NCT01604551

Brief Summary

Microparticles (MPs) result from plasma cell membrane remodeling and shedding after cell stimulation or apoptosis. MPs are know recognized as a pool of bioactive messengers with emerging role in pathophysiology of immune and cardiovascular diseases. MPs have been characterized during septic shock and may contribute to dissemination of pro-inflammatory and procoagulant mediators. This is a prospective observational study of circulating MPs and blood coagulation in 100 septic shock patients admitted in 3 tertiary hospitals medical ICU at baseline (D1), D2, D3, D4 and D7.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2003

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

May 1, 2003

Completed
8.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
Last Updated

June 1, 2012

Status Verified

May 1, 2012

First QC Date

May 21, 2012

Last Update Submit

May 31, 2012

Conditions

Septic Shock

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with septic shock

You may qualify if:

  • Septic shock
  • Informed consent

You may not qualify if:

  • Class IV heart failure
  • Child-Plugh grade C cirrhosis
  • Cancer under active treatment
  • BMI\>35 kg/m²
  • Moribund patient
  • DNR decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Service Réanimation Médicale et Médecine Hyperbare, CHU

Angers, 49933, France

Location

Centre Hospitalier

Mulhouse, 68070, France

Location

Service de Réanimation Médicale, Nouvel Hôpital Civil, Hôpitaux Universitaires

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Xavier DELABRANCHE, MD

    Service de Réanimation Médicale, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2012

First Posted

May 23, 2012

Study Start

May 1, 2003

Study Completion

December 1, 2011

Last Updated

June 1, 2012

Record last verified: 2012-05

Locations

FR(3)