Septic ShockPhase 4PCANCT02885168
Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C
A Phase 4 study testing Recombinant Activated Protein C, Near-infrared spectroscopy (NIRS) and Phenylephrine in people with Septic Shock, run by Central Hospital, Nancy, France.
Trial summary
The purpose is to demonstrate that vasoreactivity of patients with septic shock evaluated with dose-response curve is diminished in septic shock and ameliorated by activated protein C (APC). 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?
- Recombinant Activated Protein C, Near-infrared spectroscopy (NIRS) and Phenylephrine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Apr 2009
- Phase
- Phase 4
- 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
- Patients with septic shock as determined by standard criteria (including infection and severe infection)
Who cannot join
- Pregnant women
- Absence of signed informed consent. Due to gravity of medical situation of patients, inclusion will be possible after informed consent of a family member. As soon as possible, an informed consent will be obtained by patient
- Contraindication to Xigris: evolutive internal bleeding , intracranial pathology, neoplasia or brain involvement, concomitant heparin therapy >= 15 IU/kg/h, known hemorrhagic diathesis except acute coagulopathy subsequent to sepsis, severe chronic liver disease, platelet count < 30000 x 10^6/L, high bleeding risk, known hypersensibility to drotrecogin alfa (activated), one of excipients or bovine thrombin
About this study
The purpose is to demonstrate that vasoreactivity of patients with septic shock evaluated with dose-response curve is diminished in septic shock and ameliorated by activated protein C (APC).
This amelioration is correlated to decrease of inflammation, decrease of reactive oxygen species (ROS) markers and increase of circulating catecholamines.
- Conditions
- Septic Shock
- Being tested
- Recombinant Activated Protein C, Near-infrared spectroscopy (NIRS), Phenylephrine, Blood sample
- Keywords
- vasoreactivity, recombinant activated protein C
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Activated Protein CDrug
Also called Xigris
24 μg/kg/h during 96 hours - intravenous injection
Near-infrared spectroscopy (NIRS)Device
After baseline measurement, cuff is blown up to obtain a muscular saturation at 40% and then deflated. Reactive hyperthermia is measured. It is considered as an index for endothelial function.
PhenylephrineDrug
Continuous administration of phenylephrine with electric syringe with increasing dosing levels: 0.0; 0.02; 0.05; 0.1; 0.2; 0.5; 0.75; 1.00; 1.50; 3.00; 4.50; 6.00; 9.00 et 12 µg/kg/min. Each level is maintained for 5 minutes. Administration of phenylephrine is stopped progressively with the same schema.
Arterial tension through an invasive approach is measured during the test.
Blood sampleBiological
Analysis of inflammation and cellular adhesion markers and free radicals
| Study group | Role | What they receive |
|---|---|---|
| Shock + Treatment | Experimental | Patients treated with activated protein C Receives: Drug: Recombinant Activated Protein C; Device: Near-infrared spectroscopy (NIRS); Drug: Phenylephrine; Biological: Blood sample |
| Shock | Other | Patients not treated with activated protein C Receives: Device: Near-infrared spectroscopy (NIRS); Drug: Phenylephrine; Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular reactivity measured with dose-response to phenylephrine
Measured: baseline
Vascular reactivity measured with dose-response to phenylephrine
Measured: 4 hours
Vascular reactivity measured with dose-response to phenylephrine
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startFeb 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno LEVY, Principal investigator, Réanimation Médicale - Hôpital de Brabois - CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885168
- Sponsor's protocol ID
- 2007-002319-16
- Acronym
- PCA
- Status last verified
- Aug 2016
- First submitted
- 26 Aug 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C
- ClinicalTrials.gov ID
- NCT02885168
- Acronym / sponsor ID
- PCA / 2007-002319-16
- Conditions
- Septic Shock
- Keywords
- vasoreactivity, recombinant activated protein C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 31 Aug 2016 (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 purpose is to demonstrate that vasoreactivity of patients with septic shock evaluated with dose-response curve is diminished in septic shock and ameliorated by activated protein C (APC).
This amelioration is correlated to decrease of inflammation, decrease of reactive oxygen species (ROS) markers and increase of circulating catecholamines.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shock + Treatment | Experimental | Drug: Recombinant Activated Protein C, Device: Near-infrared spectroscopy (NIRS), Drug: Phenylephrine, Biological: Blood samplePatients treated with activated protein C |
| Shock | Other | Device: Near-infrared spectroscopy (NIRS), Drug: Phenylephrine, Biological: Blood samplePatients not treated with activated protein C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with septic shock as determined by standard criteria (including infection and severe infection)
Key exclusion criteria (3 listed)
- Pregnant women
- Absence of signed informed consent. Due to gravity of medical situation of patients, inclusion will be possible after informed consent of a family member. As soon as possible, an informed consent will be obtained by patient
- Contraindication to Xigris: evolutive internal bleeding , intracranial pathology, neoplasia or brain involvement, concomitant heparin therapy >= 15 IU/kg/h, known hemorrhagic diathesis except acute coagulopathy subsequent to sepsis, severe chronic liver disease, platelet count < 30000 x 10^6/L, high bleeding risk, known hypersensibility to drotrecogin alfa (activated), one of excipients or bovine thrombin
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 |
|---|---|---|
| Recombinant Activated Protein CAlso: Xigris24 μg/kg/h during 96 hours - intravenous injection | Drug | Shock + Treatment |
| Near-infrared spectroscopy (NIRS)After baseline measurement, cuff is blown up to obtain a muscular saturation at 40% and then deflated. Reactive hyperthermia is measured. It is considered as an index for endothelial function. | Device | Shock, Shock + Treatment |
| PhenylephrineContinuous administration of phenylephrine with electric syringe with increasing dosing levels: 0.0; 0.02; 0.05; 0.1; 0.2; 0.5; 0.75; 1.00; 1.50; 3.00; 4.50; 6.00; 9.00 et 12 µg/kg/min. Each level is maintained for 5 minutes. Administration of phenylephrine is stopped progressively with the same schema. Arterial tension through an invasive approach is measured during the test. | Drug | Shock, Shock + Treatment |
| Blood sampleAnalysis of inflammation and cellular adhesion markers and free radicals | Biological | Shock, Shock + Treatment |
Primary outcome
Vascular reactivity measured with dose-response to phenylephrine
Time frame: baseline
Vascular reactivity measured with dose-response to phenylephrine
Time frame: 4 hours
Vascular reactivity measured with dose-response to phenylephrine
Time frame: 24 hours
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 31 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
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.
Bruno LEVY principal investigator
Réanimation Médicale - Hôpital de Brabois - CHRU Nancy
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Recombinant Activated Protein C, Near-infrared spectroscopy (NIRS) and Phenylephrine in people with Septic Shock, run by Central Hospital, Nancy, 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 1 inclusion and 3 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 31 Aug 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Vascular reactivity measured with dose-response to phenylephrine (time frame: baseline). The study lists 3 primary outcomes in all. 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 31 Aug 2016.