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

The Effect of Dexmedetomidine on Perfusion Index and Microcirculation in Patients With Severe Sepsis and Septic Shock: Randomized Controlled Study

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03151668

Enrollment

Registered

2017-05-12

Start date

2017-01-04

Completion date

2018-04-30

Last updated

2018-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Brief summary

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.

Detailed 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.

Interventions

DRUGDexmedetomidine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Evaluation of microvascular flow index 6hours after dexmedetomidine infusion	6 months

Secondary

Measure	Time frame
The effect of the dexmeditomidine on perfusion index	6 months
Correlation between perfusion index and microvascular flow index in septic shock patients	6 months

Countries

Egypt

Contacts

Primary ContactIslam R Abd el-fttah

Islam_rasmy158@yahoo.com+201002024166

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026