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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of General Medical Sciences (NIGMS)
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

1. Confirmed or suspected infection (acute)

PLUS:

2. 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.

Exclusion Criteria:

1. age < 14 years

2. pregnancy

3. "Do Not Resuscitate" status (prior to enrollment)

4. active clinically significant bleeding of any etiology

5. status-post cardiac arrest

6. need for immediate surgery

7. 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])

8. >24 hours elapsed since first documented evidence of meeting criteria for potential tissue hypoperfusion (2a or 2b above).

9. inability to obtain written informed consent