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CIHR Clinical
Trials
VASST: A Randomized Controlled Trial of Vasopressin vs.
Norepinephrine in Septic
Shock
Background:
Ten thousand Canadians die every year from septic shock, a condition characterized
by failure of the circulation due to infection. Therapy consists of treatment
of the underlying infection (with antibiotics and surgery when necessary)
and stabilization of the blood pressure with adrenaline-like agents. Unfortunately,
around 60% of people with septic shock die either in the early stages because
the blood pressure can’t be stabilized, or in the weeks to follow due
to step-wise failure of vital organs such as the brain, kidneys, liver, bone
marrow and heart.
Vasopressin is a very important hormone produced by the brain in response to
shock. Unfortunately, people who have advanced septic shock have a deficiency
of vasopressin and therefore have lost this important defense. Researchers
have shown that infusion of a very low dose of this hormone can restore blood
pressure. Whether low-dose vasopressin infusion can reduce organ failure and
improve survival is not known.
Methods and Trial Design:
This is an international multi-centred triple-blind, randomized controlled
trial of vasopressin vs. norepinephrine in septic shock designed to determine
the effectiveness of vasopressin compared to norepinephrine in increasing 28-day
and 90-day survival. Trial design is based on administration of a low –dose
infusion of vasopressin (“hormone-replacement” dose) to patients
with established septic shock. This trial has been rigorously designed to find
out whether vasopressin will improve the circulation, reduce organ failure,
and most importantly, whether it will save lives.
This study is novel because it is the first RCT of vasopressin
vs. norepinephrine in septic shock to examine outcomes. This study
extends previous studies, which showed physiological benefits of
vasopressin compared to conventional vasopressors. However, none
of the previous studies were designed or powered to determine the
effects on mortality or organ dysfunction. This study will extend
our understanding of the role of vasopressin deficiency in septic
shock and will show whether vasopressin improves therapy of septic
shock.
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