Acute Lung Injury
Conditions
Keywords
mechanical ventilation, echocardiography, right ventricular function, Ang (1-7), Ang II, Renin-angiotensin system
Brief summary
The purpose of this study is to assess whether circulating Angiotensin (Ang) II and Ang (1-7) levels are associated with right ventricular (RV) dysfunction in mechanically ventilated subjects. It is also designed to further characterize the subject population for severity of RV dysfunction. This study will investigate the association of renin-angiotensin system (RAS) peptides and markers of RV function, as measured by echocardiography, in subjects requiring acute mechanical ventilation. Maximum 150 subjects will be enrolled for the study and they will be evaluated over three days period using standard of care investigations, including trans-thoracic echocardiography (TTE) and/or trans-esophageal echocardiography (TOE) echocardiography. The maximum total duration of this study for subjects is 28 days.
Interventions
Local standard of care will include fluid resuscitation, use of vasopressor drugs and renal support.
PROCEDUREMechanical ventilation
Mechanical ventilation will be based on volume-assist control mode, with a target tidal volume of 6-8 milliliter per kg (mL/kg) and a target plateau pressure of 30 centimeter of water (cmH2O).
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subject must be 18 to 80 years of age inclusive, at the time of enrolment. * Subjects who are receiving invasive mechanical ventilation (duration of ventilation less than equal to 48 hours). * Body mass index within the range 18.0 - 38.0 kilograms per meter square (kg/m\^2, inclusive). Clinical estimate of height and weight is acceptable. * Given subjects will be mechanically ventilated upon enrolment, obtaining informed consent directly from the subjects will not be feasible. Consent will be obtained by subject's Legally Acceptable Representative (LAR) or subject will be enrolled upon emergency consent process or subject will be enrolled by signing the informed consent.
Exclusion criteria
* Subjects who are moribund or whose clinical condition is deteriorating rapidly or any subject for whom the investigator does not consider there is a reasonable expectation that they will be able to complete the 3 days of observation in the study. * Subjects undergoing elective surgery. Investigator will make every effort to ensure that the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renin-angiotensin System Cascade Biomarker to Include Angiotensin (Ang) II Level | Days 1, 2 and 3 | Blood samples were collected for renin-angiotensin system biomarkers at indicated time points. Evaluable Population consisted of all participants for whom pulmonary arterial systolic pressure (PASP), ratio of right ventricular to left ventricular end-diastolic area (RV size ratio), Ang II and Ang(1-7) data have been recorded for at least one study time point, and who did not retrospectively withdraw the consent. |
| Ratio of RV to Left Ventricular (LV) End-diastolic Area (RV Size Ratio) | Days 1, 2 and 3 | Right ventricular size ratio was measured using TTE or TOE. |
| Number of Participants With Paradoxical Septal Motion | Days 1, 2 and 3 | Paradoxical septal motion is the systolic movement of the interventricular septum toward the RV despite normal thickening. Paradoxical septal motion was measured by TTE or TOE. Number of participants who had paradoxical septal motion have been reported. |
| Pulmonary Arterial Systolic Pressure at Indicated Time Points | Days 1, 2 and 3 | Pulmonary arterial systolic pressure was measured using TTE or TOE. |
| Right Atrial Pressure at Indicated Time Points | Days 1, 2 and 3 | Right atrial pressure is the blood pressure in the right atrium of the heart. Right atrial pressure was measured by TTE or TOE. |
| Inferior Vena Cava Diameter at End Expiration at Indicated Time Points | Days 1, 2 and 3 | Inferior vena cava diameter was measured using TTE or TOE. Pulmonary arterial systolic pressure was estimated from trans-tricuspid pressure and right atrial pressure or inferior vena cava diameter. |
| Pearson Correlation Coefficient Between PASP and Ang II Level | Up to Day 3 | Pearson correlation coefficient between PASP and Ang II level was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using Statistical Analysis Software (SAS). |
| Pearson Correlation Coefficient Between RV Size Ratio and Ang II Level | Up to Day 3 | Pearson correlation coefficient between RV size ratio and Ang II level was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pulmonary Circulatory Dysfunction | Days 1, 2 and 3 | Pulmonary circulatory dysfunction is defined as moderate dysfunction (pulmonary arterial systolic pressure \[\>40 millimeters of mercury\] or a dilated RV end diastolic RV/left ventricle \[LV\] area ratio \[\>=0.6\] but without septal dyskinesia). At risk Population consisted of participants who satisfied following criteria: 1. pulmonary arterial systolic pressure and ratio of RV to LV end-diastolic area recorded for all three study days \[regardless of the Ang II and Ang(1-7) status\] and/or; 2. databased acute cor pulmonale/pulmonary circulatory dysfunction and/or acute respiratory distress syndrome (ARDS) assessment during the study period (even if they do not have three days worth of study assessments for the echo outcomes) were evaluated for acute cor pulmonale/pulmonary circulatory dysfunction and ARDS incidence rates. Number of participants with Pulmonary Circulatory Dysfunction have been reported. |
| Number of Participants With Acute Cor Pulmonale | Days 1, 2 and 3 | Acute cor pulmonale is defined as a dilated RV in the mid-esophagus longitudinal view or apical 4-chamber view (end-diastolic RV/LV area ratio \[0.6\]) associated with the presence of a septal dyskinesia in the (transgastric) short-axis view of the heart. Number of participants with acute cor pulmonale have been reported. |
| Number of Participants With Severe Acute Cor Pulmonale | Days 1, 2 and 3 | Severe acute cor pulmonale is defined as severely dilated RV (end-diastolic RV/LV area ratio \>=1) with septal dyskinesia. Number of participants with severe acute cor pulmonale have been reported. |
| Renin-angiotensin System Cascade Biomarker: Ang(1-7) Level | Days 1, 2 and 3 | Blood samples were collected for renin-angiotensin system biomarkers at indicated time points. |
| Renin-angiotensin System Cascade Biomarker: Ang II/ Ang(1-7) Ratio | Days 1, 2 and 3 | Blood samples were collected for renin-angiotensin system biomarkers at indicated time points. |
| Pearson Correlation Coefficient Between PASP and Ang(1-7) | Up to Day 3 | Pearson correlation coefficient between PASP and Ang(1-7) was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS. |
| Pearson Correlation Coefficient Between PASP and Ang II/Ang(1-7) | Up to Day 3 | Pearson correlation coefficient between PASP and Ang II/Ang(1-7) was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS. |
| Pearson Correlation Coefficient Between RV Size Ratio and Ang(1-7) | Up to Day 3 | Pearson correlation coefficient between RV size ratio and Ang(1-7) was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS. |
| Pearson Correlation Coefficient Between RV Size Ratio and Ang II/Ang(1-7) | Up to Day 3 | Pearson correlation coefficient between RV size ratio and Ang II/Ang(1-7) was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS. |
Countries
France
Participant flow
Recruitment details
This study elucidated the association of the Renin-angiotensin system and right ventricular (RV) function in mechanically ventilated participants. This study was conducted at two centers in France from 11-June-2018 to 08-July-2019. A total of 57 participants were enrolled in this study.
Pre-assignment details
The study was terminated as overall probability of project success was considered low. The study had significant programmatic risks identified with development plan for Recombinant Human Angiotensin Converting Enzyme2 in critical care including participant identification, uncertainty around potential to impact mortality and operational feasibility.
Participants by arm
| Arm | Count |
|---|---|
| Mechanically Ventilated Participants Participants were enrolled following being mechanically ventilated and had their first echocardiogram (TTE and TOE) within 48 hours of mechanical ventilation. Participants were assessed every 24 hours for a further two days with daily echocardiography to monitor right and left ventricular function. Participants received standard of care including fluid, use of vasopressor drugs and renal support. | 57 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Mechanically Ventilated Participants | — |
|---|---|---|
| Age, Continuous | 63.74 Years STANDARD_DEVIATION 12.807 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 57 Participants | — |
| Sex: Female, Male Female | 24 Participants | — |
| Sex: Female, Male Male | 33 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 57 |
| other Total, other adverse events | 0 / 57 |
| serious Total, serious adverse events | 0 / 57 |
Outcome results
Primary
Inferior Vena Cava Diameter at End Expiration at Indicated Time Points
Inferior vena cava diameter was measured using TTE or TOE. Pulmonary arterial systolic pressure was estimated from trans-tricuspid pressure and right atrial pressure or inferior vena cava diameter.
Time frame: Days 1, 2 and 3
Population: Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mechanically Ventilated Participants | Inferior Vena Cava Diameter at End Expiration at Indicated Time Points | Day 1, n=38 | 18.529 Millimeter | Standard Deviation 4.894 |
| Mechanically Ventilated Participants | Inferior Vena Cava Diameter at End Expiration at Indicated Time Points | Day 2, n=41 | 18.412 Millimeter | Standard Deviation 5.5483 |
| Mechanically Ventilated Participants | Inferior Vena Cava Diameter at End Expiration at Indicated Time Points | Day 3, n=34 | 17.915 Millimeter | Standard Deviation 5.0126 |
Primary
Number of Participants With Paradoxical Septal Motion
Paradoxical septal motion is the systolic movement of the interventricular septum toward the RV despite normal thickening. Paradoxical septal motion was measured by TTE or TOE. Number of participants who had paradoxical septal motion have been reported.
Time frame: Days 1, 2 and 3
Population: Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mechanically Ventilated Participants | Number of Participants With Paradoxical Septal Motion | Day 1, n=43 | 5 Participants |
| Mechanically Ventilated Participants | Number of Participants With Paradoxical Septal Motion | Day 2, n=41 | 11 Participants |
| Mechanically Ventilated Participants | Number of Participants With Paradoxical Septal Motion | Day 3, n=34 | 10 Participants |
Primary
Pearson Correlation Coefficient Between PASP and Ang II Level
Pearson correlation coefficient between PASP and Ang II level was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using Statistical Analysis Software (SAS).
Time frame: Up to Day 3
Population: Evaluable Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mechanically Ventilated Participants | Pearson Correlation Coefficient Between PASP and Ang II Level | -0.019 Unitless |
Primary
Pearson Correlation Coefficient Between RV Size Ratio and Ang II Level
Pearson correlation coefficient between RV size ratio and Ang II level was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS.
Time frame: Up to Day 3
Population: Evaluable Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mechanically Ventilated Participants | Pearson Correlation Coefficient Between RV Size Ratio and Ang II Level | 0.153 Unitless |
Primary
Pulmonary Arterial Systolic Pressure at Indicated Time Points
Pulmonary arterial systolic pressure was measured using TTE or TOE.
Time frame: Days 1, 2 and 3
Population: Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mechanically Ventilated Participants | Pulmonary Arterial Systolic Pressure at Indicated Time Points | Day 1, n=38 | 36.350 Millimeters of mercury | Standard Deviation 15.707 |
| Mechanically Ventilated Participants | Pulmonary Arterial Systolic Pressure at Indicated Time Points | Day 2, n=39 | 35.564 Millimeters of mercury | Standard Deviation 12.2985 |
| Mechanically Ventilated Participants | Pulmonary Arterial Systolic Pressure at Indicated Time Points | Day 3, n=29 | 37.224 Millimeters of mercury | Standard Deviation 13.3521 |
Primary
Ratio of RV to Left Ventricular (LV) End-diastolic Area (RV Size Ratio)
Right ventricular size ratio was measured using TTE or TOE.
Time frame: Days 1, 2 and 3
Population: Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mechanically Ventilated Participants | Ratio of RV to Left Ventricular (LV) End-diastolic Area (RV Size Ratio) | Day 1, n=45 | 0.653 Ratio | Standard Deviation 0.2418 |
| Mechanically Ventilated Participants | Ratio of RV to Left Ventricular (LV) End-diastolic Area (RV Size Ratio) | Day 2, n=42 | 0.655 Ratio | Standard Deviation 0.2276 |
| Mechanically Ventilated Participants | Ratio of RV to Left Ventricular (LV) End-diastolic Area (RV Size Ratio) | Day 3, n=35 | 0.634 Ratio | Standard Deviation 0.1662 |
Primary
Renin-angiotensin System Cascade Biomarker to Include Angiotensin (Ang) II Level
Blood samples were collected for renin-angiotensin system biomarkers at indicated time points. Evaluable Population consisted of all participants for whom pulmonary arterial systolic pressure (PASP), ratio of right ventricular to left ventricular end-diastolic area (RV size ratio), Ang II and Ang(1-7) data have been recorded for at least one study time point, and who did not retrospectively withdraw the consent.
Time frame: Days 1, 2 and 3
Population: Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mechanically Ventilated Participants | Renin-angiotensin System Cascade Biomarker to Include Angiotensin (Ang) II Level | Day 1, n=44 | 41.693 Picograms per milliliter | Standard Deviation 67.4893 |
| Mechanically Ventilated Participants | Renin-angiotensin System Cascade Biomarker to Include Angiotensin (Ang) II Level | Day 2, n=43 | 43.861 Picograms per milliliter | Standard Deviation 110.6191 |
| Mechanically Ventilated Participants | Renin-angiotensin System Cascade Biomarker to Include Angiotensin (Ang) II Level | Day 3, n=35 | 27.801 Picograms per milliliter | Standard Deviation 49.1054 |
Primary
Right Atrial Pressure at Indicated Time Points
Right atrial pressure is the blood pressure in the right atrium of the heart. Right atrial pressure was measured by TTE or TOE.
Time frame: Days 1, 2 and 3
Population: Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mechanically Ventilated Participants | Right Atrial Pressure at Indicated Time Points | Day 1, n=42 | 9.055 Millimeters of mercury | Standard Deviation 4.5279 |
| Mechanically Ventilated Participants | Right Atrial Pressure at Indicated Time Points | Day 2, n=40 | 9.425 Millimeters of mercury | Standard Deviation 5.053 |
| Mechanically Ventilated Participants | Right Atrial Pressure at Indicated Time Points | Day 3, n=34 | 9.456 Millimeters of mercury | Standard Deviation 4.7456 |
Secondary
Number of Participants With Acute Cor Pulmonale
Acute cor pulmonale is defined as a dilated RV in the mid-esophagus longitudinal view or apical 4-chamber view (end-diastolic RV/LV area ratio \[0.6\]) associated with the presence of a septal dyskinesia in the (transgastric) short-axis view of the heart. Number of participants with acute cor pulmonale have been reported.
Time frame: Days 1, 2 and 3
Population: At risk Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mechanically Ventilated Participants | Number of Participants With Acute Cor Pulmonale | Day 1, n=56 | 5 Participants |
| Mechanically Ventilated Participants | Number of Participants With Acute Cor Pulmonale | Day 2, n=52 | 10 Participants |
| Mechanically Ventilated Participants | Number of Participants With Acute Cor Pulmonale | Day 3, n=43 | 8 Participants |
Secondary
Number of Participants With Pulmonary Circulatory Dysfunction
Pulmonary circulatory dysfunction is defined as moderate dysfunction (pulmonary arterial systolic pressure \[\>40 millimeters of mercury\] or a dilated RV end diastolic RV/left ventricle \[LV\] area ratio \[\>=0.6\] but without septal dyskinesia). At risk Population consisted of participants who satisfied following criteria: 1. pulmonary arterial systolic pressure and ratio of RV to LV end-diastolic area recorded for all three study days \[regardless of the Ang II and Ang(1-7) status\] and/or; 2. databased acute cor pulmonale/pulmonary circulatory dysfunction and/or acute respiratory distress syndrome (ARDS) assessment during the study period (even if they do not have three days worth of study assessments for the echo outcomes) were evaluated for acute cor pulmonale/pulmonary circulatory dysfunction and ARDS incidence rates. Number of participants with Pulmonary Circulatory Dysfunction have been reported.
Time frame: Days 1, 2 and 3
Population: At risk Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mechanically Ventilated Participants | Number of Participants With Pulmonary Circulatory Dysfunction | Day 3, n=43 | 5 Participants |
| Mechanically Ventilated Participants | Number of Participants With Pulmonary Circulatory Dysfunction | Day 1, n=56 | 18 Participants |
| Mechanically Ventilated Participants | Number of Participants With Pulmonary Circulatory Dysfunction | Day 2, n=52 | 12 Participants |
Secondary
Number of Participants With Severe Acute Cor Pulmonale
Severe acute cor pulmonale is defined as severely dilated RV (end-diastolic RV/LV area ratio \>=1) with septal dyskinesia. Number of participants with severe acute cor pulmonale have been reported.
Time frame: Days 1, 2 and 3
Population: At risk Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mechanically Ventilated Participants | Number of Participants With Severe Acute Cor Pulmonale | Day 1, n=56 | 3 Participants |
| Mechanically Ventilated Participants | Number of Participants With Severe Acute Cor Pulmonale | Day 2, n=52 | 0 Participants |
| Mechanically Ventilated Participants | Number of Participants With Severe Acute Cor Pulmonale | Day 3, n=43 | 0 Participants |
Secondary
Pearson Correlation Coefficient Between PASP and Ang(1-7)
Pearson correlation coefficient between PASP and Ang(1-7) was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS.
Time frame: Up to Day 3
Population: Evaluable Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mechanically Ventilated Participants | Pearson Correlation Coefficient Between PASP and Ang(1-7) | -0.050 Unitless |
Secondary
Pearson Correlation Coefficient Between PASP and Ang II/Ang(1-7)
Pearson correlation coefficient between PASP and Ang II/Ang(1-7) was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS.
Time frame: Up to Day 3
Population: Evaluable Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mechanically Ventilated Participants | Pearson Correlation Coefficient Between PASP and Ang II/Ang(1-7) | 0.193 Unitless |
Secondary
Pearson Correlation Coefficient Between RV Size Ratio and Ang(1-7)
Pearson correlation coefficient between RV size ratio and Ang(1-7) was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS.
Time frame: Up to Day 3
Population: Evaluable Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mechanically Ventilated Participants | Pearson Correlation Coefficient Between RV Size Ratio and Ang(1-7) | 0.350 Unitless |
Secondary
Pearson Correlation Coefficient Between RV Size Ratio and Ang II/Ang(1-7)
Pearson correlation coefficient between RV size ratio and Ang II/Ang(1-7) was derived using all available data from participants in the evaluable population. Pearson's correlation coefficient is a measure of the linear dependence between 2 variables. A correlation of +1 or -1 may occur if the data from the 2 variables lie exactly on a line. Pearson's correlation coefficient was calculated using SAS.
Time frame: Up to Day 3
Population: Evaluable Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mechanically Ventilated Participants | Pearson Correlation Coefficient Between RV Size Ratio and Ang II/Ang(1-7) | -0.032 Unitless |
Secondary
Renin-angiotensin System Cascade Biomarker: Ang(1-7) Level
Blood samples were collected for renin-angiotensin system biomarkers at indicated time points.
Time frame: Days 1, 2 and 3
Population: Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mechanically Ventilated Participants | Renin-angiotensin System Cascade Biomarker: Ang(1-7) Level | Day 1, n=44 | 6.038 Picograms per milliliter | Standard Deviation 11.7629 |
| Mechanically Ventilated Participants | Renin-angiotensin System Cascade Biomarker: Ang(1-7) Level | Day 2, n=44 | 6.020 Picograms per milliliter | Standard Deviation 11.3192 |
| Mechanically Ventilated Participants | Renin-angiotensin System Cascade Biomarker: Ang(1-7) Level | Day 3, n=36 | 4.911 Picograms per milliliter | Standard Deviation 7.8364 |
Secondary
Renin-angiotensin System Cascade Biomarker: Ang II/ Ang(1-7) Ratio
Blood samples were collected for renin-angiotensin system biomarkers at indicated time points.
Time frame: Days 1, 2 and 3
Population: Evaluable Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mechanically Ventilated Participants | Renin-angiotensin System Cascade Biomarker: Ang II/ Ang(1-7) Ratio | Day 1, n=44 | 10.620 Ratio | Standard Deviation 10.1424 |
| Mechanically Ventilated Participants | Renin-angiotensin System Cascade Biomarker: Ang II/ Ang(1-7) Ratio | Day 2, n=43 | 9.184 Ratio | Standard Deviation 7.3338 |
| Mechanically Ventilated Participants | Renin-angiotensin System Cascade Biomarker: Ang II/ Ang(1-7) Ratio | Day 3, n=35 | 7.938 Ratio | Standard Deviation 8.0332 |