NCT03317431

Brief Summary

Dopamine(DA) is a common neurotransmitter that has been known to regulate behavior, movement, cardiovascular,endocrine and gastrointestinal functions, but also functions as an important molecule engaging in the immune systems to possess anti-inflammatory effects. However, its role in ventilator-induced lung injury (VILI) is still unclear. Herein, this study aimed to investigate the therapeutic efficacy of dopamine on ventilation-induced lung endothelial barrier dysfunction and explore the possible underlying molecular mechanisms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 20, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 22, 2018

Completed
Last Updated

October 22, 2018

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

July 17, 2017

Results QC Date

October 22, 2017

Last Update Submit

December 27, 2017

Conditions

Keywords

dopamine,mechanical ventilation,lung injury

Outcome Measures

Primary Outcomes (1)

  • Correlation Coefficient (r) Between Duration of Mechanical Ventilation and DRD1 Expression

    ImageJ software were used to get the Integrated Optical Density(IOD) of the chemiluminescent signal from the membranes of dopamine receptor 1(DRD1). The normalization was carried out by DRD1 IOD/total β-actin IOD for sample loading correction. In determination of the expression level of DRD1 in different time points, the investigators had a bulk preparation of normal placental protein which was set as a control. Analyze the correlation between duration of mechanical ventilation and DRD1 expression. If p value is less than 0.05, then its change is statically significant.

    20min-60min

Secondary Outcomes (4)

  • Correlation Coefficient (r) Between Duration of Mechanical Ventilation and DRD2 Expression

    20min-60min

  • the Expression of TH in Lung Tissues

    20min-60min

  • the Expression of DDC in Lung Tissues

    20min-60min

  • the Expression of Ac-a-tubulin in Lung Tissues

    20min-60min

Study Arms (1)

ventilation

patients undergoing selective operation with general anesthesia(GA) and mechanical ventilation(MV)

Other: mechanical ventilation

Interventions

mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cmH2O, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5.

ventilation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients undergo elective lobectom

You may not qualify if:

  • Distant metastases: recent anaesthetics or mechanical ventilation treatment;children;women during pregnancy or lactation; being involved in other clinical subjects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia, Shanghai Xinhua hospital

Shanghai, Shanghai Municipality, 200082, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gather the lung tissues from patients undergo lobectomy with general anesthesia and mechanical ventilation

MeSH Terms

Conditions

Acute Lung Injury

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Results Point of Contact

Title
Dr.Lai Jiang
Organization
Department of Anesthesia,Xinhua hospital affiliated to Shanghai Jiaotong University School of Medicine

Study Officials

  • Lai Jiang, chief doctor

    Xinhua Hospital affiliated to Medicine school,Shanghai Jiaotong University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2017

First Posted

October 23, 2017

Study Start

March 20, 2017

Primary Completion

October 22, 2017

Study Completion

December 1, 2017

Last Updated

October 22, 2018

Results First Posted

October 22, 2018

Record last verified: 2017-03

Locations