Sepsis Clinical Trial
Official title:
Randomized Double-blind Placebo-controlled Trial of Inhaled Nitric Oxide for the Treatment of Microcirculatory Dysfunction and Organ Failure in Sepsis
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | April 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 14 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cooper University Hospital | Camden | New Jersey |
Lead Sponsor | Collaborator |
---|---|
National Institute of General Medical Sciences (NIGMS) |
United States,
Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. — View Citation
Sakr Y, Dubois MJ, De Backer D, Creteur J, Vincent JL. Persistent microcirculatory alterations are associated with organ failure and death in patients with septic shock. Crit Care Med. 2004 Sep;32(9):1825-31. — View Citation
Trzeciak S, Dellinger RP, Parrillo JE, Guglielmi M, Bajaj J, Abate NL, Arnold RC, Colilla S, Zanotti S, Hollenberg SM; Microcirculatory Alterations in Resuscitation and Shock Investigators. Early microcirculatory perfusion derangements in patients with severe sepsis and septic shock: relationship to hemodynamics, oxygen transport, and survival. Ann Emerg Med. 2007 Jan;49(1):88-98, 98.e1-2. Epub 2006 Nov 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the Sequential Organ Failure Assessment (SOFA) Score | 0-24 hours from protocol initiation | No | |
Primary | Change in Sublingual Microcirculatory Flow Index (MFI) | The MFI is a continuous scale from 0-3, with 3.0 being better outcome and 0.0 being worse outcome. | 0-2 hours of study drug administration | No |
Secondary | Lactate Clearance (Blood) | 0-2 hours of study drug administration | No |
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