SepsisCascadeNCT00922870
Evaluation of Hemodynamic Effects of Cascade Hemofiltration in Septic Shock
A study testing Cascade and Standard treatment in people with Sepsis, run by Vantive Health LLC at 5 sites in France.
Trial summary
Septic shock is a major cause of mortality and morbidity in critically ill patients. Septic Shock is associated with an overwhelming, systemic overflow of pro inflammatory and anti-inflammatory mediators, which leads to generalized endothelial damage, multiple organ failure, and altered cellular immunological… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Cascade and Standard treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesFrance
- Study dates
- Apr 2009to Mar 2013
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a septic shock diagnosed by the medical staff team.
- Patient mechanically ventilated and treated by high doses of catecholamines after adequate fluid administration (≥ 1.0 mg/h of norepinephrine or epinephrine) for ≥ 120 minutes and < 24h.
Who cannot join
- Age (years) < 18 or > 85.
- Weight >120 kg
- Thrombocytopenia 50< G/l or Neutrophils <0.5 Giga/l
- Contra indication to heparin anticoagulation.
- Patient requiring catecholamines (epinephrine ≥ 1 mg/h or norepinephrine ≥ 1 mg/h) for >24h.
- Patient admitted to the ICU ≥ 7 days before the inclusion criteria.
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- Comorbid conditions with an expected survival < 6 months
- Inclusion (<28 days) in another study interfering with the goals of the current investigation.
- Pregnancy
- Immune compromised patients (e.g. being treated for cancer, treated by immunosuppressors or steroids, AIDS).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU hospital
Clermont-Ferrand, 63003
Hopital Le Bocage
Dijon, 21079
Centre Hospitalier Marc JACQUET
Melun, 77 000
Hopital Tenon
Paris, 75020
Hopital Delafontaine
Saint-Denis, 93205
About this study
Septic shock is a major cause of mortality and morbidity in critically ill patients. Septic Shock is associated with an overwhelming, systemic overflow of pro inflammatory and anti-inflammatory mediators, which leads to generalized endothelial damage, multiple organ failure, and altered cellular immunological responsiveness. Although our understanding of the complex pathophysiological alterations that occur in septic shock has increased greatly as a result of recent clinical and preclinical studies, mortality associated with the disorder remains unacceptably high, ranging from 30% to 50%. To date, attempts to improve survival with innovative, predominantly anti-inflammatory therapeutic strategies have been disappointing. A standard hemofiltration rate of 35 ml/kg/hour has been successfully used to treat acute renal failure. However, this dose does not alter plasma levels of inflammatory mediators, suggesting that its ability to clear these mediators is suboptimal. Higher doses of hemofiltration (up to 120 ml/kg per hour) have been demonstrated to improve cardiac function and hemodynamics in several animal models of sepsis. High-volume hemofiltration (HVHF) was thus conceived and applied in patients with septic shock, showing an improvements in hemodynamics with decreased vasopressor requirements and improved survival in patients admitted after a cardiac arrest.
The main benefit described with high volume hemofiltration is a hemodynamic improvement (e.g reduction in catecholamines' requirement). This improvement seems to be due to the removal of a badly defined network of middle molecular weight peptides. To remove efficiently these middle molecular peptides, a high filtration rate is needed. However, with high filtration rates, there is also a high clearance for smaller molecules, including antibiotics, electrolytes, vitamins, trace elements and amino acids.
Read more
The cascade hemofiltration system has been designed for a more efficient removal of middle molecular weight peptides with a limited solute consumption.
The goal of this study is the evaluation of the hemodynamic improvement using cascade hemofiltration in patients treated for septic shock.
- Conditions
- Sepsis
- Being tested
- Cascade, Standard treatment
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CascadeDevice
Cascade treatment over 48h
Standard treatmentOther
Standard therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Active comparator | Not described Receives: Other: Standard treatment |
| Cascade | Experimental | Not described Receives: Device: Cascade |
What is being measured
The primary outcome is the main question the study is designed to answer.
the primary outcome will be the number of days without catecholamines at the 28th day of randomization
Measured: 28th day
Secondary outcomes (1)
rate of decrease of catecholamines during the first 72h, days without mechanical ventilation at D90, days without RRT for acute renal failure at D90, days without ICU requirement at D90, status at D90.
Measured: 72h, D90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2013
- Study completionMar 2013
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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gambro Lundia AB, Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Monchi Mehran, Dr, Study chair, Unaffiliate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922870
- Sponsor's protocol ID
- 1450
- Acronym
- Cascade
- Status last verified
- Mar 2025
- First submitted
- 15 Jun 2009
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hemodynamic Effects of Cascade Hemofiltration in Septic Shock
- ClinicalTrials.gov ID
- NCT00922870
- Acronym / sponsor ID
- Cascade / 1450
- Conditions
- Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Gambro Lundia AB, Baxter Healthcare Corporation
- Study start
- Apr 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 Jun 2009 (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.
Septic shock is a major cause of mortality and morbidity in critically ill patients. Septic Shock is associated with an overwhelming, systemic overflow of pro inflammatory and anti-inflammatory mediators, which leads to generalized endothelial damage, multiple organ failure, and altered cellular immunological responsiveness. Although our understanding of the complex pathophysiological alterations that occur in septic shock has increased greatly as a result of recent clinical and preclinical studies, mortality associated with the disorder remains unacceptably high, ranging from 30% to 50%. To date, attempts to improve survival with innovative, predominantly anti-inflammatory therapeutic strategies have been disappointing. A standard hemofiltration rate of 35 ml/kg/hour has been successfully used to treat acute renal failure. However, this dose does not alter plasma levels of inflammatory mediators, suggesting that its ability to clear these mediators is suboptimal. Higher doses of hemofiltration (up to 120 ml/kg per hour) have been demonstrated to improve cardiac function and hemodynamics in several animal models of sepsis. High-volume hemofiltration (HVHF) was thus conceived and applied in patients with septic shock, showing an improvements in hemodynamics with decreased vasopressor requirements and improved survival in patients admitted after a cardiac arrest.
The main benefit described with high volume hemofiltration is a hemodynamic improvement (e.g reduction in catecholamines' requirement). This improvement seems to be due to the removal of a badly defined network of middle molecular weight peptides. To remove efficiently these middle molecular peptides, a high filtration rate is needed. However, with high filtration rates, there is also a high clearance for smaller molecules, including antibiotics, electrolytes, vitamins, trace elements and amino acids.
The cascade hemofiltration system has been designed for a more efficient removal of middle molecular weight peptides with a limited solute consumption.
The goal of this study is the evaluation of the hemodynamic improvement using cascade hemofiltration in patients treated for septic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Other: Standard treatment |
| Cascade | Experimental | Device: Cascade |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with a septic shock diagnosed by the medical staff team.
- Patient mechanically ventilated and treated by high doses of catecholamines after adequate fluid administration (≥ 1.0 mg/h of norepinephrine or epinephrine) for ≥ 120 minutes and < 24h.
Key exclusion criteria (10 listed)
- Age (years) < 18 or > 85.
- Weight >120 kg
- Thrombocytopenia 50< G/l or Neutrophils <0.5 Giga/l
- Contra indication to heparin anticoagulation.
- Patient requiring catecholamines (epinephrine ≥ 1 mg/h or norepinephrine ≥ 1 mg/h) for >24h.
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 |
|---|---|---|
| CascadeCascade treatment over 48h | Device | Cascade |
| Standard treatmentStandard therapy | Other | Standard treatment |
Primary outcome
the primary outcome will be the number of days without catecholamines at the 28th day of randomization
Time frame: 28th day
1 secondary outcome
rate of decrease of catecholamines during the first 72h, days without mechanical ventilation at D90, days without RRT for acute renal failure at D90, days without ICU requirement at D90, status at D90.
Time frame: 72h, D90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
Related trials for Sepsis
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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.
Monchi Mehran, Dr study chair
Unaffiliate
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cascade and Standard treatment in people with Sepsis, run by Vantive Health LLC at 5 sites in France.
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 10 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: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the primary outcome will be the number of days without catecholamines at the 28th day of randomization (time frame: 28th day). 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 13 Mar 2025.