Status:
COMPLETED
Fluid Resuscitation in Early Septic Shock
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Blood Services
Baxter Healthcare Corporation
Conditions:
Septic Shock
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Severe infection in the intensive care unit is common accounting for about 10% of admissions and has a death rate of approximately 40-50%. It is almost always associated with significant reductions in...
Detailed Description
Background: Severe sepsis and septic shock are the most common causes of mortality among critically ill patients and account for approximately 10% of admissions to the intensive care unit (ICU) and 3%...
Eligibility Criteria
Inclusion
- Eligible patients will meet the following 2 inclusion criteria.
- Refractory Hypotension: The patient has received at least 1 litre of normal saline or ringers lactate crystalloid fluid for hypotension (defined as a systolic blood pressure less than 90 mm Hg, or a systolic blood pressure more than 40 mm Hg below baseline, or a mean arterial blood pressure less than 65 mm Hg) within 8 hours of the first hypotensive event and has refractory hypotension defined by: a) Presence of hypotension OR b) Initiation of a vasopressor agent(s).
- Two or more criteria for the systemic inflammatory response syndrome (SIRS): i) heart rate greater than 90 beats per minute; ii) respiratory rate greater than 20 breathes per minute, or a PaC02 less than 32 mm Hg, or mechanically ventilated; iii) temperature greater than 38 or less than 36 degrees Celsius; iv) or a white blood cell count greater than 12,000 x 109/L or less than 4,000 x 109/L, or more than 10% bands on the differential.
Exclusion
- Clinically apparent other forms of shock including cardiogenic, obstructive (massive pulmonary embolism, cardiac tamponade, tension pneumothorax) or hemorrhagic shock
- Previous admission to ICU with severe sepsis or septic shock during the index hospitalization
- More than 250 mls of colloid fluid (Pentaspan, Voluven, Hextend, or albumin) from the first episode of hypotension
- A known previous severe reaction to albumin
- Burns
- Known cirrhosis
- Traumatic brain injury
- Religious objection to albumin use
- Less than 18 years of age
- Pregnant
- Family or patient not committed to aggressive care
- Currently enrolled in another related interventional study.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00819416
Start Date
February 1 2009
End Date
February 1 2010
Last Update
April 14 2010
Active Locations (6)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
2
Winnipeg Health Sciences Center
Winnipeg, Manitoba, Canada, R3P 0X1
3
Halifax Capital Health Center
Halifax, Nova Scotia, Canada, B3H 2Y9
4
Hamilton General Hospital
Hamilton, Ontario, Canada, L8N 3Z5