Early Goal Directed Sedation on Microcirculation in Septic Shock

S

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

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

Trial contacts and locations

1

Loading...

Central trial contact

Jingyuan Xu, M.D.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems