Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients

NCT03434691 | Unknown DMC

• 1 other identifier: DEX03/06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

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.

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.

Device: Microdialysis Probe (Muscle microdialysis); Drug: remifentanyl

Interventions

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.

DEX group; MDZ group

remifentanyl DRUG

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.

DEX group; MDZ group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• nd 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

Sponsors & Collaborators

• Military Hospital of Tunis: lead

Study Sites (2)

Military hospital of tunis

Tunis, Mont Fleury, 1008, Tunisia

RECRUITING

Military Hopital of Tunis

Tunis, 1008, Tunisia

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mustapha Ferjani

  Department of C ritical C are Medicine and Anesthesiology, Military Hospital of Tunis, Tunisia, Tunis, Tunisia

  STUDY DIRECTOR

Central Study Contacts

Zied Hajjej

CONTACT

0021620358907; hajjej_zied@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 15, 2018
• Study Start: February 8, 2018
• Primary Completion: November 30, 2018
• Study Completion: December 31, 2018
• Last Updated: February 15, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)