Clinical trial NCT01714583: The Relationship Between Positive End Expiratory Pressure and Cardiac Index in Patients With Acute Respiratory Distress Syndrome (ARDS) Managed on a Fluid Protocol
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome (ARDS)
Keywords: Mechanical ventilation
ARDS
acute lung injury
cardiac function
cardiac index
heart-lung interaction
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2012-10-26
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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. We 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.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cardiac Index
timeFrame: Cross sectional (i.e. at time Zero only)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine
state: Connecticut
Study officials:
affiliation: Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine
name: Wassim H Fares, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fares WH, Carson SS; NIH NHLBI ARDS Network. The relationship between positive end-expiratory pressure and cardiac index in patients with acute respiratory distress syndrome. J Crit Care. 2013 Dec;28(6):992-7. doi: 10.1016/j.jcrc.2013.06.021. Epub 2013 Aug 28.