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.

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Key information

Conditions

Sepsis Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Infections Inflammation Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

determine the true relationship of hyperglycemia to the development of severe sepsis after chemotherapy for AML

Time frame: end of study

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Acronym: AML

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Dec 10, 2008
Registry last updated: Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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