Early Goal Directed Sedation on Microcirculation in Septic Shock

NCT02612363 | Unknown Phase 4 DMC

• 1 other identifier: 2015ZDSYLL016.0
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

septic shock; sedation; microcirculation

Outcome Measures

Primary Outcomes (1)

• Microcirculatory function as assessed by perfused vessel density

  Microcirculatory parameter

  one hour

Secondary Outcomes (2)

• Dose of sedatives and analgesic agents

  14 days

• Oxygen metabolic: lactate clearance time

  six hours

Study Arms (2)

Early goal directed sedation group

EXPERIMENTAL

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

Drug: Dexmedetomidine for sedation

Standard sedation

PLACEBO COMPARATOR

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

Drug: Dexmedetomidine for sedation

Interventions

Dexmedetomidine for sedation DRUG

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

Also known as: Control drug for sedation

Early goal directed sedation group; Standard sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Interventions

Dexmedetomidine; Drug and Narcotic Control

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Legislation, Drug; Legislation as Topic; Social Control, Formal; Health Care Economics and Organizations; Pharmacy Administration; Organization and Administration; Health Services Administration

Study Officials

• Yi Yang, Ph.D.

  Southeast University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingyuan Xu, M.D.

CONTACT

0086-025-83262550; xujingyuanmail@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: November 23, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

CN (1)