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

NCT ID: NCT01714583

Last Updated: 2012-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

367 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-09-30

Brief Summary

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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

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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.

Conditions

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Acute Respiratory Distress Syndrome (ARDS)

Keywords

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Mechanical ventilation ARDS acute lung injury cardiac function cardiac index heart-lung interaction

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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High PEEP

Cohort of participants with positive end-expiratory pressure (PEEP) greater than or equal to 12cm.

No interventions assigned to this group

Low PEEP

Cohort of participants with positive end-expiratory pressure (PEEP) less than 12cm.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wassim H Fares, MD MSc

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23993772 (View on PubMed)

Other Identifiers

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NHLBI T32 HL007106-34

Identifier Type: -

Identifier Source: org_study_id