NCT00908635

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

May 27, 2009

Status Verified

May 1, 2009

Enrollment Period

2.1 years

First QC Date

May 25, 2009

Last Update Submit

May 26, 2009

Conditions

Keywords

sepsisorgan failure

Outcome Measures

Primary Outcomes (1)

  • mortality

    in hospital mortality

Secondary Outcomes (1)

  • organ failure

    In ICU stay

Study Arms (2)

survivor

survivors of patients

fatalities

non-survivors of patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients admitted to ICU due to sepsis

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Related Publications (1)

  • Lin SM, Wang YM, Lin HC, Lee KY, Huang CD, Liu CY, Wang CH, Kuo HP. Serum thrombomodulin level relates to the clinical course of disseminated intravascular coagulation, multiorgan dysfunction syndrome, and mortality in patients with sepsis. Crit Care Med. 2008 Mar;36(3):683-9. doi: 10.1097/CCM.0B013E31816537D8.

    PMID: 18431261BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

SepsisMultiple Organ Failure

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Shu-Min Lin, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 25, 2009

First Posted

May 27, 2009

Study Start

July 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

May 27, 2009

Record last verified: 2009-05

Locations