Fluid Resuscitation in Early Septic Shock

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 blood pressure. Administration of fluid often in large volumes is essential to normalize blood pressure and prevent failure of organs and death. Two common classes of fluid solutions are crystalloid fluids (salt based, normal saline) and colloid fluids (protein based, albumin). Due to its properties, the albumin fluid may remain in the vascular space better than the normal saline solution. Hence, there may be faster attainment of normal blood pressure as well as a reduction in failed organs and death. Preliminary clinical trial data suggests a potential for benefit with albumin in this setting but these findings require confirmation in a large clinical trial.

There are few data to explain how albumin may exert its protective effects and lead to better outcomes for patients with severe infections. We will conduct a clinical study that will examine potential biological mechanisms for albumin's protective effects in 50 patients across 6 Canadian academic hospitals. We will also examine our ability to successfully recruit patients into this trial.

This study will provide information that will help to understand the biological mechanisms of albumin in severe infection. The information gained will guide the investigative team for future fluid related mechanistic questions. The study will also provide essential information that will aid in the design and conduct of the future large clinical trial that will examine death as its primary outcome.

Conditions

• Septic Shock
• Sepsis
• Severe Sepsis

Interventions

DRUG

5% albumin

5% albumin for the first 7 days of care in the ICU

DRUG

Normal Saline

Normal Saline for the first 7 days of care in the ICU

Sponsors & Collaborators

• Canadian Blood Services

  collaborator OTHER

• Baxter Healthcare Corporation

  collaborator INDUSTRY

• Ottawa Hospital Research Institute

  lead OTHER

Principal Investigators

• Lauralyn A McIntyre, MD · Ottawa Hospital Research Institute

• Alan Tinmouth, MD · Ottawa Hospital Research Institute

• Alison Fox Robichaud, MD · Hamilton Health Sciences Corporation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-02-28

Primary Completion

2009-10-31

Completion

2010-02-28

Countries

• Canada

Study Locations