The pharmacodynamics of unfractionated heparin and fondaparinux in critically ill patients with severe sepsis.

Dr M Robertson0 sites15 target enrollmentJuly 5, 2006

ConditionsCritically ill patients with severe sepsis.Blood - Other blood disorders

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Critically ill patients with severe sepsis.
Sponsor: Dr M Robertson
Enrollment: 15
Status: Not yet recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 5, 2006

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Dr M Robertson

Eligibility Criteria

Inclusion Criteria

•1\. Known or suspected severe sepsis at the time of screening and meet the inclusion criteria within the following 24 hours. 2\. Diagnosis of severe sepsis, as defined in the recent Australian New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG) study of the incidence of severe sepsis in Australian and New Zealand ICUs \[19]. The criteria for severe sepsis are the presence of systemic inflammatory response syndrome due to infection and the presence of organ dysfunction. a) Patients must have at least 3 of the following 4 criteria: 1\. core temperature ³38oC or £36oC 2\. heart rate ³90 beats/min unless known medical condition associated with increased heart rate or on medication that will prevent increased heart rate. 3\. respiratory rate ³20 breaths/min or PaCO2 (partial pressure of carbon dioxide in arterial blood) 32 mmHg or receiving mechanical ventilation for acute respiratory failure. 4\. white cell count ³12,000/mL or £4,000/mL or a differential count showing \>10% immature neutrophils. PLUS One of the following six criteria must be present to confirm that the episode is due to infection: 1\. polymorphonuclear cells in normally sterile site 2\. culture of pathogenic organism from normally sterile site 3\. chest x\-ray changes consistent with pneumonia 4\. focus of infection identified visually 5\. underlying disease or condition known to be associated with infection (eg ascending cholangitis) 6\. other (reason to be stated) PLUS Organ dysfunction entry criteria as described previously \[19]. 4\. Patients who consent or if the patient is incompetent, the next\-of\-kin who consent, to inclusion in the study.

Exclusion Criteria

•Patients will be excluded if, in the opinion or knowledge of the responsible clinician, any of the following criteria apply: 1\. Patients aged less than 18 years. 2\. Patient is receiving continued full anticoagulation treatment for another reason with either heparin or coumarin agents. 3\. Patients with a contra\-indication to low\-dose heparin including intracranial haemorrhage, active bleeding, or Heparin induced Thrombcytopenia (HIT) in the past 3 months. 4\. Patients with a prior adverse reaction to heparin. 5\. Patients or next\-of\-kin do not consent to inclusion in the study.