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

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Accession Number
HLB00650808a

Study Type
Clinical Trial

Collection Type
Open BioLINCC Study See bottom of this webpage for request information

Study Period
2000-2005

NHLBI Division
DLD

Dataset(s) Last Updated
August 5, 2024

Study Website
http://www.ardsnet.org/

Clinical Trial URLs
NCT00000579

Primary Publication URLs
16714767
16714768

Consent

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.

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.

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)

Additional Details

Subjects:

Updated 31st October 2025.

 

PAC/fluid liberal: 252

PAC/fluid conservative: 261

CVC/fluid liberal: 245

CVC/fluid conservative: 242

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.

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

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

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:

Serum, plasma, DNA

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

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

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Resources Available

Specimens and Study Datasets

Study Catalog

Study Publications (72)

Materials Available

Study Documents

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