Trial Outcomes & Findings for the Effect of Dopamine on Mechanical Ventilation Induced Lung Injury (NCT NCT03317431)

NCT ID: NCT03317431

Last Updated: 2018-10-22

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 46 participants
• Primary outcome timeframe: 20min-60min
• Results posted on: 2018-10-22

Participant Flow

Participant milestones

Measure	Ventilation 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 Study STARTED	46
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

the Effect of Dopamine on Mechanical Ventilation Induced Lung Injury

Baseline characteristics by cohort

Measure	Ventilation n=46 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	46 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment China	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 20min-60min

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.

Outcome measures

Measure	Ventilation n=46 Participants 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.
Correlation Coefficient (r) Between Duration of Mechanical Ventilation and DRD1 Expression	-0.555 pearson Correlation Coefficient

SECONDARY outcome

Timeframe: 20min-60min

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.

Outcome measures

Measure	Ventilation n=46 Participants 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.
Correlation Coefficient (r) Between Duration of Mechanical Ventilation and DRD2 Expression	0.094 pearson Correlation coefficient

SECONDARY outcome

Timeframe: 20min-60min

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.

Outcome measures

Measure	Ventilation n=46 Participants 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.
the Expression of TH in Lung Tissues	-0.047 pearson correlation coefficient

SECONDARY outcome

Timeframe: 20min-60min

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.

Outcome measures

Measure	Ventilation n=46 Participants 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.
the Expression of DDC in Lung Tissues	-0.012 pearson correlation coefficient

SECONDARY outcome

Timeframe: 20min-60min

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.

Outcome measures

Measure	Ventilation n=46 Participants 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.
the Expression of Ac-a-tubulin in Lung Tissues	-0.465 pearson correlation coefficient

Adverse Events

Ventilation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Lai Jiang

Department of Anesthesia,Xinhua hospital affiliated to Shanghai Jiaotong University School of Medicine

Phone: 021-25078999

Email: jianglaimz@sina.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place