Randomized Trial of Inhaled Nitric Oxide to Augment Tissue Perfusion in Sepsis
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ClinicalTrials.gov Identifier: NCT00608322 |
Recruitment Status
:
Completed
First Posted
: February 6, 2008
Results First Posted
: July 11, 2013
Last Update Posted
: July 11, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sepsis | Drug: Inhaled nitric oxide Other: Sham inhaled nitric oxide | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 49 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized Double-blind Placebo-controlled Trial of Inhaled Nitric Oxide for the Treatment of Microcirculatory Dysfunction and Organ Failure in Sepsis |
Study Start Date : | August 2009 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | April 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
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Drug: Inhaled nitric oxide
Inhaled nitric oxide, 40 parts per million, for six hours.
Other Name: INOmax
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Sham Comparator: 2
Subjects receive sham inhaled nitric oxide for six hours.
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Other: Sham inhaled nitric oxide
Sham inhaled nitric oxide administration, 0 parts per million, for six hours.
|
- Change in the Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: 0-24 hours from protocol initiation ]
- Change in Sublingual Microcirculatory Flow Index (MFI) [ Time Frame: 0-2 hours of study drug administration ]The MFI is a continuous scale from 0-3, with 3.0 being better outcome and 0.0 being worse outcome.
- Lactate Clearance (Blood) [ Time Frame: 0-2 hours of study drug administration ]

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Ages Eligible for Study: | 14 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608322
United States, New Jersey | |
Cooper University Hospital | |
Camden, New Jersey, United States, 08103 |
Principal Investigator: | Stephen Trzeciak, MD, MPH | UMDNJ-Robert Wood Johnson Medical School at Camden, Cooper University Hospital, Camden, New Jersey |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dr. Trzeciak, PI, Cooper University Hospital |
ClinicalTrials.gov Identifier: | NCT00608322 History of Changes |
Other Study ID Numbers: |
K23GM083211 ( U.S. NIH Grant/Contract ) 1K23GM083211-01 ( U.S. NIH Grant/Contract ) |
First Posted: | February 6, 2008 Key Record Dates |
Results First Posted: | July 11, 2013 |
Last Update Posted: | July 11, 2013 |
Last Verified: | June 2013 |
Keywords provided by Dr. Trzeciak, Cooper University Hospital:
Sepsis Severe sepsis Septic shock |
Additional relevant MeSH terms:
Sepsis Toxemia Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Nitric Oxide Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anti-Asthmatic Agents Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Gasotransmitters Protective Agents |