Clinical Trials Logo

Clinical Trial Summary

This project will evaluate the usefulness of Monocyte Distribution Width (MDW) for the diagnosis of blood culture positivity (BSI) in patients in the Emergency Department (ED) and reevaluate the usefulness of MDW in patients with BSI and sepsis. Consequently, if MDW indicate a high likelihood of bacteremia antibiotic management in patients with suspected bacterial infections will be changed and aid appropriate antibiotic administration.


Clinical Trial Description

BIOMARKERS for Sepsis and Infection should address important clinical aspects such as 1. Rapid diagnosis of invasive infections contributing to organ dysfunction; 2. Provide information regarding antibiotic susceptibility and 3. Distinguish infection mediated organ dysfunction from non-infectious sepsis mimics. Review of MDW values for ED patients who have positive blood cultures The gold standard for the diagnosis of bloodstream infections is positive blood cultures. Not all patients with sepsis have positive blood cultures, however patients with blood stream infections and end-organ dysfunction are septic and need to be treated with antibiotics. Two definitions of sepsis currently are used. The sepsis-2 definitions [1,2] are based on a confirmed or suspected infectious source, a systemic response with two or more abnormal systemic inflammatory response syndrome criteria such as hyper or hypothermia, tachycardia, tachypnea and leukopenia or leukocytosis or bandemia and signs of at least one new end organ dysfunction. There is a differentiation between different degrees of disease severity between sepsis, severe sepsis and septic shock. Each of these degrees of illness severity are associated with different morbidity and mortality. The sepsis-3 definition [3] state that sepsis is the bodies response to an infectious agent. The response is assessed using a quick SOFA score (qSOFA) assessment based on tachypnea of equal or greater than 22 breath, systolic hypotension of equal or less than 100 mmHg and changes in mentation measured by a Glasgow Coma Score (GCS) of less than 15 along with the requirement of a new onset of organ dysfunction as measured by a SOFA score of equal or greater than 2.[4] Sepsis-3 definition distinguish between sepsis and septic shock only. Septic shock is only present if a patient has 2 or more qSOFA criteria, requires the use of a vasoactive agent to maintain a mean arterial blood pressure of 70 mmHg AND if the lactate is greater than 2 mg/dL. Patients which do not have a qSOFA score of greater than 2 or a SOFA score of less than 2 are considered not septic and as having only a local infection. Both definitions have the requirement for a proven or suspected infection. Source identification is important, however not always successful. The most common site of infection is the lung. This infection is most commonly viral or bacterial. The second most common site of infection is the genitourinary tract followed by blood stream infections. The diagnosis of blood stream infections (BSI) can be affected by a variety of factors including the collection technique to avoid contamination, the amount of blood volume collected, the timing of collection among other factors. Specifically, the early recognition of blood culture positivity and appropriate early source control are essential for successful treatment of patients with signs of a systemic response to the blood stream infection and end-organ dysfunction. Delay in recognition of blood culture positivity can lead to treatment delays along with possible disease progression. Studies evaluated the usefulness of monocyte distribution width (MDW) for the assessment of emergency department patients with sepsis. It has been observed that monocyte activation in response to bacteremia leads to increased monocyte size. [5] MDW reflects a measure of a change in the size distribution of circulating monocytes. MDW has been evaluated for the aid of sepsis based on the definitions above. [6] The study by Crouser showed that the detection diagnosis of sepsis within 12 hours of ED presentation was aided when MDW was added. Similar, Polili et al found that the addition of MDW to the routine White Blood Cell (WBC) counts aids sepsis diagnosis and may be more useful than procalcitonin. [7] It has not yet clearly established that MDW are elevated in bloodstream infections (BSI). BSI are diagnosed using blood cultures as gold standard for diagnosis. Blood cultures have a high sensitivity and specificity.[8] Up to thirty forty percent of septic shock patients will be blood culture positive and up to 25-30% negative for any type of culture. However, the diagnosis can take time delaying initiation of appropriate treatment. Additionally, in up to 50 % of cases BSI may be present without blood culture positivity due to the presence of uncultivable organisms or antibiotic treatment started prior to sampling.[9] MDW may be useful in not only aiding the diagnosis of sepsis but also in the expedited diagnosis of BSI. This project will evaluate the usefulness of MDW for the diagnosis of blood culture positivity (BSI) in patients in the ED and reevaluate the usefulness of MDW in patients with BSI and sepsis. Consequently, if MDW indicate a high likelihood of bacteremia; antibiotic management in patients with suspected bacterial infections will be changed and aid appropriate antibiotic administration. On the other hand, a negative MDW test in the ED without additional risk factors or signs of infection (ie. Urinary tract, pneumonia, skin) or suspected severe sepsis or septic shock, patients may be treated supportively without use of antibiotics in the appropriate clinical setting. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05296590
Study type Observational
Source Henry Ford Health System
Contact
Status Active, not recruiting
Phase
Start date July 1, 2021
Completion date June 2026

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05095324 - The Biomarker Prediction Model of Septic Risk in Infected Patients
Completed NCT02714595 - Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens Phase 3
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Completed NCT02867267 - The Efficacy and Safety of Ta1 for Sepsis Phase 3
Completed NCT04804306 - Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
Recruiting NCT05578196 - Fecal Microbial Transplantation in Critically Ill Patients With Severe Infections. N/A
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Completed NCT04332861 - Evaluation of Infection in Obstructing Urolithiasis
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Enrolling by invitation NCT05052203 - Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Completed NCT03258684 - Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock N/A
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed NCT05018546 - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery N/A
Completed NCT03295825 - Heparin Binding Protein in Early Sepsis Diagnosis N/A
Not yet recruiting NCT06045130 - PUFAs in Preterm Infants
Not yet recruiting NCT05361135 - 18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3