Septic ShockPhase 3NCT02638545
Hemodynamic Effects of Dexmedetomidine in Septic Shock
A Phase 3 study testing Dexmedetomidine in people with Septic Shock, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The current treatment regimen of patients with septic shock requires a sufficient hemodynamic support aiming to preserve tissue oxygen requirements and perfusion. Therefore, aggressive fluid challenge and vasopressor agents play a pivotal role. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2015to Feb 2017
- Phase
- Phase 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- septic shock
- need for sedation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Italy1 site
Departement of Anesthesiology and Intensive Care of the University of Rome La Sapienza
Rome, 00161
About this study
Official title: Effects of Dexmedetomidine on Pressor Response to Norepinephrine in Patients With Septic Shock
The current treatment regimen of patients with septic shock requires a sufficient hemodynamic support aiming to preserve tissue oxygen requirements and perfusion. Therefore, aggressive fluid challenge and vasopressor agents play a pivotal role. To increase total peripheral resistance and preserve organ perfusion, a continuous infusion of catecholamines is often needed. Because sepsis is usually associated with adrenergic receptor and post-receptor abnormalities, the efficacy of such treatment regimens often gradually decreases over time, thereby complicating hemodynamic support. Experimental evidence suggest that α-2 agonists increase pressor responsiveness following lipopolysaccharide administration. This study will assess the effects of the sedation with dexmedetomidine (α-2 agonist) on norepinephrine requirements in patients with septic shock.
Read the detailed description
The present study was designed as a prospective study. All patients enrolled in the study will require norepinephrine to maintain MAP between 65 and 75 mmHg despite adequate volume resuscitation and will be sedated according to istitutional guidelines with propofol and remifentanyl. After 8 h had elapsed during stable hemodynamic conditions, an initial set of measurements will be obtained during the sedation with propofol and remifentanyl. This set of measurements will be considered as baseline. In the patients in which conventional sedation will be replaced by dexmedetomidine and remifentanyl, a second set of measurements will be obtained after 4 h had elapsed during stable conditions. A final set of mesurements will be obtained after another 8-h period in stable conditions after switcheing back again to propofol and remifentanyl, .
During the observational period the dosage rate of norepinephrine will be adjusted to maintain the same threshold MAP of 65-75 mmHg All other medications were held constant.
- Conditions
- Septic Shock
- Being tested
- Dexmedetomidine
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexdor
Sedation with propofol and remifentanyl will be replaced by a sedation with dexmedetomidine and remifentanyl
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Experimental | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
norepinephrine dose
Measured: 4 hours
Secondary outcomes (3)
cardiac output
Measured: 4 hours
mean arterial pressure
Measured: 4 hours
heart rate
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2017
- Study completionFeb 2017
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 University of Roma La SapienzaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Morelli, University of Roma La Sapienza
- Investigators
- Andrea Morelli, MD, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638545
- Sponsor's protocol ID
- 3820
- Status last verified
- Feb 2017
- First submitted
- 18 Dec 2015
- Last updated
- 8 Feb 2017
- 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 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine on Pressor Response to Norepinephrine in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT02638545
- Acronym / sponsor ID
- 3820
- Conditions
- Septic Shock
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 23 Dec 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 current treatment regimen of patients with septic shock requires a sufficient hemodynamic support aiming to preserve tissue oxygen requirements and perfusion. Therefore, aggressive fluid challenge and vasopressor agents play a pivotal role. To increase total peripheral resistance and preserve organ perfusion, a continuous infusion of catecholamines is often needed. Because sepsis is usually associated with adrenergic receptor and post-receptor abnormalities, the efficacy of such treatment regimens often gradually decreases over time, thereby complicating hemodynamic support. Experimental evidence suggest that α-2 agonists increase pressor responsiveness following lipopolysaccharide administration. This study will assess the effects of the sedation with dexmedetomidine (α-2 agonist) on norepinephrine requirements in patients with septic shock.
Detailed description
The present study was designed as a prospective study. All patients enrolled in the study will require norepinephrine to maintain MAP between 65 and 75 mmHg despite adequate volume resuscitation and will be sedated according to istitutional guidelines with propofol and remifentanyl. After 8 h had elapsed during stable hemodynamic conditions, an initial set of measurements will be obtained during the sedation with propofol and remifentanyl. This set of measurements will be considered as baseline. In the patients in which conventional sedation will be replaced by dexmedetomidine and remifentanyl, a second set of measurements will be obtained after 4 h had elapsed during stable conditions. A final set of mesurements will be obtained after another 8-h period in stable conditions after switcheing back again to propofol and remifentanyl, .
During the observational period the dosage rate of norepinephrine will be adjusted to maintain the same threshold MAP of 65-75 mmHg All other medications were held constant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Experimental | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- septic shock
- need for sedation
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| DexmedetomidineAlso: DexdorSedation with propofol and remifentanyl will be replaced by a sedation with dexmedetomidine and remifentanyl | Drug | dexmedetomidine |
Primary outcome
norepinephrine dose
Time frame: 4 hours
3 secondary outcomes
cardiac output
Time frame: 4 hours
mean arterial pressure
Time frame: 4 hours
heart rate
Time frame: 4 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 8 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
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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)
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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.
Andrea Morelli, MD principal investigator
University of Roma La Sapienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine in people with Septic Shock, run by University of Roma La Sapienza at 1 site in Italy.
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 1 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 8 Feb 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 Italy. 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.
What does this phase mean?
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 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?
norepinephrine dose (time frame: 4 hours). 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 8 Feb 2017.