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

NCT00806325 | Completed

• 1 other identifier: 2006C0052
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Sepsis; Acute Myeloid Leukemia

Keywords

Severe Sepsis; Acute Myeloid Leukemia; Sepsis in patients being treated for Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

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

  end of study

Study Arms (1)

AML

Adult patients with AML admitted for treatment of the same

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

university hospital intensive care unit

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

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.

MeSH Terms

Conditions

Sepsis; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

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

Study Officials

• Naeem A Ali, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 10, 2008
• Study Start: November 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 1, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)