Acute Myeloid Leukemia Clinical Trial
Official title:
Clinical Factors Associated With the Development of Severe Sepsis in Patients Being Treated for Acute Myeloid Leukemia
Acute leukemia is a life threatening illness that strikes people of all ages. In addition to
surviving the direct effects of the disease, the treatment of leukemia generally requires
chemotherapy which has its own burden. Infection is one of the most common secondary
problems faced by these patients. Simple infections are common and easily treated with
aggressive antibiotics. However, treated progressive infection leads to loss of vital organ
function and is termed severe sepsis. Severe sepsis is associated with increased risk of
death and the need for specialized care in the intensive care unit.
Besides the appropriate use of antibiotics, little is known about what clinical and patient
factors are associated with the development of severe sepsis. Recent evidence has suggested
that certain practices like frequent transfusion of blood products and control of glucose
levels effects outcome in critically ill patients. In addition, there have been advances in
our knowledge of certain genes that may predispose people to severe infections. It is
possible that these factors are important in people who are not yet critically ill, but are
at risk for the development of severe sepsis.
This observational study will look at genetic, clinical and therapeutic factors that are
associated with the development of severe sepsis. This will help doctors understand what
treatments may be helpful in preventing this serious complication.
Primary hypothesis: Hyperglycemia during inpatient therapy of AML is associated with
increased mortality (fewer hospital free days to Day 60, see below).
- H1a: Hyperglycemia will result in an increased risk of developing clinical signs of
infection (fever).
- H1b: Hyperglycemia will be associated with an increased risk of developing severe
sepsis after the onset of clinical signs of infection (fever).
o H1b1: Hyperglycemia will be associated with the development of acute lung injury
after the onset of signs of infection (fever).
- H1c: Hyperglycemia will be associated with an increased risk of ICU admission.
o H1c1: Hyperglycemia will be associated with an increased risk of ICU admission for
severe sepsis.
- H1d: Hyperglycemia will be associated with an increased risk of death in those subjects
with severe sepsis (fewer hospital free days to Day 60, see below).
Secondary Aim: To investigate whether TSP-1 is important in modulating the course of
sepsis-induced acute lung injury.
Secondary hypothesis: In patients with sepsis, increased levels of functional TSP-1 will be
associated with a lower incidence of and a less severe course of lung injury.
- H2a: In human sepsis, increased TSP-1 levels will be associated with a lower incidence
of lung-injury.
- H2b: In human sepsis, increased TSP-1 levels will be associated with a less severe
course of lung-injury.
- H2c: In human sepsis, patients with the Asn682Ser polymorphism in the TSP-1 gene will
be associated with a higher incidence of lung-injury.
- H2d In human sepsis, patients with the Asn682Ser polymorphism in the TSP-1 gene will be
associated with a more severe course of lung-injury.
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