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Early Goal Directed Sedation on Microcirculation in Septic Shock

The Effect of Early Goal Directed Sedation on Microcirculation in Septic Shock Patients With Mechanical Ventilation

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02612363
Enrollment
25
Registered
2015-11-23
Start date
2015-11-30
Completion date
2016-12-31
Last updated
2016-04-20

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

Conditions

Septic Shock

Keywords

septic shock, sedation, microcirculation

Brief summary

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.

Detailed 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.

Interventions

DRUGDexmedetomidine for sedation

Dexmedetomidine or control drug for sedation * Analgesia * Propofol at lowest dosage. * Dose range: 0.1- 0.7 u/kg/hour * Target RASS score of -2 to +1 * Supplemental other sedatives at lowest effective dose

Sponsors

Southeast University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Microcirculatory function as assessed by perfused vessel densityone hourMicrocirculatory parameter

Secondary

MeasureTime frame
Dose of sedatives and analgesic agents14 days
Oxygen metabolic: lactate clearance timesix hours

Countries

China

Contacts

Primary ContactJingyuan Xu, M.D.
xujingyuanmail@163.com0086-025-83262550

Outcome results

None listed

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