Ubiquinol (Reduced COQ10) for Patients With Sepsis

Severe sepsis and septic shock are the cause of significant morbidity and mortality
worldwide. An estimated 751,000 (3 per 1,000 population) cases of severe sepsis occur in the
United States each year, resulting in approximately 215,000 deaths. Septic shock is
characterized by hypotension, hypermetabolic state, lactic acidosis, and potentially death.
In addition, the economic burden on the health care system for patients suffering from
severe sepsis is striking. Weycker et al. report that patients suffering from severe sepsis
will require an average of $45,000 dollars of medical care cost on their index admission and
up to $78,500 dollars in the first year post-diagnosis. These figures rival such entities as
acute myocardial infarction, trauma, and stroke. Whereas a significant amount of research
and therapeutic interventions have been focused on the "early hours" of diseases such as
acute myocardial infarction, stroke, and trauma, less attention has been given to the
initial stages of severe sepsis and septic shock.

Coenzyme Q10 (CoQ10) is a safe and feasible medicinal intervention with a strong scientific
rationale for use in septic shock. CoQ10 is a key component of the mitochondria, serving as
an electron transport medium between complex I/II and complex III. A lesion at this point in
the electron transport chain results in an inadequate production of ATP for the cell. In
septic shock, CoQ10 levels are profoundly decreased and therefore production of energy may
be compromised. CoQ10 has two essential roles in critically ill patients with sepsis: 1)
production of ATP and 2) reduction of free oxygen radicals. CoQ10's key role in the electron
transport chain may prevent the well-described mitochondrial dysfunction that occurs in
patients with septic shock. Thus, these two essential roles form the pathophysiological
basis for this proposed study.

In the following proposal, the investigators plan to perform a pilot study to evaluate the
capacity for ubiquinol (reduced form of COQ10) to attenuate mitochondrial injury, to
attenuate inflammation/vascular endothelial injury, the effect on the human metabolome, and
to be absorbed. The overall goal of this line of research will be to determine if CoQ10 will
attenuate oxidative injury and improve mitochondrial function leading to overall improved
outcome in patients suffering from septic shock. In order to achieve this long-term goal,
the investigators propose this pilot and feasibility trial to determine CoQ10 absorption in
critical illness, capacity to mitigate inflammatory injury and oxidative injury, and ability
to maintain mitochondrial electron transport chain functionality. This pilot study will also
provide key feasibility data on blinding and other logistical issues necessary for execution
of a larger-scale investigation.

Inclusion Criteria:

- Over 18 years old

- Suspected or confirmed infection

- Presence of 2 or more systemic inflammatory response syndrome (SIRS) criteria

- Admission to the ICU

Exclusion Criteria:

- Under 18 years old

- Current CoQ10 supplementation

- Unable to receive enteral medications

- Would need a nasogastric or orogastric tube solely for the purposes of the study

- Pregnancy, incarceration, mentally disability

- Patient confirmed Comfort measures only, Do not resuscitate (DNR) and/or Do not
intubate. Patients with DNR but intubated and being provided full care are eligible