İntensive Care Sepsis Prevelance in Turkey (INSEP-TURK)

NCT07283588 | Active Not Recruiting

• 1 other identifier: 2025-354
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis is a life-threatening condition characterized by a dysregulated host response to infection, leading to tissue damage, multiple organ dysfunction (MODS), disseminated intravascular coagulation (DIC), and high mortality. Despite its global significance, robust epidemiological data from low- and middle-income countries, including Turkey, remain limited. This multicenter, two-timepoint point-prevalence study aims to determine the prevalence of sepsis and septic shock in adult intensive care units (ICUs) across Turkey and to evaluate associated clinical outcomes.The study will be conducted between September 2025 and January 2026 in adult ICUs nationwide. Sepsis and septic shock will be defined according to the 2021 Surviving Sepsis Campaign Guidelines. Detailed data will be collected on participating ICUs, clinicians, patient demographics, comorbidities, infection characteristics, organ dysfunction, laboratory findings, and treatments. Patients will be followed for 30 days to assess ICU length of stay, discharge status, mortality, and ventilator- and vasopressor-free days.The primary objective is to determine the point prevalence of sepsis and septic shock in Turkish ICUs. The secondary objective is to evaluate 30-day mortality among patients with sepsis and septic shock. The findings are expected to provide crucial epidemiological insights and help improve sepsis management strategies in Turkey.

Conditions

Sepsis; Septic Shock Point Prevalence

Keywords

Prevalence of Septic Shock; TÜRKİYE; POINT PREVALENCE; sepsis

Outcome Measures

Primary Outcomes (1)

• Point-prevalence of sepsis and septic shock in adult ICU patients in Turkey

  The proportion of adult patients in participating ICUs who meet the 2021 Surviving Sepsis Campaign criteria for sepsis or septic shock on the study day.

  On the study day (two time points: September 2025 and January 2026)

Secondary Outcomes (1)

• 30-day mortality among ICU patients with sepsis or septic shock

  30 days post-study day

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

The study will be conducted in adult intensive care units across Turkey, including patients aged 18 years and older.

You may qualify if:

• The study will be conducted in adult intensive care units across Turkey, including patients aged 18 years and older.

You may not qualify if:

• Individuals under 18 years of age
• Individuals who do not consent to participate in the study

Sponsors & Collaborators

• Gulhane Training and Research Hospital: lead

Study Sites (1)

Gülhane Training and Research Hospital

Ankara, Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (4)

• Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.

  PMID: 34605781 RESULT

• Fleischmann-Struzek C, Mellhammar L, Rose N, Cassini A, Rudd KE, Schlattmann P, Allegranzi B, Reinhart K. Incidence and mortality of hospital- and ICU-treated sepsis: results from an updated and expanded systematic review and meta-analysis. Intensive Care Med. 2020 Aug;46(8):1552-1562. doi: 10.1007/s00134-020-06151-x. Epub 2020 Jun 22.

  PMID: 32572531 RESULT

• Connelly-Smith L, Alquist CR, Aqui NA, Hofmann JC, Klingel R, Onwuemene OA, Patriquin CJ, Pham HP, Sanchez AP, Schneiderman J, Witt V, Zantek ND, Dunbar NM. Guidelines on the Use of Therapeutic Apheresis in Clinical Practice - Evidence-Based Approach from the Writing Committee of the American Society for Apheresis: The Ninth Special Issue. J Clin Apher. 2023 Apr;38(2):77-278. doi: 10.1002/jca.22043.

  PMID: 37017433 RESULT

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 RESULT

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 30 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: study director

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 16, 2025
• Study Start: December 16, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-12

Locations

TU (1)