Severe SepsisPhase 4NCT02109965
The Effect of Dexmedetomidine on Microcirculation in Severe Sepsis
A Phase 4 study testing Dexmedetomidine, Midazolam and Propofol in people with Severe Sepsis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Despite early goal-directed maintenance of normal macrocirculation, the reduction of 60-day mortality of patients with severe sepsis and septic shock remained unsatisfied (56.9% to 44.3%). One of the major causes of high mortality is microcirculatory dysfunction. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- Dexmedetomidine, Midazolam and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2014to 24 Feb 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU patients who require sedation
- Patients who have diagnosis of severe sepsis / septic shock
- meet 2 or more of the 4 SIRS criteria
- with one organ dysfunction according the definition of Surviving Sepsis Campaign
Who cannot join
- less than 20 y/o
- refractory bradycardia (heart rate slower than 60 bpm despite of adequate treatment)
- 2nd and 3rd degree of AV-block
- the onset of severe sepsis/septic shock is more than 24h before enrollment
- APACHE II > 30 at enrollment
- Severe liver cirrhosis (Child B or C)
Show all 18Show fewer
- New onset of myocardial infarction within 30 days or heart failure (NYHA 4)
- attend other trial in ICU within one month
- patient who is pregnant
- receive organ transplantation within one year
- expected survival is less than 30 days by attending physician
- receive cardiopulmonary resuscitation within 4 weeks
- patients who have signed consent of refusal of cardiopulmonary resuscitation and invasive therapy
- have allergic history to dexmedetomidine
- receive renal replacement therapy within 24 hours before enrollment
- patient with HIV infection
- non-native speaker
- other factors not eligible for enrollment concerned by attending physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dexmedetomidine on the Microcirculation in Patients With Severe Sepsis and Septic Shock
Despite early goal-directed maintenance of normal macrocirculation, the reduction of 60-day mortality of patients with severe sepsis and septic shock remained unsatisfied (56.9% to 44.3%). One of the major causes of high mortality is microcirculatory dysfunction. Delayed diagnosis and treatment of microcirculatory dysfunction may cause tissue hypoperfusion and resulted in multiple organ dysfunction and death. Dexmedetomidine is a highly selective α2-adrenoreceptor agonist which exhibits sedative and analgesic effects. Recent studies suggest that dexmedetomidine also has anti-coagulation and anti-inflammatory effects, and it can reduce the mortality of endotoxemic rats and patients with severe sepsis. The investigators will conduct two animal studies and one clinical trial to investigate the effect of dexmedetomidine on microcirculatory dysfunction and organ injury in rat with endotoxemia and patients with severe sepsis and septic shock.
Sixty patients with severe sepsis and septic shock will be enrolled and randomized to control group or dexmedetomidine group. In the control group, the patients will be treated according to the clinical practice guideline. If sedation is required, non-dexmedetomidine sedative agents will be used. In the dexmedetomidine group, the patients will be treated according to the clinical practice guideline, and they will also receive continuous infusion of dexmedetomidine (infusion rate ranged from 0.1 to 0.7 mcg/kg/h) for 24 hours as needed. The sublingual microcirculation, serum level of Endocan, NGAL(Neutrophil Gelatinase-Associated Lipocalin), and BNP(B-type natriuretic peptide) will be examined at preset time points up to 24 hours. The vital signs, hemodynamic parameters, and survival of 28-day and 90-day will be recorded and analyzed.
- Conditions
- Severe Sepsis
- Being tested
- Dexmedetomidine, Midazolam, Propofol
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Continue infusion (CIF) 0.1 - 0.7 mcg/kg/h Goal of sedation: Richmonad agitation-sedation scale 0 to -2
MidazolamDrug
Also called Dormicium
CIF Goal of sedation: Richmonad agitation-sedation scale 0 to -2
PropofolDrug
Also called Propofol-Lipuro
CIF Goal of sedation: Richmonad agitation-sedation scale 0 to -2
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Use midazolam or propofol for sedation Receives: Drug: Midazolam; Drug: Propofol |
| Dexmedetomidine | Experimental | Use dexmedetomidine for sedation Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of total small vessel density and perfused small vessel density
Measured: 6h
Secondary outcomes (2)
Changes of total small vessel density and perfused small vessel density
Measured: 24h
Change of microvascular flow index
Measured: 6h and 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startJul 2014
- Primary completion24 Feb 2016
- Study completion24 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chang Yeh, MD, PhD, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109965
- Sponsor's protocol ID
- 201311031MINB
- Status last verified
- Feb 2019
- First submitted
- 8 Apr 2014
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on the Microcirculation in Patients With Severe Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT02109965
- Acronym / sponsor ID
- 201311031MINB
- Conditions
- Severe Sepsis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 24 Feb 2016 (actual)
- Study completion
- 24 Feb 2018 (actual)
- First posted
- 10 Apr 2014 (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.
Despite early goal-directed maintenance of normal macrocirculation, the reduction of 60-day mortality of patients with severe sepsis and septic shock remained unsatisfied (56.9% to 44.3%). One of the major causes of high mortality is microcirculatory dysfunction. Delayed diagnosis and treatment of microcirculatory dysfunction may cause tissue hypoperfusion and resulted in multiple organ dysfunction and death. Dexmedetomidine is a highly selective α2-adrenoreceptor agonist which exhibits sedative and analgesic effects. Recent studies suggest that dexmedetomidine also has anti-coagulation and anti-inflammatory effects, and it can reduce the mortality of endotoxemic rats and patients with severe sepsis. The investigators will conduct two animal studies and one clinical trial to investigate the effect of dexmedetomidine on microcirculatory dysfunction and organ injury in rat with endotoxemia and patients with severe sepsis and septic shock.
Sixty patients with severe sepsis and septic shock will be enrolled and randomized to control group or dexmedetomidine group. In the control group, the patients will be treated according to the clinical practice guideline. If sedation is required, non-dexmedetomidine sedative agents will be used. In the dexmedetomidine group, the patients will be treated according to the clinical practice guideline, and they will also receive continuous infusion of dexmedetomidine (infusion rate ranged from 0.1 to 0.7 mcg/kg/h) for 24 hours as needed. The sublingual microcirculation, serum level of Endocan, NGAL(Neutrophil Gelatinase-Associated Lipocalin), and BNP(B-type natriuretic peptide) will be examined at preset time points up to 24 hours. The vital signs, hemodynamic parameters, and survival of 28-day and 90-day will be recorded and analyzed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Midazolam, Drug: PropofolUse midazolam or propofol for sedation |
| Dexmedetomidine | Experimental | Drug: DexmedetomidineUse dexmedetomidine for sedation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ICU patients who require sedation
- Patients who have diagnosis of severe sepsis / septic shock
- meet 2 or more of the 4 SIRS criteria
- with one organ dysfunction according the definition of Surviving Sepsis Campaign
Key exclusion criteria (18 listed)
- less than 20 y/o
- refractory bradycardia (heart rate slower than 60 bpm despite of adequate treatment)
- 2nd and 3rd degree of AV-block
- the onset of severe sepsis/septic shock is more than 24h before enrollment
- APACHE II > 30 at enrollment
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: PrecedexContinue infusion (CIF) 0.1 - 0.7 mcg/kg/h Goal of sedation: Richmonad agitation-sedation scale 0 to -2 | Drug | Dexmedetomidine |
| MidazolamAlso: DormiciumCIF Goal of sedation: Richmonad agitation-sedation scale 0 to -2 | Drug | Control |
| PropofolAlso: Propofol-LipuroCIF Goal of sedation: Richmonad agitation-sedation scale 0 to -2 | Drug | Control |
Primary outcome
Changes of total small vessel density and perfused small vessel density
Time frame: 6h
2 secondary outcomes
Changes of total small vessel density and perfused small vessel density
Time frame: 24h
Change of microvascular flow index
Time frame: 6h and 24h
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 4 Mar 2019.
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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.
Yu-Chang Yeh, MD, PhD study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine, Midazolam and Propofol in people with Severe Sepsis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 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: stopped early, as of the sponsor's last update on 4 Mar 2019. 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 Taiwan. 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 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 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?
Changes of total small vessel density and perfused small vessel density (time frame: 6h). 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 4 Mar 2019.