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Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients

Primary Purpose

Septic Shock

Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Microdialysis Probe (Muscle microdialysis)
remifentanyl
Sponsored by
Military Hospital of Tunis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Military hospital of tunisRecruiting
  • Military Hopital of TunisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DEX group

MDZ group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

changes in the concentration of glucose(mmol/l) in the extracellular fluid of the skeletal muscle
collected every 6 hours for 3 days
changes in the concentration of lactate(mmol/l) in the extracellular fluid of the skeletal muscle
collected every 6 hours for 3 days
changes in the concentration of pyruvate (µmol/l) in the extracellular fluid of the skeletal muscle
collected every 6 hours for 3 days
changes in the concentration of glycerol (µmol/l) in the extracellular fluid of the skeletal muscle
collected every 6 hours for 3 days

Secondary Outcome Measures

Full Information

First Posted
February 8, 2018
Last Updated
February 13, 2018
Sponsor
Military Hospital of Tunis
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1. Study Identification

Unique Protocol Identification Number
NCT03434691
Brief Title
Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients
Official Title
Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients: a Muscle Microdialysis Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Military Hospital of Tunis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DEX group
Arm Type
Experimental
Arm Description
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.
Arm Title
MDZ group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Microdialysis Probe (Muscle microdialysis)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
remifentanyl
Intervention Description
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 Measure Information:
Title
changes in the concentration of glucose(mmol/l) in the extracellular fluid of the skeletal muscle
Description
collected every 6 hours for 3 days
Time Frame
Time Frame: At baseline and then every six hours for the following 72 hours after randomization
Title
changes in the concentration of lactate(mmol/l) in the extracellular fluid of the skeletal muscle
Description
collected every 6 hours for 3 days
Time Frame
Time Frame: At baseline and then every six hours for the following 72 hours after randomization
Title
changes in the concentration of pyruvate (µmol/l) in the extracellular fluid of the skeletal muscle
Description
collected every 6 hours for 3 days
Time Frame
Time Frame: At baseline and then every six hours for the following 72 hours after randomization
Title
changes in the concentration of glycerol (µmol/l) in the extracellular fluid of the skeletal muscle
Description
collected every 6 hours for 3 days
Time Frame
Time Frame: At baseline and then every six hours for the following 72 hours after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zied Hajjej
Phone
0021620358907
Email
hajjej_zied@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustapha Ferjani
Organizational Affiliation
Department of C ritical C are Medicine and Anesthesiology, Military Hospital of Tunis, Tunisia, Tunis, Tunisia
Official's Role
Study Director
Facility Information:
Facility Name
Military hospital of tunis
City
Tunis
State/Province
Mont Fleury
ZIP/Postal Code
1008
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zied hajjej, Dr
Phone
+21620358907
Email
hajjej_zied@hotmail.com
First Name & Middle Initial & Last Name & Degree
zied hajjej, dr
Facility Name
Military Hopital of Tunis
City
Tunis
ZIP/Postal Code
1008
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mustapha ferjani
Phone
98329256
Email
mustapha.ferjani@planet.tn
First Name & Middle Initial & Last Name & Degree
zied hajjej
Phone
20358907
Email
hajjej_zied@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients

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