NCT02842437

Brief Summary

The purpose of this study is to assess the efficacy of dexmedetomidine on lung protection in patient with sepsis undergoing cleaning focus of infection.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 22, 2016

Status Verified

July 1, 2016

Enrollment Period

1.4 years

First QC Date

July 12, 2016

Last Update Submit

July 20, 2016

Conditions

Organ Protection

Keywords

dexmedetomidinesepsisrespiration

Outcome Measures

Primary Outcomes (6)

  • The Alveolar-Arterial Oxygen Difference

    Arterial blood samples were sampled before anesthesia for the alveolar-arterial oxygen difference by using blood gas analyzer.

    Before anesthesia

  • The Oxygenation Index

    Arterial blood samples were sampled before anesthesia for the oxygenation index by using blood gas analyzer.

    Before anesthesia

  • The Respiratory Index

    Arterial blood samples were sampled before anesthesia for the respiratory index by using blood gas analyzer.

    Before anesthesia

  • The Alveolar-Arterial Oxygen Difference

    Arterial blood samples were sampled at 3 minutes after the skin is sutured for the alveolar-arterial oxygen difference by using blood gas analyzer.

    At 3 minutes after the skin is sutured

  • The Oxygenation Index

    Arterial blood samples were sampled at 3 minutes after the skin is sutured for the oxygenation index by using blood gas analyzer.

    At 3 minutes after the skin is sutured

  • The Respiratory Index

    Arterial blood samples were sampled at 3 minutes after the skin is sutured for the respiratory index by using blood gas analyzer.

    At 3 minutes after the skin is sutured

Secondary Outcomes (3)

  • Change of tumor necrosis factor-α before anesthesia and after dexmedetomidine or placebo infusion instantly

    Before anesthesia and at 3 minutes after the skin is sutured

  • Change of interleukin-1β before anesthesia and after dexmedetomidine or placebo infusion instantly

    Before anesthesia and at 3 minutes after the skin is sutured

  • Change of the lactic acid before anesthesia and after dexmedetomidine or placebo infusion instantly

    Before anesthesia and at 3 minutes after the skin is sutured

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

25 patients receive a loading infusion of dexmedetomidine (1ug/kg) for 10min follow by a maintenance infusion (0.5ug/kg·h) continued until the end of the surgery

Drug: dexmedetomidine

Placebo

PLACEBO COMPARATOR

25 patients receive matching placebo （normal saline）

Other: normal saline

Interventions

dexmedetomidineDRUG

receive a loading infusion of dexmedetomidine (1ug/kg) for 10min follow by a maintenance infusion (0.5ug/kg·h) continued until the end of the surgery

Dexmedetomidine
normal salineOTHER

receive matching placebo (equal volume of normal saline)

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients with sepsis requiring abdominal cleaning focus of infection
  • older than 18 years
  • American Society of Anesthesiologists (ASA) physical status II-IV.

You may not qualify if:

  • Bradycardia
  • Atrioventricular block
  • Allergic to the drugs
  • A history of respiratory disease
  • Pregnancy or breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

MeSH Terms

Conditions

SepsisRespiratory Aspiration

Interventions

DexmedetomidineSaline Solution

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Zhang Yonghai

    General Hospital of Ningxia Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ma Hanxiang

CONTACT

+86-13519591508mahanxiang@hotmail.com

Zhang Yonghai

CONTACT

+86-15909508072zhangyongha@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 22, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 22, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)