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the Effect of Dopamine on Mechanical Ventilation Induced Lung Injury

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ClinicalTrials.gov Identifier: NCT03317431
Recruitment Status : Completed
First Posted : October 23, 2017
Results First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Acute Lung Injury
Intervention Other: mechanical ventilation
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ventilation
Hide Arm/Group Description

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

mechanical ventilation: 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.

Period Title: Overall Study
Started 46
Completed 46
Not Completed 0
Arm/Group Title Ventilation
Hide Arm/Group Description

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

mechanical ventilation: 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.

Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
<=18 years
0
   0.0%
Between 18 and 65 years
46
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
13
  28.3%
Male
33
  71.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
American Indian or Alaska Native
0
   0.0%
Asian
46
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 46 participants
46
1.Primary Outcome
Title Correlation Coefficient (r) Between Duration of Mechanical Ventilation and DRD1 Expression
Hide Description 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.
Time Frame 20min-60min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ventilation
Hide Arm/Group Description:

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

mechanical ventilation: 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.

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: pearson Correlation Coefficient
-0.555
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ventilation
Comments Analysis the relationship between the duration of mechanical ventilation with DRD1 expression.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
2.Secondary Outcome
Title Correlation Coefficient (r) Between Duration of Mechanical Ventilation and DRD2 Expression
Hide Description ImageJ software were used to get the Integrated Optical Density(IOD) of the chemiluminescent signal from the membranes of dopamine receptor 2(DRD2). The normalization was carried out by DRD2 IOD/total β-actin IOD for sample loading correction. In determination of the expression level of DRD2 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 DRD2 expression. If p value is less than 0.05, then its change is statically significant.
Time Frame 20min-60min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ventilation
Hide Arm/Group Description:

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

mechanical ventilation: 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.

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: pearson Correlation coefficient
0.094
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ventilation
Comments Analysis the relationship between the duration of mechanical ventilation with DRD2 expression.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.01
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
3.Secondary Outcome
Title the Expression of TH in Lung Tissues
Hide Description ImageJ software were used to get the Integrated Optical Density(IOD) of the chemiluminescent signal from the membranes of Tyrosine hydroxylase(TH). The normalization was carried out by TH IOD/total β-actin IOD for sample loading correction. In determination of the expression level of TH 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 TH expression. If p value is less than 0.05, then its change is statically significant.
Time Frame 20min-60min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ventilation
Hide Arm/Group Description:

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

mechanical ventilation: 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.

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: pearson correlation coefficient
-0.047
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ventilation
Comments Analysis the relationship between the duration of mechanical ventilation with TH expression.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.01
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
4.Secondary Outcome
Title the Expression of DDC in Lung Tissues
Hide Description ImageJ software were used to get the Integrated Optical Density(IOD) of the chemiluminescent signal from the membranes of Dopa decarboxylase(DDC). The normalization was carried out by DDC IOD/total β-actin IOD for sample loading correction. In determination of the expression level of DDC 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 DDC expression. If p value is less than 0.05, then its change is statically significant.
Time Frame 20min-60min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ventilation
Hide Arm/Group Description:

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

mechanical ventilation: 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.

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: pearson correlation coefficient
-0.012
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ventilation
Comments Analysis the relationship between the duration of mechanical ventilation with DDC expression.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.01
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
5.Secondary Outcome
Title the Expression of Ac-a-tubulin in Lung Tissues
Hide Description ImageJ software were used to get the Integrated Optical Density(IOD) of the chemiluminescent signal from the membranes of acetylated-a-tubulin(Ac-a-tubulin). The normalization was carried out by Ac-a-tubulin IOD/total β-actin IOD for sample loading correction. In determination of the expression level of Ac-a-tubulin 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 Ac-a-tubulin expression. If p value is less than 0.05, then its change is statically significant.
Time Frame 20min-60min
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ventilation
Hide Arm/Group Description:

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

mechanical ventilation: 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.

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: pearson correlation coefficient
-0.465
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ventilation
Comments Analysis the relationship between the duration of mechanical ventilation with Ac-a-tubulin expression.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Time Frame 20-60 min
Adverse Event Reporting Description All-Cause Mortality, Serious, and Other Adverse Events were not monitored/assessed.Because the investigators gain the lung tissue from the pathology department after the surgery.
 
Arm/Group Title Ventilation
Hide Arm/Group Description

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

mechanical ventilation: 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.

All-Cause Mortality
Ventilation
Affected / at Risk (%)
Total   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Ventilation
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ventilation
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr.Lai Jiang
Organization: Department of Anesthesia,Xinhua hospital affiliated to Shanghai Jiaotong University School of Medicine
Phone: 021-25078999
Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03317431     History of Changes
Other Study ID Numbers: XH-17-011
First Submitted: July 17, 2017
First Posted: October 23, 2017
Results First Submitted: October 22, 2017
Results First Posted: October 22, 2018
Last Update Posted: October 22, 2018