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Saving Lives by Early Detection and Treatment of Sepsis and Septic Shock by Point of Care Lactate Test in Adults

NCT05108467 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2022-05-27

No results posted yet for this study

Summary

Burden:

The global burden of sepsis is difficult to ascertain, although a recent scientific publication estimated that in 2017 there were 48.9 million cases and 11 million sepsis-related deaths worldwide, which accounted for almost 20% of all global deaths. Recent chart analysis from Dhaka Hospital, icddrb recorded 350 adults with severe sepsis admitted over four years. Among them, 69% of patients progressed to septic shock.

Knowledge gap:

Clinical features of shock due to sepsis and shock due to severe dehydration are very intertwining and often predicament for critical care physicians. If not recognized early and managed promptly, it can lead to septic shock, multiple organ failure, and eventually death. Serum lactate may play a role as the point of care test in differentiating shock due to severe sepsis from shock due to severe dehydration.

Relevance:

Being the largest diarrhoeal disease hospital, the Dhaka Hospital of icddr,b is ideal for researching shock with diarrheal diseases. Even though the onset of sepsis can be acute and poses a short-term mortality burden, it can also cause significant long-term morbidity, requiring treatment and support. Thus, addressing sepsis and severe sepsis by early detection and prompt management should be a comprehensive way to reduce the burden in our community.

Conditions

  • Severe Sepsis With Septic Shock
  • Lactate Blood Increase

Interventions

DIAGNOSTIC_TEST

Point of care Lactate

StatStrip Lactate is a handheld, point-of-care (POC) meter that brings lactate testing directly to the bedside. Lactate measured with blood gas analyzers is problematic for bedside care. Blood gas analyzers require arterial samples, large sample volumes (100-200 μL), and long analysis times (up to 2.5 minutes). In addition, blood gas analyzers are complex to use, stationary, and expensive to purchase and run. StatStrip Lactate testing is as easy as bedside glucose testing. Single-use, pre-calibrated biosensors provide the fastest turnaround time (13 seconds) from the smallest whole blood sample (0.6 μL) with excellent correlation to central laboratory reference methods.

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-21
Primary Completion
2022-08-31
Completion
2022-08-31
FDA Device
Yes

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05108467 on ClinicalTrials.gov