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

NCT05108467 | Unknown FDA Device

• 1 other identifier: PR-21097
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Severe Sepsis; Septic Shock; Severe dehydration; POC Lactate; Adult

Outcome Measures

Primary Outcomes (1)

• Change in serum lactate level after completion of hydration in the presence of clinical features of severe sepsis and shock

  First sample (POC-1): Lactate level on enrolment Second sample (POC-2): Lactate level after fluid bolus Expected outcome: Change in level of POC Lactate will be significant in those who do not require inotropes compared to those who require inotropes.

  Within 90 minutes of enrollment

Secondary Outcomes (1)

• Requirement of multiple inotropes

  Within 6 hours of enrollment

Study Arms (2)

Case

Severe sepsis with or without shock

Diagnostic Test: Point of care Lactate

Comparison

Severe dehydration with shock

Diagnostic Test: Point of care Lactate

Interventions

Point of care Lactate DIAGNOSTIC_TEST

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.

Case; Comparison

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

Diarrhea is the entry point for admission to the hospital. Adults presenting with diarrhea and clinically defined and severe sepsis or septic shock recommended by surviving sepsis guidelines supported with our local evidence will be selected as participants in the study. Adults presenting with severe dehydration assessed by the admitting doctor will be enrolled as a comparison group for comparing the role of lactate in both conditions.

You may qualify if:

• Patients have shock due to severe sepsis or septic shock.
• Consent to participate in the study from the patient or his accompanying caregiver.

You may not qualify if:

• Any emergency which might require urgent referral within half an hour of admission.
• Known case of cancer or chemotherapy.
• Life-threatening conditions required cardiopulmonary resuscitation (CPR) on arrival.
• Cardiac shock or anaphylactic origin

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

International Centre for Diarrheal Disease Research, Bangladesh

Dhaka, Outside U.S. and Canada, 1212, Bangladesh

RECRUITING

Related Publications (1)

• Shahrin L, Sarmin M, Parvin I, Al Hasan MM, Nahar MA, Mohammad Sayeem Bin Shahid AS, Shaima SN, Salahuddin Mamun GM, Nasrin S, Ahmed T, Chisti MJ. Point of care lactate for differentiating septic shock from hypovolemic shock in non-ICU settings: a prospective observational study. Lancet Reg Health Southeast Asia. 2024 Oct 21;30:100500. doi: 10.1016/j.lansea.2024.100500. eCollection 2024 Nov.

  PMID: 39502270 DERIVED

MeSH Terms

Conditions

Hyperlactatemia; Sepsis; Shock, Septic; Dehydration

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Shock; Water-Electrolyte Imbalance

Central Study Contacts

M.A Salam Khan

CONTACT

01711428989; salamk@icddrb.org

Study Design

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

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 5, 2021
• Study Start: October 21, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: May 27, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the publication of research findings in peer reviewer journal
• Access Criteria: Communication with the Research Administration of icddrb through the website

Locations

BA (1)