Last updated: 07/17/2024 17:29:40
Study of Renin-angiotensin system in mechanically ventilated subjects
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: Study to elucidate the association of the Renin-angiotensin system and right ventricular function in mechanically ventilated patients
Trial description: 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.
Primary purpose:
Diagnostic
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Absolute values of Ang II levels
Timeframe: Up to Day 3
Ratio of right ventricular to left ventricular end-diastolic area to evaluate association between plasma Ang II levels and RV function
Timeframe: Up to Day 3
Number of subjects with abnormal paradoxical septal motion to evaluate association between plasma Ang II levels and RV function
Timeframe: Up to Day 3
Absolute values of pulmonary arterial systolic pressure (PASP)
Timeframe: Up to Day 3
Secondary outcomes:
Number of subjects with presence of Pulmonary Circulatory Dysfunction (PCD) and severe PCD
Timeframe: Up to Day 3
Number of subjects with presence of Acute Cor Pulmonale (ACP) and severe ACP
Timeframe: Up to Day 3
Absolute values of Ang (1-7) levels
Timeframe: Up to Day 3
Ratio of Ang II/ Ang (1-7)
Timeframe: Up to Day 3
Ratio of right ventricular to left ventricular end-diastolic area to evaluate association between plasma Ang(1-7) levels, Ang II/Ang(1-7) ratio and RV function.
Timeframe: Up to Day 3
Number of subjects with abnormal Paradoxical septal motion to evaluate association between plasma Ang (1-7) levels, Ang II/Ang (1-7) ratio and RV function.
Timeframe: Up to Day 3
Absolute values of PASP to evaluate between plasma Ang (1-7) levels, Ang II/Ang (1-7) ratio and RV function.
Timeframe: Up to Day 3
Interventions:
Drug: Local standard of care
Procedure/surgery: Mechanical ventilation
Enrollment:
57
Observational study model:
Cohort
Primary completion date:
2019-08-07
Time perspective:
Prospective
Clinical publications:
Armand Mekontso Dessap, Kate Hanrott, William M. Powley, Andy Fowler, Andrew Bayliffe, François Bagate, David A. Hall, Aili L. Lazaar, David C.Budd, Antoine Vieillard Baron. Study to elucidate the association of the renin-angiotensin system and right ventricular function in mechanically ventilated patients. J Clin Med. 2022;(11):15
DOI: 10.3390/jcm11154362
PMID: NULL
Medical condition
Acute Lung Injury
Product
GSK2586881
Collaborators
Not applicable
Study date(s)
June 2018 to July 2019
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 80 Years
Accepts healthy volunteers
No
- 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).
- 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 exclusion criteria are met; however, in some instances it may not be possible to assess all of these criteria within the 48-hour window. In this case, a subject can be included and investigator will obtain the information when available.
Inclusion and exclusion criteria
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 exclusion criteria are met; however, in some instances it may not be possible to assess all of these criteria within the 48-hour window. In this case, a subject can be included and investigator will obtain the information when available.
- Chronic obstructive pulmonary disease (COPD) requiring long term oxygen treatment or home mechanical ventilation.
- Documented pre-existing chronic pulmonary hypertension.
- Massive pulmonary embolism (defined by pulmonary embolism with systemic hypotension [defined as a systolic arterial pressure less than 90 mmHg or a drop in systolic arterial pressure of at least 40 mmHg for at least 15 minutes (mins)] which is not caused by new onset arrhythmias) or shock (manifested by evidence of tissue hypo-perfusion and hypoxia, including an altered level of consciousness, oliguria, or cool, clammy extremities).
- Pulmonary vasculitis or pulmonary hemorrhage including diffuse alveolar hemorrhage.
- Lung transplantation within last 6 months.
- Cardiopulmonary arrest during concurrent illness.
- Any use of RAS modulators including Angiotensin Converting Enzyme (ACE) type 1 inhibitors, Renin inhibitors and Angiotensin Receptor Blockers within 4 days or 5.5 half live whichever is longer.
- Do not resuscitate status.
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
2019-08-07
Actual study completion date
2019-08-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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