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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00608322
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : July 11, 2013
Last Update Posted : July 11, 2013
Information provided by (Responsible Party):
Dr. Trzeciak, The Cooper Health System

Brief 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.

Condition or disease Intervention/treatment Phase
Sepsis Drug: Inhaled nitric oxide Other: Sham inhaled nitric oxide Phase 3

  Show Detailed Description

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Change in the Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: 0-24 hours from protocol initiation ]
  2. 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.

Secondary Outcome Measures :
  1. 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, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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 identifier (NCT number): 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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Trzeciak, PI, The Cooper Health System 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, The Cooper Health System:
Severe sepsis
Septic shock

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