NCT03212690

Study of Renin-angiotensin System in Mechanically Ventilated Subjects

Study to Elucidate the Association of the Renin-angiotensin System and Right Ventricular Function in Mechanically Ventilated Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lung Injury

Interventions

Type	Name	Description
DRUG	Local standard of care	Local standard of care will include fluid resuscitation, use of vasopressor drugs and renal support.
PROCEDURE	Mechanical 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).

Timeline

• Start date: 2018-06-11
• Primary completion: 2019-07-08
• Completion: 2019-07-08
• First posted: 2017-07-11
• Last updated: 2020-04-01
• Results posted: 2020-04-01

Locations

2 sites across 1 country: France