Acute Respiratory Distress Network (ARDSNet) Study 05 Fluid and Catheter Treatment Trial (FACTT) - Catalog

  • Name

    Acute Respiratory Distress Network (ARDSNet) Study 05 Fluid and Catheter Treatment Trial (FACTT)

  • Accession Number

    HLB00650808a

  • Acronym

    ARDSNet-FACTT

  • Related studies
  • BSI Study IDs

    AR5

  • Is public use dataset

    False

  • Keywords
  • Ingestion Status
    Released
  • Has Study Datasets

    True

  • Has Specimens

    True

  • Specimen ID Type
    Coded
  • Study Website

    http://www.ardsnet.org/

  • The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.

    False

  • Clinical Trial URLs
    NCT00000579
  • Study type
    Clinical Trial
  • Collection Type
    Open BioLINCC Study
  • Cohort type
    Both
  • Interventions

    Procedure: Low Tidal Volume VentilationProcedure: Positive End-Expiratory PressureDrug: LysofyllineDrug: MethylprednisoloneDrug: KetoconazoleProcedure: Fluid ManagementProcedure: Pulmonary Artery Catheter

  • Study Open Date (Data)

    2009-10-01

  • Study Open Date (Specimens)

    2010-04-09

  • Date materials available

    2008-10-13

  • Last updated

    2006-08-24

  • Study period

    2000-2005

  • Study Contacts
  • NHLBI Division

    DLD

  • Classification
    Lung
  • HIV study classification
    non-HIV
  • COVID study classification
    non-COVID
  • Pre-Website # of Specimens Shipped

    9348

  • # of Returned Specimens

    0

  • Primary Publication URLs
    16714767
    16714768
  • Commercial use data restrictions
    No
  • Data restrictions based on area of research
    No
  • Commercial use specimen restrictions
    Yes
  • Non-genetic use specimen restrictions based on area of use
    No
  • Genetic use of specimens allowed?
    Yes
  • Genetic use area of research restrictions
    Yes
  • Specific Consent Restrictions

    Use of biospecimens in genetic research is tiered to (1) research in acute respiratory distress syndrome (ARDS) and related disorders, or (2) research in other medical conditions. Biospecimens cannot be used directly to produce commercial products.

  • Conditions
    ALI
    ARDS
    Acute Lung Injury
    Lung Diseases
    Respiratory Distress Syndrome, Adult
  • Objectives

    This study evaluated the benefits and risks of Pulmonary Artery Catheters (PACs) in patients with established acute lung injury in a trial comparing hemodynamic management guided by a PAC with hemodynamic management guided by a central venous catheter (CVC) using an explicit management protocol.

  • Background

    Optimal fluid management in patients with acute lung injury is unknown. Diuresis or fluid restriction may improve lung function but could jeopardize extrapulmonary organ perfusion.

  • Participants

    This randomized study compared a conservative and a liberal strategy of fluid management using explicit protocols applied for seven days in 1000 patients with acute lung injury. The primary end point was death at 60 days. Secondary end points included the number of ventilator-free days and organ-failure-free days and measures of lung physiology.

  • Design
  • Conclusions

    Although there was no significant difference in the primary outcome of 60-day mortality, the conservative strategy of fluid management was associated with improved lung function and shortened the duration of mechanical ventilation and intensive care without increasing nonpulmonary-organ failures. These results support the use of a conservative strategy of fluid management in patients with acute lung injury. (NEJM June 15, 2006; Vol 354, No. 24, pp 2564-75; NEJM May 25, 2006; Vol 354, No. 21, pp 2213-24)

  • Disease classification
  • Publications
  • Mat types
    DNA
    Plasma
    Serum
  • Network
    Acute Respiratory Distress Network (ARDSNet)

The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.

  • Subjects

    Updated 31st October 2025.

     

    PAC/fluid liberal: 252

    PAC/fluid conservative: 261

    CVC/fluid liberal: 245

    CVC/fluid conservative: 242


    Last Modified: Oct. 31, 2025, 1:49 p.m.
  • Age

     

    PAC/Fluid Liberal

    PAC/Fluid Conservative

    CVC/Fluid Liberal

    CVC/Fluid Conservative

    Total Subjects

    16-20

    3

    6

    7

    8

    24

    21-25

    8

    14

    13

    10

    45

    26-30

    16

    10

    14

    11

    51

    31-35

    23

    19

    16

    15

    73

    36-40

    29

    29

    29

    23

    110

    41-45

    30

    34

    28

    24

    116

    46-50

    27

    31

    29

    34

    121

    51-55

    27

    30

    27

    31

    115

    56-60

    23

    26

    26

    20

    95

    61-65

    17

    16

    15

    23

    71

    66-70

    15

    15

    17

    8

    55

    71-75

    15

    13

    11

    17

    56

    76-80

    12

    8

    8

    9

    37

    81-85

    *S

    *S

    *S

    *S

    19

    86-90

    *S

    *S

    *S

    *S

    12

    Total

    252

    261

    245

    242

    1,000

    *S:  Values have been suppressed due to small counts.


    Last Modified: Oct. 31, 2025, 1:49 p.m.
  • Sex

     

    PAC/Fluid Liberal

    PAC/Fluid Conservative

    CVC/Fluid Liberal

    CVC/Fluid Conservative

    Total Subjects

    Female

    141

    134

    130

    129

    534

    Male

    111

    127

    115

    113

    466

    Total

    252

    261

    245

    242

    1,000


    Last Modified: Oct. 31, 2025, 1:49 p.m.
  • Race

     

    PAC/Fluid Liberal

    PAC/Fluid Conservative

    CVC/Fluid Liberal

    CVC/Fluid Conservative

    Total Subjects

    White non-Hispanic

    160

    173

    153

    155

    641

    Black non-Hispanic

    61

    51

    57

    48

    217

    Other

    31

    37

    35

    39

    142

    Total

    252

    261

    245

    242

    1,000


    Last Modified: Oct. 31, 2025, 1:49 p.m.

Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3.0 of the BioLINCC Handbook describes the components of the review process.

  • Material Types

    Serum, plasma, DNA


    Last Modified: Oct. 31, 2025, 1:49 p.m.
  • General Freeze/Thaw Status
  • Visits (Vials)

    Updated 31st October 2025.

     

    Serum

    Plasma

    DNA

    Total

    Day 0

    25

    4,294

    597

    4,916

    Day 1

    32

    10,130

    0

    10,162

    Day 3

    53

    5,828

    0

    5,881

    Day 7

    36

    7,430

    0

    7,466


    Last Modified: Oct. 31, 2025, 1:49 p.m.
  • Visits (Subjects)

     

    Serum

    Total number of subjects

    Average volume (ml) per subject

    Day 0

    2

    10.25

    Day 1

    3

    8.62

    Day 3

    4

    9.68

    Day 7

    3

    7.90

     

     

    Plasma

    Total number of subjects

    Average volume (ml) per subject

    Day 0

    936

    3.50

    Day 1

    912

    10.10

    Day 3

    859

    4.69

    Day 7

    678

    9.22

     

     

    DNA

    Total number of subjects

    Average mass (ug) per subject

    Day 0

    518

    802.23


    Last Modified: Oct. 31, 2025, 1:49 p.m.