Randomized Trial of Inhaled Nitric Oxide to Augment Tissue Perfusion in Sepsis

Completed · Phase 3 · Has a placebo group

Conditions studied: Sepsis

In brief

The purpose of this study is to determine whether inhaled nitric oxide is an effective treatment for microcirculatory dysfunction and acute organ system failure in the early stage of sepsis therapy.

Key facts

Study ID

NCT00608322

Run by

National Institute of General Medical Sciences (NIGMS)

People needed

49

Starts

2009-08-01

Expected to finish

2013-04-01

Last updated by the study team

2013-07-11

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed or suspected infection (acute)
• PLUS:
• One or both of the following criteria for potential tissue hypoperfusion:
• (2a) systolic blood pressure <90 mmHg despite 30cc/kg intravenous crystalloid challenge, OR (2b) serum lactate >4 mmol/L.

You may not qualify if…

• age < 14 years
• pregnancy
• "Do Not Resuscitate" status (prior to enrollment)
• active clinically significant bleeding of any etiology
• status-post cardiac arrest
• need for immediate surgery
• inability to place a sublingual videomicroscopy probe under the tongue (e.g. inability to open the mouth or patient requirement of a high-flow face mask for supplemental oxygen [although videomicroscopy can be performed in patients with an endotracheal tube or nasal cannula])
• >24 hours elapsed since first documented evidence of meeting criteria for potential tissue hypoperfusion (2a or 2b above).
• inability to obtain written informed consent

Where it is running

• Cooper University Hospital — Camden, New Jersey, United States

Full record on ClinicalTrials.gov

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