Septic Shock
Conditions
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).
Interventions
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.
DRUGremifentanyl
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.
Sponsors
Military Hospital of Tunis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in the concentration of glucose(mmol/l) in the extracellular fluid of the skeletal muscle | 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: 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: 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: At baseline and then every six hours for the following 72 hours after randomization | collected every 6 hours for 3 days |
Countries
Tunisia
Contacts
Primary ContactZied Hajjej
Outcome results
None listed