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Clinical Factors Associated With the Development of Severe Sepsis in Patients Being Treated for Acute Myeloid Leukemia


N/A
18 Years
N/A
Not Enrolling
Both
Sepsis, Acute Myeloid Leukemia

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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 UniversityColumbus, Ohio  43210