LandmarkRCT

FACTT

Comparison of Two Fluid-Management Strategies in Acute Lung Injury

New England Journal of Medicine, 2006 · Multicenter, randomized controlled trial (ARDSNet), unblinded, 2x2 factorial with a separate catheter-type comparison.

Clinical question

In acute lung injury/ARDS, does a conservative fluid-management strategy targeting an even fluid balance improve outcomes compared with a liberal strategy, once shock has resolved?

Population: 1,000 patients with acute lung injury or ARDS, enrolled once free of shock requiring vasopressors.
Inclusion criteria: Acute lung injury or ARDS by the contemporaneous consensus definition.
No longer in shock requiring vasopressor support at enrollment.
Intervention: Conservative fluid strategy: protocol-driven diuresis or fluid restriction targeting an even-to-negative fluid balance.
Comparator: Liberal fluid strategy: protocol-driven fluid administration targeting a more net-positive balance.
Primary outcome: 60-day mortality.
Secondary outcomes: Ventilator-free days through day 28.
ICU length of stay.
Non-pulmonary organ failure.
Result: No mortality difference between strategies, but the conservative strategy improved lung function and shortened the duration of mechanical ventilation and ICU stay without increasing non-pulmonary organ failure. (60-day mortality 25.5% (conservative) vs 28.4% (liberal), p = 0.30)

What the trial found

A conservative, restrictive fluid strategy after the shock phase did not reduce mortality compared with a more liberal strategy, but it produced more ventilator-free days and a shorter ICU stay, without an increase in shock or need for renal replacement therapy.

Current guideline position

While guidelines do not recommend a single rigid fluid protocol, a conservative fluid strategy after initial hemodynamic stabilization is widely adopted as standard supportive care in ARDS management.

Clinical interpretation

FACTT is the basis for a 'dry after resuscitation' approach in ARDS: once a patient is no longer in shock, avoiding a positive fluid balance shortens time on the ventilator and in the ICU, even though it has not been shown to change 60-day survival on its own. It does not address fluid strategy during the initial resuscitation/shock phase, when adequate perfusion still takes priority.

Limitations

Unblinded, protocol-driven fluid management, as is unavoidable for this design.
Excluded patients still in shock, so it does not inform fluid strategy during initial resuscitation.
Mortality was a secondary, not primary, finding of benefit — the functional outcomes (ventilator-free days, ICU stay) were the strategy's clearest benefit.

Moderate certainty

Clinical Context & Relevant Topics (1)

Disease Reference

Acute Respiratory Distress Syndrome

Acute, diffuse inflammatory lung injury causing hypoxemia and bilateral infiltrates not fully explained by cardiac failure or fluid overload.

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