Septic ShockPhase 2/3CATACHOCNCT01856517
Upregulation of Alpha-1 Receptors Upon Septic Shock?
A Phase 2/3 study testing Clonidine in people with Septic Shock, run by Direction Centrale du Service de Santé des Armées at 1 site in France.
Trial summary
The hallmarks of septic shock are hypovolemia and reduced pressor response to endogenous noradrenaline. The working hypothesis is that the higher the plasma concentration of endogenous noradrenaline will be, the lower the pressor response to exogenous noradrenaline will be. 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?
- Clonidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2013to Sep 2014
- Phase
- Phase 2/3
- 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 presenting to the CCU with septic shock : SBP<90 mm Hg refractory to volume load (>30 ml.kg-1 within 6 h before inclusion) thus in need administration of noradrenaline for >1 h (0.1 mcg.kg-1.h-1 i.e. >0.5 mg.h-1/70 kg) to maintain mean BP>65 mm Hg.
- criteria for sepsis :temperature>38.5 or <36°C ; WBC>12 000 or <4000/ml ; tachypnea (>20 cycles par min) or mechanical ventilation ; tachycardia : >90 bpmin
- written informed consent by the patient or next of kin or signature by the investigators of the form "emergency inclusion"
Who cannot join
- age<18 ans
- pregnancy
- mental illness making informed consent impossible
- Absence of consent as signed by the patient or next of kin or signature of "emergency inclusion form"
- individual without social security coverage or participating in another biomedical research
- Contre-indications to clonidine (uncorrected hypovolemia, sick sinus syndrom, III grade AV block)
- HR<70 bp/min
- pre-exitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Up Regulation of Alpha-1 Receptors Upon Septic Shock ?
The hallmarks of septic shock are hypovolemia and reduced pressor response to endogenous noradrenaline. The working hypothesis is that the higher the plasma concentration of endogenous noradrenaline will be, the lower the pressor response to exogenous noradrenaline will be. This will be tested in patients presenting with septic shock, following state of the art management (including repeated assessment of vena cava diameter and compliance, and response to dynamic indices of loading) following placebo vs clonidine administration (1 mcg.kg-1.h-1 over 24 h without bolus) and administration of increasing doses of noradrenaline (1 mcg, 2 mcg, etc. up to a delta systolic blood pressure circa 25-30 mm Hg).
- Conditions
- Septic Shock
- Being tested
- Clonidine, Placebo
- Keywords
- pressor response, chronotropic response
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClonidineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | saline administration over 24 h following full optimization of patient according to current guidelines Receives: Drug: Placebo |
| clonidine | Active comparator | clonidine 1 mcg.kg-1.h-1 over 24 h following full optimization of the patient according to current guidelines Receives: Drug: Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pressor response to exogenous noradrenaline
bolus of exogenous noradrenaline (1 mcg and up) are administered to the patient to evoke an increase in delta systolic blood pressure by 25-30 mm Hg. Administration of increasing dose of noradrenaline is stopped as soon as delta systolic blood pressure has reached 25-30 mm Hg.
Measured: 0 and 24 h
Secondary outcomes (1)
change in heart rate response to increasing doses of dobutamine (100 mcg and up) to evoke an increase in heart rate up to 20 beats per min.
Measured: 0 and 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2013
- Study completionSep 2014
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.
- 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Dardare, Direction Centrale du Service de Santé des Armées
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856517
- Sponsor's protocol ID
- 2011PPRC01TURC
- Acronym
- CATACHOC
- Status last verified
- Jul 2017
- First submitted
- 19 Apr 2013
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Up Regulation of Alpha-1 Receptors Upon Septic Shock ?
- ClinicalTrials.gov ID
- NCT01856517
- Acronym / sponsor ID
- CATACHOC / 2011PPRC01TURC
- Conditions
- Septic Shock
- Keywords
- pressor response, chronotropic response
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 May 2013 (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 hallmarks of septic shock are hypovolemia and reduced pressor response to endogenous noradrenaline. The working hypothesis is that the higher the plasma concentration of endogenous noradrenaline will be, the lower the pressor response to exogenous noradrenaline will be. This will be tested in patients presenting with septic shock, following state of the art management (including repeated assessment of vena cava diameter and compliance, and response to dynamic indices of loading) following placebo vs clonidine administration (1 mcg.kg-1.h-1 over 24 h without bolus) and administration of increasing doses of noradrenaline (1 mcg, 2 mcg, etc. up to a delta systolic blood pressure circa 25-30 mm Hg).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebosaline administration over 24 h following full optimization of patient according to current guidelines |
| clonidine | Active comparator | Drug: Clonidineclonidine 1 mcg.kg-1.h-1 over 24 h following full optimization of the patient according to current guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients presenting to the CCU with septic shock : SBP<90 mm Hg refractory to volume load (>30 ml.kg-1 within 6 h before inclusion) thus in need administration of noradrenaline for >1 h (0.1 mcg.kg-1.h-1 i.e. >0.5 mg.h-1/70 kg) to maintain mean BP>65 mm Hg.
- criteria for sepsis :temperature>38.5 or <36°C ; WBC>12 000 or <4000/ml ; tachypnea (>20 cycles par min) or mechanical ventilation ; tachycardia : >90 bpmin
- written informed consent by the patient or next of kin or signature by the investigators of the form "emergency inclusion"
Key exclusion criteria (8 listed)
- age<18 ans
- pregnancy
- mental illness making informed consent impossible
- Absence of consent as signed by the patient or next of kin or signature of "emergency inclusion form"
- individual without social security coverage or participating in another biomedical research
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 |
|---|---|---|
| Clonidine | Drug | clonidine |
| Placebo | Drug | placebo |
Primary outcome
change in pressor response to exogenous noradrenaline
Time frame: 0 and 24 h
bolus of exogenous noradrenaline (1 mcg and up) are administered to the patient to evoke an increase in delta systolic blood pressure by 25-30 mm Hg. Administration of increasing dose of noradrenaline is stopped as soon as delta systolic blood pressure has reached 25-30 mm Hg.
1 secondary outcome
change in heart rate response to increasing doses of dobutamine (100 mcg and up) to evoke an increase in heart rate up to 20 beats per min.
Time frame: 0 and 24 h
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Clonidine in people with Septic Shock, run by Direction Centrale du Service de Santé des Armées at 1 site 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 3 inclusion and 8 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 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. 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?
change in pressor response to exogenous noradrenaline (time frame: 0 and 24 h). 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 28 Jul 2017.