Effects of Dexmedetomidine vs Midazolam on Microcirculation in Septic Shock Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-08

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Renal Protection Of Dexmedetomidine Versus Midazolam As a Sedative For Septic Patients In Intensive Care Unit

NCT05903963

Renal Failure

UNKNOWN PHASE1

Dexmedetomidine Versus Midazolam for Continuous Sedation in the Intensive Care Unit (ICU)

NCT00481312

Continuous Sedation in Initially Sedated Adults in ICU

COMPLETED PHASE3

The Effect of Dexmedetomidine on Microcirculation in Severe Sepsis

NCT02109965

Severe Sepsis

TERMINATED PHASE4

Dexmedetomidine in Modifying Immune Paralysis In Patient With Septic Shock

NCT03989609

Septic Shock

COMPLETED PHASE2

Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia

NCT02141412

Anesthesia Recovery Anesthesia Emergence Shivering +1 more

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Septic Shock

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Microdialysis Probe (Muscle microdialysis)

Intervention Type 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.

remifentanyl

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Microdialysis Probe (Muscle microdialysis)

Intervention Type 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.

remifentanyl

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No