Phase 3
Completed N=49
Randomized Trial of Inhaled Nitric Oxide to Augment Tissue Perfusion in Sepsis
Source: ClinicalTrials.gov NCT00608322 ↗Enrolled (actual)
49
Serious AEs
30.6%
Results posted
Jul 2013
Primary outcomePrimary: Change in the Sequential Organ Failure Assessment (SOFA) Score
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Sequential Organ Failure Assessment (SOFA) Score |
— | — |
| PRIMARY Change in Sublingual Microcirculatory Flow Index (MFI) |
-0.06; -0.03 | 0.37 |
| SECONDARY Lactate Clearance (Blood) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed or suspected infection (acute)
PLUS:
- One or both of the following criteria for potential tissue hypoperfusion:
(2a) systolic blood pressure 4 mmol/L.
Exclusion Criteria
- age 24 hours elapsed since first documented evidence of meeting criteria for potential tissue hypoperfusion (2a or 2b above).
- inability to obtain written informed consent
Data sourced from ClinicalTrials.gov (NCT00608322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.