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Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434691
Recruitment Status : Unknown
Verified February 2018 by Hajjej Zied, Military Hospital of Tunis.
Recruitment status was:  Recruiting
First Posted : February 15, 2018
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Hajjej Zied, Military Hospital of Tunis

Brief 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.

Condition or disease Intervention/treatment Phase
Septic Shock Device: Microdialysis Probe (Muscle microdialysis) Drug: remifentanyl Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients: a Muscle Microdialysis Study
Actual Study Start Date : February 8, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: DEX group
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.
Device: 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.


Drug: remifentanyl
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.

Active Comparator: MDZ group
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.
Device: 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.


Drug: remifentanyl
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434691


Contacts
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Contact: Zied Hajjej 0021620358907 hajjej_zied@hotmail.com

Locations
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Tunisia
Military hospital of tunis Recruiting
Tunis, Mont Fleury, Tunisia, 1008
Contact: zied hajjej, Dr    +21620358907    hajjej_zied@hotmail.com   
Principal Investigator: zied hajjej, dr         
Military Hopital of Tunis Recruiting
Tunis, Tunisia, 1008
Contact: mustapha ferjani    98329256    mustapha.ferjani@planet.tn   
Contact: zied hajjej    20358907    hajjej_zied@hotmail.com   
Sponsors and Collaborators
Military Hospital of Tunis
Investigators
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Study Director: Mustapha Ferjani Department of C ritical C are Medicine and Anesthesiology, Military Hospital of Tunis, Tunisia, Tunis, Tunisia
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Responsible Party: Hajjej Zied, Clinical Professor, Military Hospital of Tunis
ClinicalTrials.gov Identifier: NCT03434691    
Other Study ID Numbers: DEX03/06
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents