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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Trzeciak, Cooper University Hospital
ClinicalTrials.gov Identifier:
NCT00608322
First received: January 23, 2008
Last updated: June 3, 2013
Last verified: June 2013
  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:


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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
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: Dr. Trzeciak, PI, 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
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):
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
Gasotransmitters
Protective Agents

ClinicalTrials.gov processed this record on August 19, 2014