Status:
COMPLETED
Clinical Factors Associated With the Development of Severe Sepsis in Patients Being Treated for Acute Myeloid Leukemia
Lead Sponsor:
Ohio State University
Conditions:
Sepsis
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
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 whic...
Detailed Description
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 increa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00806325
Start Date
November 1 2007
End Date
May 1 2010
Last Update
February 1 2017
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43210