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

January 30, 2017 updated by: Naeem Ali, MD, Ohio State University

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

university hospital intensive care unit

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
AML
Adult patients with AML admitted for treatment of the same

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
determine the true relationship of hyperglycemia to the development of severe sepsis after chemotherapy for AML
Time Frame: end of study
end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Investigators

  • Principal Investigator: Naeem A Ali, MD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

December 9, 2008

First Submitted That Met QC Criteria

December 9, 2008

First Posted (Estimate)

December 10, 2008

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006C0052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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