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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Institute of General Medical Sciences (NIGMS).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00608322
First received: January 23, 2008
Last updated: August 10, 2009
Last verified: August 2009
History of Changes
  Purpose

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
Sepsis
 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:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

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 ]

Secondary Outcome Measures:
  • Change in sublingual Microcirculatory Flow Index (MFI) [ Time Frame: 0-2 hours of study drug administration ] [ Designated as safety issue: No ]
  • Lactate clearance (blood) [ Time Frame: 0-2 hours of study drug administration ] [ Designated as safety issue: No ]

Estimated Enrollment: 138
Study Start Date: August 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (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

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608322

Contacts
Contact: Stephen Trzeciak, MD, MPH 856-342-3342 trzeciak-stephen@cooperhealth.edu

Locations
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Stephen Trzeciak, MD, MPH     856-342-3342     trzeciak-stephen@cooperhealth.edu    
Principal Investigator: Stephen Trzeciak, MD, MPH            
Sub-Investigator: Steven M Hollenberg, MD            
Sub-Investigator: R. Phillip Dellinger, MD            
Sub-Investigator: Joseph E. Parrillo, MD            
Sponsors and Collaborators
National Institute of General Medical Sciences (NIGMS)
Investigators
Principal Investigator: Stephen Trzeciak, MD, MPH UMDNJ-Robert Wood Johnson Medical School at Camden, Cooper University Hospital, Camden, New Jersey
  More Information

Publications:

Responsible Party: Stephen Trzeciak, MD, MPH, UMDNJ-Robert Wood Johnson Medical School at Camden, Cooper University Hospital
ClinicalTrials.gov Identifier: NCT00608322     History of Changes
Other Study ID Numbers: K23GM083211, 1 K23 GM083211-01
Study First Received: January 23, 2008
Last Updated: August 10, 2009
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by National Institute of General Medical Sciences (NIGMS):
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
Pharmacologic Actions
 Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013