We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00908635
Recruitment Status : Unknown
Verified May 2009 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : May 27, 2009
Last Update Posted : May 27, 2009
Sponsor:
Information provided by:
Chang Gung Memorial Hospital

Brief Summary:
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 or disease
Sepsis Multiple Organ Dysfunction Syndrome

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.


Study Type : Observational
Estimated Enrollment : 120 participants
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
Study Start Date : July 2008
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Group/Cohort
survivor
survivors of patients
fatalities
non-survivors of patients



Primary Outcome Measures :
  1. mortality [ Time Frame: in hospital mortality ]

Secondary Outcome Measures :
  1. organ failure [ Time Frame: In ICU stay ]

Biospecimen Retention:   Samples Without DNA
whole blood


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Shu-Min Lin, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00908635     History of Changes
Other Study ID Numbers: 96-1483B
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: May 27, 2009
Last Verified: May 2009

Keywords provided by Chang Gung Memorial Hospital:
sepsis
organ failure

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