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.
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
First received: October 19, 2012
Last updated: October 25, 2012
Last verified: October 2012
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.
Acute Respiratory Distress Syndrome (ARDS)
||Time Perspective: Retrospective
||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
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2012 (Final data collection date for primary outcome measure)
Cohort of participants with positive end-expiratory pressure (PEEP) greater than or equal to 12cm.
Cohort of participants with positive end-expiratory pressure (PEEP) less than 12cm.
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.
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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.
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01714583
|Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine
|New Haven, Connecticut, United States, 06510 |
University of North Carolina, Chapel Hill
||Wassim H Fares, MD MSc
||Yale University, School of Medicine, Department of Internal Medicine, Section of Pulmonary and Critical Care Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
History of Changes
|Other Study ID Numbers:
NHLBI T32 HL007106-34
|Study First Received:
||October 19, 2012
||October 25, 2012
||United States: Institutional Review Board
Keywords provided by Yale University:
acute lung injury
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 23, 2016
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases