Status:
COMPLETED
Endothelium in Severe Sepsis
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sepsis
Severe Sepsis
Eligibility:
All Genders
18+ years
Brief Summary
The overall hypotheses of this project is that severe sepsis is associated with endothelial dysfunction; that endothelial dysfunction, in turn, is predictive of subsequent organ failure and death; and...
Detailed Description
The endothelial response is emerging as a critical element of sepsis pathophysiology. Preclinical data and small human studies suggest that endothelial cells are responsible for increased leukocyte ad...
Eligibility Criteria
Inclusion
- Enrolled as a participant in the ProCESS Trial (clinicaltrial.gov identifier NCT00510835)
- At least 18 years of age
- Suspected infection
- Two or more systemic inflammatory response syndrome (SIRS) criteria
- Temperature \</= 36˚ C or \>/= 38˚C
- Heart rate \>/= 90 beats per minute
- Mechanical ventilation for acute respiratory process or respiratory rate \>/= 20 breaths per minute or PaC02 \< 32 mmHg
- WBC \>/= 12,000/mm³ OR \</= 4,000/mm³ OR \> 10% bands
- Refractory hypotension (a systolic blood pressure \< 90 mm Hg despite an IV fluid challenge of at least 20 ml/kg over a 30 minute period) or evidence of hypoperfusion (a blood lactate concentration \>/= 4 mmol/L)
Exclusion
- Known pregnancy
- Primary diagnosis of acute cerebral vascular event, acute coronary syndrome, -- acute pulmonary edema, status asthmaticus, major cardiac arrhythmia, active
- gastrointestinal hemorrhage, seizure, drug overdose, burn or trauma
- Requirement for immediate surgery
- ANC \< 500/mm³
- CD4 \< 50/mm³
- Do-not-resuscitate status
- Advanced directives restricting implementation of the protocol
- Contraindication to central venous catheterization
- Contradiction to blood transfusion (e.g., Jehovah's Witness)
- Treating physician deems aggressive care unsuitable
- Participation in another interventional study
- Transferred from another in-hospital setting
- inability to tolerate microscan procedure (eg oxygen requirement via face mack that can not be discontinue for the procedure)
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
910 Patients enrolled
Trial Details
Trial ID
NCT00793442
Start Date
March 1 2008
End Date
May 1 2013
Last Update
October 29 2024
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Universtiy of Alabama
Birmingham, Alabama, United States, 35249
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
4
North Shore University Hospital
Manhasset, New York, United States, 11030