The Relationship Between Positive End Expiratory Pressure and Cardiac Index in Patients With Acute Respiratory Distress Syndrome (ARDS) Managed on a Fluid Protocol

Acute Respiratory Distress Syndrome (ARDS) Clinical Trial

Official title:

The Relationship Between Positive End Expiratory Pressure and Cardiac Index in Patients With ARDS Managed on a Fluid Protocol: A Secondary Analysis of a Prospective Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01714583
• Other study ID #: NHLBI T32 HL007106-34
• Status: Completed
• Phase: N/A
• First received: October 19, 2012
• Last updated: October 25, 2012
• Start date: April 2011
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The objective of this study is to evaluate the association between positive end-expiratory pressure (PEEP) setting and cardiac function, as measured by cardiac index, in patients with acute respiratory distress syndrome (ARDS) who were managed on the NHLBI ARDS Network Fluid and Catheter Treatment Trial (FACTT) fluid protocols.

Description:

This is a secondary cross-sectional analysis of the FACTT multi-center randomized controlled trial enrolling adult patients within 48 hours of ARDS onset from twenty medical centers across the US, some of which included more than one hospital. We studied the patients who were randomized to the pulmonary artery catheter arm of the FACTT study. The investigators included patients that had PEEP and cardiac index measurements performed within a short period of each other during the first 3 days of the FACTT study enrollment. Since FACTT had a 2x2 factorial design, half of the patients were in a 'liberal fluids' study arm, and the other half were in a 'conservative fluids' study arm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Acute lung injury diagnosis (as defined by The American - European Consensus Conference on ARDS) of < 48 hours in duration.

Patients in the Pulmonary Artery catheter (PAC) arm of the FACTT study. PaO2 / FiO2 ratio of < 200. Data from the first 3 days of mechanical ventilation.

Exclusion Criteria:

Select chronic conditions that could independently influence survival (e.g., expected 6-month survival < 50%) and / or ventilator weaning.

PEEP values missing. FiO2 values missing. PaO2 values missing. Cardiac index values missing Pressors and / or inotropes requirement.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome (ARDS)
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
United States	Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Index	The cardiac index is a cardiodynamic measure based on the cardiac output, which is the amount of blood the left ventricle ejects into the systemic circulation in one minute, measured in liters per minute (l/min). Cardiac output is indexed to a patient's body size by dividing by the body surface area to yield the cardiac index.; The cardiac index which is the outcome measure is assessed at the same time as the PEEP (which is the independent variable) is measured.; The study participants are NOT followed for any period of time. This is a cross-sectional study design. Both variables (Cardiac index and PEEP) are measured at the same time.	Cross sectional (i.e. at time Zero only)	No