FIRE - Flap Infection Risk Evaluation with an Intensive Care Infection Score

FIRE - Flap Infection Risk Evaluation with an Intensive Care Infection Score - FIRE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036907

Enrollment

Registered

2025-06-11

Start date

2025-07-01

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A41

Interventions

Group 1: Daily collection of differential blood counts after oral and maxillofacial plastic flap surgery and during the inpatient stay in the intensive care unit, as well as simultaneous measurement o

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients undergoing oral and maxillofacial flap surgery

Exclusion criteria

Exclusion criteria: Hereditary erythrocyte disorders, e.g., sickle cell disease, hereditary spherocytosis, and hereditary hemoglobinopathies

Design outcomes

Primary

Measure	Time frame
Daily differential blood counts after oral and maxillofacial plastic flap surgery and during the inpatient stay in the intensive care unit, as well as simultaneous measurement of Hepcidin, "Ret-He" and "Delta-He" (iron parameters), and assessment of the "ICIS score" as a potential decision aid for sepsis diagnosis.	—

Secondary

Measure	Time frame
Patient characteristics (age, gender, weight, height, body surface area, ASA classification) Pre-existing conditions (especially EUROSCORE, diabetes mellitus, arterial hypertension, COPD, anemia, peripheral arterial disease (pAVK), heart failure/NYHA classification) Prior surgeries Long-term medication Other medical history (allergies, alcohol and nicotine consumption, drug abuse, etc.) Admission diagnosis Clinical routine laboratory tests: inflammation markers (leukocytes, CRP, PCT), erythrocytes, hemoglobin, hematocrit, MCH, MCV, MCHC, platelets, Quick, PTT, creatinine, urea, cystatin C, GOT, GPT, GGT, AP, LDH, lactate, total protein, albumin, sodium, potassium, calcium, magnesium, chloride, TnT, TnI, CK, CK-MB, BNP Additional parameters of the differential blood count including IPF (immature platelets) and reticulocyte hemoglobin IPF is given as a percentage of total platelet concentration (IPF%) and as an absolute concentration of immature platelets (IPF#), as well as the proportion of high-fluorescent, very immature platelets, H-IPF (research parameter*). Number of mature neutrophils, number of immature neutrophils, number of antibody-secreting cells, detection of neutrophil and monocyte/macrophage activation Hemodynamics: systolic arterial blood pressure (min/max), diastolic arterial blood pressure (min/max), mean arterial pressure (min/max), central venous pressure (min/max), heart rate (min/max) Inflammatory parameters (IL-6, IL-10) Ventilation parameters (FiO2, respiratory rate, Pmax, Pinsp, PEEP) Arterial/central venous blood gas analyses (BGAs): pH, hemoglobin (Hb), pCO2, pO2, SaO2, HCO3, base excess (BE), lactate Fluid balance: intake (crystalloids, colloids, blood transfusions) and output (blood loss, urine volume) Catecholamine therapy Medication for sedation and analgesia Sepsis focus & pathogens and antibiotic therapy 30-day survival Length of stay in the intensive care unit and hospital	—

Measure

Time frame

Patient characteristics (age, gender, weight, height, body surface area, ASA classification) Pre-existing conditions (especially EUROSCORE, diabetes mellitus, arterial hypertension, COPD, anemia, peripheral arterial disease (pAVK), heart failure/NYHA classification) Prior surgeries Long-term medication Other medical history (allergies, alcohol and nicotine consumption, drug abuse, etc.) Admission diagnosis Clinical routine laboratory tests: inflammation markers (leukocytes, CRP, PCT), erythrocytes, hemoglobin, hematocrit, MCH, MCV, MCHC, platelets, Quick, PTT, creatinine, urea, cystatin C, GOT, GPT, GGT, AP, LDH, lactate, total protein, albumin, sodium, potassium, calcium, magnesium, chloride, TnT, TnI, CK, CK-MB, BNP Additional parameters of the differential blood count including IPF (immature platelets) and reticulocyte hemoglobin IPF is given as a percentage of total platelet concentration (IPF%) and as an absolute concentration of immature platelets (IPF#), as well as the proportion of high-fluorescent, very immature platelets, H-IPF (research parameter*). Number of mature neutrophils, number of immature neutrophils, number of antibody-secreting cells, detection of neutrophil and monocyte/macrophage activation Hemodynamics: systolic arterial blood pressure (min/max), diastolic arterial blood pressure (min/max), mean arterial pressure (min/max), central venous pressure (min/max), heart rate (min/max) Inflammatory parameters (IL-6, IL-10) Ventilation parameters (FiO2, respiratory rate, Pmax, Pinsp, PEEP) Arterial/central venous blood gas analyses (BGAs): pH, hemoglobin (Hb), pCO2, pO2, SaO2, HCO3, base excess (BE), lactate Fluid balance: intake (crystalloids, colloids, blood transfusions) and output (blood loss, urine volume) Catecholamine therapy Medication for sedation and analgesia Sepsis focus & pathogens and antibiotic therapy 30-day survival Length of stay in the intensive care unit and hospital

—

Countries

Germany

Contacts

Public ContactDania Fischer

Universitätsklinikum Heidelberg

dania.fischer@med.uni-heidelberg.de+4962215636166

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026