Dex on Microcirculation in SS-A Double-blinded Study

S

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

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

Trial contacts and locations

1

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Central trial contact

Jingyuan Xu, M.D.

Data sourced from clinicaltrials.gov

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