Clinical Factors Associated With the Development of Severe Sepsis in Patients Being Treated for Acute Myeloid Leukemia
18 Years
N/A
Both
Sepsis, Acute Myeloid Leukemia
Trial Information
Clinical Factors Associated With the Development of Severe Sepsis in Patients Being Treated for Acute Myeloid Leukemia
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.
Inclusion Criteria
Inclusion criteria:
- Diagnosis of acute myeloid leukemia
- Age ≥ 18 years of age
- Plans to receive chemotherapy as an inpatient and remain inpatient until hematologic
recovery as determined by the primary treating physician
Exclusion criteria:
- Subject is unlikely to survive > 3 months with treatment
- Current diagnosis of severe sepsis
- Subject or surrogate is unable to give informed consent
- Subject is incarcerated
- Patient's family, physician, or both not in favor of endotracheal intubation or
mechanical ventilation for any length of time or the presence of an advanced
directive to withhold the same.
- Subject currently requiring mechanical ventilation
- Subject with current diagnosis of acute lung injury or ARDS (bilateral infiltrates on
chest X-ray and PF ratio< 300 with no evidence of left atrial hypertension)
- Subject has received chemotherapy for the treatment of AML > 96 hours ago.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
determine the true relationship of hyperglycemia to the development of severe sepsis after chemotherapy for AML
Outcome Time Frame:
end of study
Safety Issue:
No
Principal Investigator
Naeem A Ali, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ohio State University
Authority:
United States: Institutional Review Board
Study ID:
2006C0052
NCT ID:
NCT00806325
Start Date:
November 2007
Completion Date:
May 2010
Related Keywords:
- Sepsis
- Acute Myeloid Leukemia
- Severe Sepsis
- Acute Myeloid Leukemia
- Sepsis in patients being treated for Acute Myeloid Leukemia
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Sepsis
- Toxemia
Name | Location |
|---|---|
| The Ohio State University | Columbus, Ohio 43210 |
