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Completed

NCT Number: NCT01714583

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Cardiac Index

    Time frame: Cross sectional (i.e. at time Zero only)

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 26, 2012
Registry last updated
Oct 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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