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

This study has been completed.
Sponsor:
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00806325
First received: December 9, 2008
Last updated: May 26, 2010
Last verified: May 2010
  Purpose

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.


Condition
Sepsis
Acute Myeloid Leukemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Factors Associated With the Development of Severe Sepsis in Patients Being Treated for Acute Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • determine the true relationship of hyperglycemia to the development of severe sepsis after chemotherapy for AML [ Time Frame: end of study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

baseline blood sample drawn (2 tablespoons or 30 ml) at the beginning of the study. If subjects experience a fever another blood sample (10 ml up to 2 times) will be drawn at that time.


Enrollment: 120
Study Start Date: November 2007
Study Completion Date: May 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
AML
Adult patients with AML admitted for treatment of the same

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 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

university hospital intensive care unit

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806325

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Naeem A Ali, MD Ohio State University
  More Information

No publications provided

Responsible Party: Naeem Ali/Principal Investigator, The Ohio State University
ClinicalTrials.gov Identifier: NCT00806325     History of Changes
Other Study ID Numbers: 2006C0052
Study First Received: December 9, 2008
Last Updated: May 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Severe Sepsis
Acute Myeloid Leukemia
Sepsis in patients being treated for Acute Myeloid Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Sepsis
Toxemia
Neoplasms by Histologic Type
Neoplasms
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014