Diagnosis of Lymphohistiocytic Hemophagocytosis in Intensive Care

NCT07343037 | Recruiting

• 1 other identifier: 9818
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with hepatocellular insufficiency and/or cirrhosis are at risk of developing invasive fungal infections, particularly in critical care settings. In international recommendations, voriconazole is positioned as the first-line treatment for invasive aspergillosis. However, this molecule-and the azole class of antifungals-is associated with frequent hepatic toxicity. Available since 2018, isavuconazole appears to be better tolerated in patients without pre-existing liver dysfunction. The aim of this study is to retrospectively evaluate the validity of the hscore in intensive care and resuscitation patients.

Conditions

Hepatic Insufficiency; Cirrhosis, Liver

Keywords

Hepatic Insufficiency; Cirrhosis, Liver; Lymphohistiocytic hemophagocytosis; Hepatocellular insufficiency; Invasive aspergillosis; Azole antifungals; Liver dysfunction.

Outcome Measures

Primary Outcomes (1)

• hscore

  The HScore adds up points assigned to 9 clinical, biological, and histological criteria: The higher the total score, the greater the likelihood of HLH: Possible total score: 0 to 337: HScore: Probability of HLH: \< 90 points → Very low * 130 points → ≈ 10-20% 168 points → high probability of HL

  Up to 12 months

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

Adult patient admitted to the intensive care unit at Hautepierre Hospital, Strasbourg University Hospital, between January 1, 2014, and December 31, 2024

You may qualify if:

• Adult patient (≥18 years old)
• Patient admitted to the intensive care unit at Hautepierre Hospital, Strasbourg University Hospital, between January 1, 2014, and December 31, 2024
• At least 3 biological signs of HLH:
• ferritin \> 2000 ng/mL
• triglycerides \> 1.5 g/L
• at least one cytopenia (leukocytes ≤ 5000 G/L, platelets ≤ 110 G/L, hemoglobin ≤ 9.2 g/dL).

You may not qualify if:

• Refusal to participate in the study

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Médecine intensive - Réanimation - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Hepatic Insufficiency; Liver Cirrhosis; Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Antonin HUGEROT, MD

CONTACT

33 3 88 12 79 24; antonin.hugerot@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 15, 2026
• Study Start: August 29, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 29, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

FR (1)