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The Role of Angiopoietin, Tie-2, and Vascular Endothelial Growth Factor (VEGF) in Sepsis-Induced Multiple Organ Dysfunction Syndrome (MODS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00908635
First received: May 25, 2009
Last updated: May 26, 2009
Last verified: May 2009
  Purpose

This study is designated to determine serum concentrations of inflammatory mediators Ang-1, Ang-2, Ang-1/Ang-2 ratio, and Tie-2 in patients with sepsis-induced MODS and to investigate the association among increased permeability, inflammatory mediators, and these serum mediators in development of organ failure.


Condition
Sepsis
Multiple Organ Dysfunction Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Angiopoietin, Angiopoietin Receptor Tie-2, and Vascular Endothelial Growth Factor in Sepsis-Induced Multi-Organ Dysfunction Syndrome

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • mortality [ Time Frame: in hospital mortality ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • organ failure [ Time Frame: In ICU stay ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

whole blood


Estimated Enrollment: 120
Study Start Date: July 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
survivor
survivors of patients
fatalities
non-survivors of patients

Detailed Description:

Multiple Organ Dysfunction Syndrome (MODS) frequently leads to death in patients with sepsis. Our previous work has demonstrated that endothelial injury is closely associated with MODS development and mortality in septic patients. The sepsis-induced damage of endothelial cell membrane gives rise to increased capillary permeability. Evidence suggests that increased capillary permeability in patients with sepsis was associated with higher incidence of MODS and death during the ICU stay than those with decreased permeability. Angiopoietin (Ang) system is the key mediator for maintaining capillary permeability. Ang-2 triggers an inflammatory response and inducing permeability by activating the endothelium. In contrast, Ang-1 is anti-inflammatory, can inhibit adhesion molecule expression and attenuate permeability increase in different stimuli. The disrupted angiopoietin system has been reported in patients with sepsis, but the association between angiotension and MODS in septic patients has not been well addressed.

This study is designated to determine serum concentrations of Ang-1, Ang-2, Ang-1/Ang-2 ratio, and Tie-2 in patients with sepsis-induced MODS and to investigate the association among increased permeability, inflammatory mediators,autonomic dysfunction, and these serum mediators in development of organ failure. In addition, the study will incubate endothelial cells with septic patients' serum or tumor necrosis factor (TNF)-alfa, and determine the effects of ang-1 administration and blockade of ang-2 on disruption of endothelial cell structure, permeability increase, and expression of adhesion molecules. The study will also determine the signaling pathways and altered NF-kB dimmer composition that is responsible for the inhibitory effect for ang-1 administration on TNF-alfa-induced intercellular adhesion molecule (ICAM)-1 expression on endothelial surface.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients admitted to ICU due to sepsis

Criteria

Inclusion Criteria:

  • Patients must have known origin of infection plus at least 2 of the following criteria of systemic inflammatory response syndrome:

    • fever > 38C or hypothermia < 36C;
    • heart rate > 90 beats/ minute;
    • respiratory rate > 20 breaths/minute or PaCO2< 32 mmHg or mechanical ventilation for an acute process;
    • WBC count > 12x109/L or < 4x109/L or > 10% immature neutrophils.

Exclusion Criteria:

  • Age less than 18 years,
  • Pregnant,
  • Inability to provide informed, written consent,
  • Patients with urologic trauma resulting in frank hematuria, urinary infection, or existing chronic renal disease (serum creatinine level > 2.0 mg/dL),
  • Patients receiving nephrotoxic drugs, admitted to the hospital following a surgical procedure, or remaining in the ICU for < 72 hours will be also excluded.
  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: NCT00908635

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Shu-Min Lin, MD    88633281200 ext 8467    smlin100@gmail.com   
Principal Investigator: Shu-Min Lin, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Shu-Min Lin, MD Chang Gung Memorial Hospital
  More Information

Publications:
Responsible Party: Shu-Min Lin, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00908635     History of Changes
Other Study ID Numbers: 96-1483B
Study First Received: May 25, 2009
Last Updated: May 26, 2009
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
sepsis
organ failure

Additional relevant MeSH terms:
Multiple Organ Failure
Sepsis
Syndrome
Toxemia
Disease
Infection
Inflammation
Pathologic Processes
Shock
Systemic Inflammatory Response Syndrome
Endothelial Growth Factors
Mitogens
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014