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

This study has been completed.
Information provided by (Responsible Party):
Dr. Trzeciak, Cooper University Hospital
ClinicalTrials.gov Identifier:
First received: January 23, 2008
Last updated: June 3, 2013
Last verified: June 2013
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.

Condition Intervention Phase
Drug: Inhaled nitric oxide
Other: Sham inhaled nitric oxide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Further study details as provided by National Institute of General Medical Sciences (NIGMS):

Primary Outcome Measures:
  • Change in the Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: 0-24 hours from protocol initiation ] [ Designated as safety issue: No ]
  • Change in Sublingual Microcirculatory Flow Index (MFI) [ Time Frame: 0-2 hours of study drug administration ] [ Designated as safety issue: No ]
    The MFI is a continuous scale from 0-3, with 3.0 being better outcome and 0.0 being worse outcome.

Secondary Outcome Measures:
  • Lactate Clearance (Blood) [ Time Frame: 0-2 hours of study drug administration ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: August 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
Drug: Inhaled nitric oxide
Inhaled nitric oxide, 40 parts per million, for six hours.
Other Name: INOmax
Sham Comparator: 2
Subjects receive sham inhaled nitric oxide for six hours.
Other: Sham inhaled nitric oxide
Sham inhaled nitric oxide administration, 0 parts per million, for six hours.

  Show Detailed Description


Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Confirmed or suspected infection (acute)


  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00608322

United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
National Institute of General Medical Sciences (NIGMS)
Principal Investigator: Stephen Trzeciak, MD, MPH UMDNJ-Robert Wood Johnson Medical School at Camden, Cooper University Hospital, Camden, New Jersey
  More Information

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  1K23GM083211-01 
Study First Received: January 23, 2008
Results First Received: April 16, 2013
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by National Institute of General Medical Sciences (NIGMS):
Severe sepsis
Septic shock

Additional relevant MeSH terms:
Pathologic Processes
Systemic Inflammatory Response Syndrome
Nitric Oxide
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Endothelium-Dependent Relaxing Factors
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 30, 2016