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Effect of Dexmedetomidine on Perfusion Index and Microcirculation in Severe Sepsis and Septic Shock Patients

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Unknown
Phase 3

Conditions

Septic Shock

Treatments

Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT03151668
N-14 -2017

Details and patient eligibility

About

Septic shock is one of the major causes of death worldwide with in-hospital mortality rates varying between (11.9% to 47.2 %). Alterations in microcirculatory blood flow were associated with high risk of organ dysfunction and death. Experimental studies on septic rats revealed that dexmedetomidine treatment can effectively reduce the generation of inflammatory mediators and yields beneficial effects on endotoxemic animals' microcirculation.

Full description

Prospective randomized double blinded study. Investigators planned to enroll (40 cases diagnosed with severe sepsis and/or septic shock ) admitted in 50-bed trauma and surgical ICU Cairo University hospital. Demographic data, cause of ICU admission, source of sepsis, APACHE II score, SOFA score 24 hours after admission. Microcirculatory variables (MFI), peripheral perfusion (PI) and metabolic variables will be measured before drugs administrations and at 2, 4, 6, 24 hours thereafter. The total dose of the infused drugs, The requirement of vasopressor will be evaluated as yes/no and total dose of vasopressor will be calculated.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age more than 18 years old
  • All mechanically ventilated patients who will be clinically suspected of having severe sepsis/septic shock defined by the criteria of the American College of Chest Physicians/ Society of Critical Care Medicine Consensus Conference

Exclusion criteria

  • Age < 18 years old
  • Pregnant patient
  • Acute hepatitis or severe liver disease (Child-Pugh class C)
  • Left ventricular ejection fraction less than 30%
  • Heart rate less than 50 beats/min
  • Second or third degree heart block
  • Systolic pressure < 90 mmHg despite of infusion of 2 vasopressors

Trial design

40 participants in 2 patient groups

Dexmedetomidin
Experimental group
Treatment:
Drug: Dexmedetomidine
Midazolam
No Intervention group

Trial contacts and locations

1

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Central trial contact

Islam R Abd el-fttah

Data sourced from clinicaltrials.gov

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