Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients

Septic Shock Clinical Trial

Official title:

Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients: a Muscle Microdialysis Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03434691
• Other study ID #: DEX03/06
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2018
• Last updated: February 13, 2018
• Start date: February 8, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2018
• Source: Military Hospital of Tunis
• Contact: Zied Hajjej
• Phone: 0021620358907
• Email: hajjej_zied[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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.

Locations

Country	Name	City	State
Tunisia	Military Hopital of Tunis	Tunis
Tunisia	Military hospital of tunis	Tunis	Mont Fleury

Sponsors (1)

Lead Sponsor	Collaborator
Military Hospital of Tunis

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in the concentration of glucose(mmol/l) in the extracellular fluid of the skeletal muscle	collected every 6 hours for 3 days	Time Frame: At baseline and then every six hours for the following 72 hours after randomization
Primary	changes in the concentration of lactate(mmol/l) in the extracellular fluid of the skeletal muscle	collected every 6 hours for 3 days	Time Frame: At baseline and then every six hours for the following 72 hours after randomization
Primary	changes in the concentration of pyruvate (µmol/l) in the extracellular fluid of the skeletal muscle	collected every 6 hours for 3 days	Time Frame: At baseline and then every six hours for the following 72 hours after randomization
Primary	changes in the concentration of glycerol (µmol/l) in the extracellular fluid of the skeletal muscle	collected every 6 hours for 3 days	Time Frame: At baseline and then every six hours for the following 72 hours after randomization