Dex on Microcirculation in SS-A Double-blinded Study

Southeast University, China

Status and phase: Unknown; Phase 4

Conditions: Septic Shock

Treatments: Drug: Dexmedetomidine for dexmedetomidine group

Study type: Interventional

Funder types: Other

Identifiers

NCT02612181

2015ZDSYLL016.1

Details and patient eligibility

About

The investigators preliminary study showed that dexmedetomidine might improve microcirculation in septic shock patients. To test this effect, the investigators will conduct double-blinded study.

Full description

Dexmedetomidine is a highly selective α2-adrenoreceptor agonist for sedation of adult critically ill patients which exhibits sedative and analgesic effects. Recent studies suggest that dexmedetomidine to restore adrenergic vasoconstrictor responsiveness in septic shock, and prevents alterations of pain rat model intestinal microcirculation Induced by surgical stress，even it can reduce the mortality of endotoxemic rats and patients with severe sepsis. The investigators preliminary study showed that dexmedetomidine might improve microcirculation in septic shock patients. To test this effect, the investigators will conduct double-blinded study.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Septic shock patients despite early goal directed therapy
• Agree to participate this study

Exclusion criteria

• Age< 18
• Pregnancy
• Bradycardia (HR<55bpm)
• Systolic Blood Pressure < 80 mmHg / Mean arterial pressure < 50 mmHg on maximal support
• Death imminent
• Unlikely to survive 90 days
• Acute liver failure
• Dementia
• High-grade block in the absence of a functioning pacemaker.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

Dexmedetomidine group

Experimental group

Description:

Dexmedetomidine group: Dexmedetomidine infusion for dexmedetomidine group to the goal of sedation: Richmond agitation-sedation scale 0 to -2 Dexmedetomidine doses 0-0.7 mcg/kg/h

Treatment:

Drug: Dexmedetomidine for dexmedetomidine group

Control group

Placebo Comparator group

Description:

Control group: Placebo infusion for control group to the goal of sedation: Richmond agitation-sedation scale 0 to -2 Control drug doses 0-0.7 mcg/kg/h

Treatment:

Drug: Dexmedetomidine for dexmedetomidine group