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

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
https://clinicaltrials.gov/ct2/show/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
https://www.ncbi.nlm.nih.gov/pubmed/16714767
https://www.ncbi.nlm.nih.gov/pubmed/16714768
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

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

  • Subjects

    PAC/fluid liberal: 252

    PAC/fluid conservative: 261

    CVC/fluid liberal: 245

    CVC/fluid conservative: 242


    Last Modified: June 22, 2022, 10:54 a.m.
  • Age

     

    PAC/Fluid

    Liberal

    PAC/Fluid

    Conservative

    CVC/Fluid

    Liberal

    CVC/Fluid

    Conservative

    All

    N

    %

    N

    %

    N

    %

    N

    %

    N

    %

    16-20

    3

    1.19

    6

    2.30

    7

    2.86

    8

    3.31

    24

    2.40

    21-25

    8

    3.17

    14

    5.36

    13

    5.31

    10

    4.13

    45

    4.50

    26-30

    16

    6.35

    10

    3.83

    14

    5.71

    11

    4.55

    51

    5.10

    31-35

    23

    9.13

    19

    7.28

    16

    6.53

    15

    6.20

    73

    7.30

    36-40

    29

    11.51

    29

    11.11

    29

    11.84

    23

    9.50

    110

    11.00

    41-45

    30

    11.90

    34

    13.03

    28

    11.43

    24

    9.92

    116

    11.60

    46-50

    27

    10.71

    31

    11.88

    29

    11.84

    34

    14.05

    121

    12.10

    51-55

    27

    10.71

    30

    11.49

    27

    11.02

    31

    12.81

    115

    11.50

    56-60

    23

    9.13

    26

    9.96

    26

    10.61

    20

    8.26

    95

    9.50

    61-65

    17

    6.75

    16

    6.13

    15

    6.12

    23

    9.50

    71

    7.10

    66-70

    15

    5.95

    15

    5.75

    17

    6.94

    8

    3.31

    55

    5.50

    71-75

    15

    5.95

    13

    4.98

    11

    4.49

    17

    7.02

    56

    5.60

    76-80

    12

    4.76

    8

    3.07

    8

    3.27

    9

    3.72

    37

    3.70

    81-85

    3

    1.19

    4

    1.53

    3

    1.22

    9

    3.72

    19

    1.90

    86-90

    4

    1.59

    6

    2.30

    2

    0.82

    .

    .

    12

    1.20
     

    Last Modified: June 22, 2022, 10:54 a.m.
  • Sex
     

     

    PAC/Fluid

    Liberal

    PAC/Fluid

    Conservative

    CVC/Fluid

    Liberal

    CVC/Fluid

    Conservative

    All

    N

    %

    N

    %

    N

    %

    N

    %

    N

    %

    Female

    141

    55.95

    134

    51.34

    130

    53.06

    129

    53.31

    534

    53.40

    Male

    111

    44.05

    127

    48.66

    115

    46.94

    113

    46.69

    466

    46.60
     

    Last Modified: June 22, 2022, 10:54 a.m.
  • Race

     

    PAC/Fluid

    Liberal

    PAC/Fluid

    Conservative

    CVC/Fluid

    Liberal

    CVC/Fluid

    Conservative

    All

    N

    %

    N

    %

    N

    %

    N

    %

    N

    %

    White non-Hispanic

    160

    63.49

    173

    66.28

    153

    62.45

    155

    64.05

    641

    64.10

    Black non-Hispanic

    61

    24.21

    51

    19.54

    57

    23.27

    48

    19.83

    217

    21.70

    Other

    31

    12.30

    37

    14.18

    35

    14.29

    39

    16.12

    142

    14.20
     

    Last Modified: June 22, 2022, 10:54 a.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 of the BioLINCC handbook describes the components of the review process

  • Material Types
  • General Freeze/Thaw Status
  • Visits (Vials)

    11/01/2022

      Serum Plasma Total
    Day 0 25 4,291 4,316
    Day 1 32 9,437 9,469
    Day 3 53 4,801 4,854
    Day 7 36 6,733 6,769

    Last Modified: Nov. 1, 2022, 9:39 a.m.
  • Visits (Subjects)

    11/01/2022

      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 10.16
    Day 3 859 4.78
    Day 7 678 9.27

    Last Modified: Nov. 1, 2022, 9:39 a.m.