Septic ShockNCT03434691
Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients
A study testing Microdialysis Probe (Muscle microdialysis) and remifentanyl in people with Septic Shock, run by Military Hospital of Tunis at 2 sites in Tunisia.
Trial summary
To investigate changes in the concentration of glucose, lactate, pyruvate and glycerol in the extracellular fluid of the skeletal muscle following Dexmedetomidine administration in patients with septic shock. 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?
- Microdialysis Probe (Muscle microdialysis) and remifentanyl
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTunisia
- Study dates
- 8 Feb 2018to 31 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 years
- Septic shock requiring norepinephrine (NE) to maintain a mean arterial pressure (MAP) of at least 65mm Hg despite appropriate volume resuscitation (fluid challenge of 20 mL/kg-40 mL/kg)
- Septic shock criteria were defined according to the new Sepsis-3 definition
Who cannot join
- pregnancy
- uncontrolled hemorrhage
- terminal heart failure
- significant valvular heart disease
- documented or suspected acute coronary syndrome, and limitations on the use of inotropes: left ventricle outflow obstruction, systolic anterior motion of the mitral valve
- refractory bradycardia (heart rate slower than 60 bpm despite of adequate treatment)
Show all 12Show fewer
- 2nd and 3rd degree of AV-block ,the onset of septic shock more than 24 h before enrollment ,
- APACHE II > 30 at enrollment
- Severe liver cirrhosis (Child B or C)
- New onset of myocardial infarction within 30 days or heart failure (NYHA 4)
- attending other trial in ICU within one month
- allergic history to dexmedetomidine
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites, 2 recruiting
- Recruiting
Military hospital of tunis
Tunis, Mont Fleury, 1008
zied hajjej, Dr, +21620358907, hajjej_zied@hotmail.com
zied hajjej, dr
- Recruiting
Military Hopital of Tunis
Tunis, 1008
mustapha ferjani, 98329256, mustapha.ferjani@planet.tn
zied hajjej, 20358907, hajjej_zied@hotmail.com
About this study
Official title: Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients: a Muscle Microdialysis Study
To investigate changes in the concentration of glucose, lactate, pyruvate and glycerol in the extracellular fluid of the skeletal muscle following Dexmedetomidine administration in patients with septic shock.
Read the detailed description
Prospective randomized double blinded study. Investigators planned to enroll 60 cases diagnosed with septic shock All patients will be sedated with Midazolam and remifentanyl in accordance with a local unit protocol.
After a period of six hours of hemodynamic stability, patients were randomized to receive either continuous infusion of Dexmedetomidine at 0.4 μg/kg per hour and remifentanyl (DEX group) or a continuous infusion of a Midazolam and remifentanyl (MDZ Group).
- Conditions
- Septic Shock
- Being tested
- Microdialysis Probe (Muscle microdialysis), remifentanyl
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microdialysis Probe (Muscle microdialysis)Device
Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were determined at baseline and then every six hours for the following 72 hours after randomization.
During the study period, conventional treatment was continued as per usual practice. Fluid challenges were performed, and repeated as necessary, to maintain central venous pressure (CVP) ≥8 and pulmonary arterial occlusion pressure (PAOP) ≥12 mmHg. Norepinephrine was titrated to maintain mean arterial pressure (MAP) ≥65 mmHg. Packed red blood cells were transfused when Hemoglobin (Hb) concentrations decreased below 7 g/dL, or if the patient exhibited clinical signs of inadequate systemic oxygen supply.
remifentanylDrug
Only the dose of remifentanyl (initial infusion of 6 µg/kg/h) can be changed to achieve a Goal of sedation: Richmond agitation-sedation scale 0 to -2.
| Study group | Role | What they receive |
|---|---|---|
| DEX group | Experimental | continuous infusion of Dexmedetomidine at 0.4 μg/kg per hour and remifentanyl A microdialysis probe was placed into the femoral quadriceps. An initial set of measurements will be obtained during the sedation with Midazolam and remifentanyl (before randomization). This set of measurements will be considered as baseline. Then samples were collected every 6 hours for 3 days. The changes in the energy-related metabolites lactate, the lactate/pyruvate ratio, glucose and glycerol were analyzed. Concomitantly with dialysate sampling, the effects on global haemodynamics, were assessed. Lactate and L/P clearances were also calculated. Receives: Device: Microdialysis Probe (Muscle microdialysis); Drug: remifentanyl |
| MDZ group | Active comparator | continuous infusion of a Midazolam at 0,1 mg/kg/h and remifentanyl A microdialysis probe was placed into the femoral quadriceps. An initial set of measurements will be obtained during the sedation with Midazolam and remifentanyl (before randomization). This set of measurements will be considered as baseline. Then samples were collected every 6 hours for 3 days. The changes in the energy-related metabolites lactate, the lactate/pyruvate ratio, glucose and glycerol were analyzed. Concomitantly with dialysate sampling, the effects on global haemodynamics, were assessed. Lactate and L/P clearances were also calculated. Receives: Device: Microdialysis Probe (Muscle microdialysis); Drug: remifentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the concentration of glucose(mmol/l) in the extracellular fluid of the skeletal muscle
collected every 6 hours for 3 days
Measured: Time Frame: At baseline and then every six hours for the following 72 hours after randomization
changes in the concentration of lactate(mmol/l) in the extracellular fluid of the skeletal muscle
collected every 6 hours for 3 days
Measured: Time Frame: At baseline and then every six hours for the following 72 hours after randomization
changes in the concentration of pyruvate (µmol/l) in the extracellular fluid of the skeletal muscle
collected every 6 hours for 3 days
Measured: Time Frame: At baseline and then every six hours for the following 72 hours after randomization
changes in the concentration of glycerol (µmol/l) in the extracellular fluid of the skeletal muscle
collected every 6 hours for 3 days
Measured: Time Frame: At baseline and then every six hours for the following 72 hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start8 Feb 2018
- Primary completion30 Nov 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Hospital of Tunis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajjej Zied, Military Hospital of Tunis
- Investigators
- Mustapha Ferjani, Study director, Department of C ritical C are Medicine and Anesthesiology, Military Hospital of Tunis, Tunisia, Tunis, Tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434691
- Sponsor's protocol ID
- DEX03/06
- Status last verified
- Feb 2018
- First submitted
- 8 Feb 2018
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients: a Muscle Microdialysis Study
- ClinicalTrials.gov ID
- NCT03434691
- Acronym / sponsor ID
- DEX03/06
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Military Hospital of TunisUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 15 Feb 2018 (actual)
- 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.
To investigate changes in the concentration of glucose, lactate, pyruvate and glycerol in the extracellular fluid of the skeletal muscle following Dexmedetomidine administration in patients with septic shock.
Detailed description
Prospective randomized double blinded study. Investigators planned to enroll 60 cases diagnosed with septic shock All patients will be sedated with Midazolam and remifentanyl in accordance with a local unit protocol.
After a period of six hours of hemodynamic stability, patients were randomized to receive either continuous infusion of Dexmedetomidine at 0.4 μg/kg per hour and remifentanyl (DEX group) or a continuous infusion of a Midazolam and remifentanyl (MDZ Group).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEX group | Experimental | Device: Microdialysis Probe (Muscle microdialysis), Drug: remifentanylcontinuous infusion of Dexmedetomidine at 0.4 μg/kg per hour and remifentanyl A microdialysis probe was placed into the femoral quadriceps. An initial set of measurements will be obtained during the sedation with Midazolam and remifentanyl (before randomization). This set of measurements will be considered as baseline. Then samples were collected every 6 hours for 3 days. The changes in the energy-related metabolites lactate, the lactate/pyruvate ratio, glucose and glycerol were analyzed. Concomitantly with dialysate sampling, the effects on global haemodynamics, were assessed. Lactate and L/P clearances were also calculated. |
| MDZ group | Active comparator | Device: Microdialysis Probe (Muscle microdialysis), Drug: remifentanylcontinuous infusion of a Midazolam at 0,1 mg/kg/h and remifentanyl A microdialysis probe was placed into the femoral quadriceps. An initial set of measurements will be obtained during the sedation with Midazolam and remifentanyl (before randomization). This set of measurements will be considered as baseline. Then samples were collected every 6 hours for 3 days. The changes in the energy-related metabolites lactate, the lactate/pyruvate ratio, glucose and glycerol were analyzed. Concomitantly with dialysate sampling, the effects on global haemodynamics, were assessed. Lactate and L/P clearances were also calculated. |
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 aged over 18 years
- Septic shock requiring norepinephrine (NE) to maintain a mean arterial pressure (MAP) of at least 65mm Hg despite appropriate volume resuscitation (fluid challenge of 20 mL/kg-40 mL/kg)
- Septic shock criteria were defined according to the new Sepsis-3 definition
Key exclusion criteria (12 listed)
- pregnancy
- uncontrolled hemorrhage
- terminal heart failure
- significant valvular heart disease
- documented or suspected acute coronary syndrome, and limitations on the use of inotropes: left ventricle outflow obstruction, systolic anterior motion of the mitral valve
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 |
|---|---|---|
| Microdialysis Probe (Muscle microdialysis)Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were determined at baseline and then every six hours for the following 72 hours after randomization. During the study period, conventional treatment was continued as per usual practice. Fluid challenges were performed, and repeated as necessary, to maintain central venous pressure (CVP) ≥8 and pulmonary arterial occlusion pressure (PAOP) ≥12 mmHg. Norepinephrine was titrated to maintain mean arterial pressure (MAP) ≥65 mmHg. Packed red blood cells were transfused when Hemoglobin (Hb) concentrations decreased below 7 g/dL, or if the patient exhibited clinical signs of inadequate systemic oxygen supply. | Device | DEX group, MDZ group |
| remifentanylOnly the dose of remifentanyl (initial infusion of 6 µg/kg/h) can be changed to achieve a Goal of sedation: Richmond agitation-sedation scale 0 to -2. | Drug | DEX group, MDZ group |
Primary outcome
changes in the concentration of glucose(mmol/l) in the extracellular fluid of the skeletal muscle
Time frame: Time Frame: At baseline and then every six hours for the following 72 hours after randomization
collected every 6 hours for 3 days
changes in the concentration of lactate(mmol/l) in the extracellular fluid of the skeletal muscle
Time frame: Time Frame: At baseline and then every six hours for the following 72 hours after randomization
collected every 6 hours for 3 days
changes in the concentration of pyruvate (µmol/l) in the extracellular fluid of the skeletal muscle
Time frame: Time Frame: At baseline and then every six hours for the following 72 hours after randomization
collected every 6 hours for 3 days
changes in the concentration of glycerol (µmol/l) in the extracellular fluid of the skeletal muscle
Time frame: Time Frame: At baseline and then every six hours for the following 72 hours after randomization
collected every 6 hours for 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Mustapha Ferjani study director
Department of C ritical C are Medicine and Anesthesiology, Military Hospital of Tunis, Tunisia, Tunis, Tunisia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microdialysis Probe (Muscle microdialysis) and remifentanyl in people with Septic Shock, run by Military Hospital of Tunis at 2 sites in Tunisia.
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 12 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: status not confirmed, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zied Hajjej (0021620358907, hajjej_zied@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in the concentration of glucose(mmol/l) in the extracellular fluid of the skeletal muscle (time frame: Time Frame: At baseline and then every six hours for the following 72 hours after randomization). The study lists 4 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 15 Feb 2018.