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
January 3, 2018

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

Clinical Trial URLs
https://clinicaltrials.gov/ct2/show/NCT00000579

Primary Publication URLs
https://www.ncbi.nlm.nih.gov/pubmed/16714767
https://www.ncbi.nlm.nih.gov/pubmed/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:

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

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
 
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
 
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
 

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

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
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

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Resources Available

Specimens and Study Datasets

Study Catalog

Study Publications (69)

Materials Available

Study Documents

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