Hypoxia Inducible Factor 1 Alpha as a Novel Biomarker in Septic Shock

NCT02163473 | Completed

• 1 other identifier: IRB201200142
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine if a chemical marker in the blood, hypoxia-inducible factor (HIF-1 alpha), can be used to predict subject's hospital outcomes when the subject is diagnosed with sepsis. Sepsis is defined as either the presence of pathogenic organisms or their toxins in the blood and tissues. Sepsis is one of the most significant challenges in critical care medicine. The investigators propose that hypoxia-induced expression of HIF-1 alpha will correlate with the clinical features of Sepsis and in the future, HIF-1 alpha may be used as a biomarker in Sepsis.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (2)

• Hypoxia-inducible factor as a predictive biomarker of sepsis.

  Hypoxia-inducible factor will be measured at initial diagnosis (baseline) and 24 hours later in subjects with clinical presentation of sepsis and correlated with lactic acidosis.

  Baseline,

• Hypoxia-inducible factor as a predictive biomarker of sepsis

  Hypoxia-inducible factor will be measured at initial diagnosis (baseline) and 24 hours later in subjects with clinical presentation of sepsis and correlated with lactic acidosis.

  24 hours

Secondary Outcomes (1)

• Evaluate the role of HIF complex as biomarker and its correlation with "Survive the Sepsis Campaign 2012" gold standard septic shock severity and morbidity/mortality predictors.

  28 days

Study Arms (2)

Septic patients

Blood Draw Biological samples: The investigators will collect blood and compare the expression of HIF complex in 3 distinct ways: between patients and controls, within the same patient in a time-dependent fashion, and between different patients.

Procedure: Septic patients

Healthy Control

The investigators will collect blood and compare the expression of HIF complex in 3 distinct ways: between patients and controls, within the same patient in a time-dependent fashion, and between different patients.

Procedure: Healthy Control

Interventions

Septic patients PROCEDURE

The investigators will draw two sets of blood samples. One at baseline, 10 mL, and another, 24 hours later, 10 mL, for a total of 20 mL.

Septic patients

Healthy Control PROCEDURE

The investigators will draw 10 mL, once, during baseline for a total of 10 mL among the healthy control group.

Healthy Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal healthy controls recruited from the community. Subjects with sepsis admitted to the University of Florida Hospital.

You may qualify if:

• Age 18 ≤ 80 years
• Negative pregnancy test for women of childbearing potential
• Meets two or more of Systemic Inflammatory Response System (SIRS) criteria (tachypnea, tachycardia, hypo/hyperthermia, leukopenia/leukocytosis)
• Evidence of tissue hypo-perfusion, or organ dysfunction by any of the following
• Sepsis induced hypotension with systolic blood pressure \<90
• Lactate above 1.5 mmol/Liter
• Urine output below 0.5 mL/kg/hr for more than 2 hours despite adequate fluid resuscitation
• Tissue hypoxia
• Bilirubin \> 2 mg/dl in absence of liver cirrhosis
• Creatinine (CR)\> 2.0 mg/dL, Acute Kidney Injury as evident by CR increase by 0.5 mg/dL from baseline
• Platelet count \< 100,000
• Coagulopathy with international normalized ratio (INR) \>1.5
• Age and gender-matched to sepsis patients
• Negative pregnancy test in women of childbearing potential
• Never smoker (\<1 pack year history)

You may not qualify if:

• History of Malignancy, including carcinoma during the preceding 5 years.
• Recent surgery, within 48 hours, or anticipated surgery within 24 hours
• Contraindication for neck/chest central venous line
• Transfer from another institution
• History of cirrhosis
• Transplant recipient
• Known HIV
• Use of ≥ 15 mg prednisone daily or equivalent
• Severe anemia: hematocrit ≤ 20
• History of Malignancy, including carcinoma during the preceding 5 years.
• Taking any prescription medications, other than any type of prescribed hormonal birth control.
• Current smoking history and/or \> 1 pack year history
• Current use (within the last week) anti-inflammatory medications, such as aspirin, ibuprofen, naproxen and/or prednisone

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wael Nasser, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: June 13, 2014
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 13, 2016

Record last verified: 2016-10

Locations

US (1)