Early Goal Directed Sedation on Microcirculation in Septic Shock

Southeast University, China

Status and phase: Unknown; Phase 4

Conditions: Septic Shock

Treatments: Drug: Dexmedetomidine for sedation

Study type: Interventional

Funder types: Other

Identifiers

NCT02612363

2015ZDSYLL016.0

Details and patient eligibility

About

The investigators will conduct a prospective, single-center, randomized, double-blinded, controlled study to investigate the effect of early goal directed sedation on microcirculation in early septic shock patients.

Full description

Recent studies suggest that early goal directed sedation might improve the outcome of critically ill patients. The investigators will conduct a prospective, single-center, randomized, double-blinded, controlled study to investigate the effect of early goal directed sedation on microcirculation in early septic shock patients with relative stable hemodynamics.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Septic shock patients despite early goal directed therapy
• Required sedation

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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25 participants in 2 patient groups, including a placebo group

Early goal directed sedation group

Experimental group

Description:

Dexmedetomidine for sedation in early goal directed sedation group * Analgesia * Dexmedetomidine start at 0.7ug/kg/hour * Dose range: 0.2- 0.7 u/kg/hour * Supplemental other sedatives at lowest effective dose Target Richmond Agitation-Sedation Scale score of -2 to +1 to achieve sedation goal in EGDS group

Treatment:

Drug: Dexmedetomidine for sedation

Standard sedation

Placebo Comparator group

Description:

Control drug for sedation in early goal directed sedation group * Analgesia * Control drug * Supplemental other sedatives at lowest effective dose for standard sedation Target Richmond Agitation-Sedation Scale score of -2 to +1 to achieve sedation goal

Treatment:

Drug: Dexmedetomidine for sedation