Study of Renin-angiotensin System in Mechanically Ventilated Subjects

NCT ID: NCT03212690

Last Updated: 2020-04-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-11
• Study Completion Date: 2019-07-08

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.

Conditions

Acute Lung Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Mechanically ventilated subjects

Subjects receiving invasive mechanical ventilation (Duration of ventilation \<=48 hours) will be evaluated using standard care investigations.

Group Type: EXPERIMENTAL

Local standard of care

Intervention Type: DRUG

Local standard of care will include fluid resuscitation, use of vasopressor drugs and renal support.

Mechanical ventilation

Intervention Type: PROCEDURE

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).

Interventions

Local standard of care

Local standard of care will include fluid resuscitation, use of vasopressor drugs and renal support.

Intervention Type: DRUG

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).

Intervention Type: PROCEDURE

Eligibility 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Boulogne-Billancourt, , France

GSK Investigational Site

Créteil, , France

Countries

France

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

2017-A01653-50

Identifier Type: REGISTRY

Identifier Source: secondary_id

205821

Identifier Type: -

Identifier Source: org_study_id