Acute Respiratory Distress Network (ARDSNet) Study 05 Fluid and Catheter Treatment Trial (FACTT)
Study Type
Clinical Trial
Collection Type
Open BioLINCC Study
See bottom of this webpage for request information
Study Period
2000-2005
NHLBI Division
DLD
Date Prepared
October 13, 2008
Last Updated
August 24, 2006
Clinical Trial URLs
http://clinicaltrials.gov/ct2/sh...
Primary Publication URLs
https://www.ncbi.nlm.nih.gov/pub...
https://www.ncbi.nlm.nih.gov/pub...
Study Website
http://www.ardsnet.org/
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.
Subjects
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
PAC/fluid liberal: 252
PAC/fluid conservative: 261
CVC/fluid liberal: 245
CVC/fluid conservative: 242
|
|
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 |
|
|
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 |
|
|
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 |
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5/11/2017
| Serum | Plasma | Total | |
|---|---|---|---|
| Day 0 | 25 | 6,679 | 6,704 |
| Day 1 | 32 | 9,688 | 9,720 |
| Day 3 | 53 | 6,287 | 6,340 |
| Day 7 | 36 | 8,508 | 8,544 |
| Unknown | 0 | 16 | 16 |
5/11/2017
| 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 | 14.50 |
| Day 1 | 912 | 11.87 |
| Day 3 | 859 | 10.77 |
| Day 7 | 678 | 10.82 |
| Unknown | 4 | 1.26 |
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