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

This study has been completed.
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01714583
First received: October 19, 2012
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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.


Condition
Acute Respiratory Distress Syndrome (ARDS)

Study Type: Observational
Study Design: Time Perspective: Retrospective
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

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Cardiac Index [ Time Frame: Cross sectional (i.e. at time Zero only) ] [ Designated as safety issue: No ]

    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.



Enrollment: 367
Study Start Date: April 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
High PEEP
Cohort of participants with positive end-expiratory pressure (PEEP) greater than or equal to 12cm.
Low PEEP
Cohort of participants with positive end-expiratory pressure (PEEP) less than 12cm.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01714583

Locations
United States, Connecticut
Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Wassim H Fares, MD MSc Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine
  More Information

No publications provided by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01714583     History of Changes
Other Study ID Numbers: NHLBI T32 HL007106-34
Study First Received: October 19, 2012
Last Updated: October 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Mechanical ventilation
ARDS
acute lung injury
cardiac function
cardiac index
heart-lung interaction

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on July 23, 2014