NCT00000579

Acute Respiratory Distress Syndrome Clinical Network (ARDSNet)

Completed Phase 3 Last updated 22 March 2016

What this trial tests

Phase 3 trial testing Low Tidal Volume Ventilation in Respiratory Distress Syndrome, Adult. Completed in 1 July 2004.

Timeline

1 September 1994

1 July 2004

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Design	factorial
Primary purpose	treatment
Start date	1 September 1994
Estimated completion	1 July 2004
Sites	21 locations across United States, Canada

Drugs / interventions tested

• Low Tidal Volume Ventilation
• Positive End-Expiratory Pressure
• Lysofylline — full drug profile →
• Methylprednisolone (methylprednisolone) — full drug profile →
• Ketoconazole (ketoconazole) — full drug profile →
• Fluid Management
• Pulmonary Artery Catheter

Conditions studied

• Respiratory Distress Syndrome, Adult — all drugs for Respiratory Distress Syndrome, Adult →
• Lung Diseases — all drugs for Lung Diseases →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

13 and older, any sex, with Respiratory Distress Syndrome, Adult or Lung Diseases. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Vary by protocol

Sponsor's own description

The purposes of this study are to assess rapidly innovative treatment methods in patients with adult respiratory distress syndrome (ARDS) as well as those at risk of developing ARDS and to create a network of interactive Critical Care Treatment Groups (CCTGs) to establish and maintain the required infrastructure to perform multiple therapeutic trials that may involve investigational drugs, approved agents not currently used for treatment of ARDS, or treatments currently used but whose efficacy has not been well documented.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mechanical ventilation guided by esophageal pressure in acute lung injury.
   Talmor D, Sarge T, Malhotra A, O'Donnell CR, et al · · 2008 · cited 721× · PMID 19001507 · DOI 10.1056/nejmoa0708638
2. High Positive End-Expiratory Pressure Is Associated with Improved Survival in Obese Patients with Acute Respiratory Distress Syndrome.
   Bime C, Bime C, Fiero M, Lu Z, et al · · 2017 · cited 31× · PMID 27984004 · DOI 10.1016/j.amjmed.2016.09.029
3. Vitamin D Status and Clinical Outcomes in Acute Respiratory Distress Syndrome: A Secondary Analysis From the Assessment of Low Tidal Volume and Elevated End-Expiratory Volume to Obviate Lung Injury (ALVEOLI) Trial.
   Quraishi SA, Bhan I, Matthay MA, Thompson BT, et al · · 2022 · cited 7× · PMID 34165010 · DOI 10.1177/08850666211028139
4. What is the optimal approach to analyse ventilator-free days? A simulation study.
   Renard Triché L, Jabaudon M, Molinari N, Forel JM, et al · · 2025 · cited 4× · PMID 40537834 · DOI 10.1186/s13054-025-05474-9