized but requires operative intervention for source control within the initial 24 hours of admission and returns to the ICU with SAMOF, the patient is again eligible for randomization for the next 24 hours.
- Bedbound state or poor baseline functional status with ECOG performance status score ≥ 3
- Underlying terminal illness/malignancy with < 6 months life expectancy
- Advanced chronic liver disease/cirrhosis with evidence of portal hypertension
- Asplenia
- HIV with HARRT non-compliance
Trial locations and contacts
No sites are listed yet.
About this study
The investigators prospective, randomized adult clinical trial investigates the therapeutic efficacy of early therapeutic plasma exchange as adjunct treatment to standard therapy in patients with refractory septic shock and multiple organ failure.
- Conditions
- Sepsis
- Being tested
- Therapeutic plasma exchange
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic plasma exchangeDevice
Perform therapeutic plasma exchange in patients with sepsis induced multi-organ failure
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic plasma exchange | Experimental | Perform therapeutic plasma exchange in addition to standard care for patients with sepsis induced multi-organ failure Receives: Device: Therapeutic plasma exchange |
| Standard care alone for sepsis | No intervention | Standard care for patients with sepsis induced multi-organ failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-Day Mortality
28 days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study startJun 2019 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Forsyth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844542
- Sponsor's protocol ID
- 18-1187
- Acronym
- SAMOF-TPE
- Status last verified
- Feb 2019
- First submitted
- 15 Feb 2019
- Last updated
- 18 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Plasma Exchange in the Treatment of Sepsis Associated Multi-Organ Failure [SAMOF-TPE]
- ClinicalTrials.gov ID
- NCT03844542
- Acronym / sponsor ID
- SAMOF-TPE / 18-1187
- Conditions
- Sepsis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Forsyth Medical CenterUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 18 Feb 2019 (actual)
- 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 investigators prospective, randomized adult clinical trial investigates the therapeutic efficacy of early therapeutic plasma exchange as adjunct treatment to standard therapy in patients with refractory septic shock and multiple organ failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic plasma exchange | Experimental | Device: Therapeutic plasma exchangePerform therapeutic plasma exchange in addition to standard care for patients with sepsis induced multi-organ failure |
| Standard care alone for sepsis | No intervention | –Standard care for patients with sepsis induced multi-organ failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients are eligible for inclusion if they have sepsis with refractory shock and evidence of organ failure.
Key exclusion criteria (18 listed)
- Persons who are pregnant
- Persons who are incarcerated
- Acute surgical catastrophe without potential for intervention or source control
- Cardiac arrest with unknown neurologic status, including patients being treated with therapeutic hypothermia
- Presence of severe acute brain injury or severe dementia
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 |
|---|---|---|
| Therapeutic plasma exchangePerform therapeutic plasma exchange in patients with sepsis induced multi-organ failure | Device | Therapeutic plasma exchange |
Primary outcome
28-Day Mortality
Time frame: 28 days
28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic plasma exchange in people with Sepsis, run by Forsyth Medical Center.
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 1 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip Keith, MD (843.693.0412, pkeith@salemchest.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-Day 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?
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 18 Feb 2019.