Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections (IMPACT)

Theis S. Itenov

Status and phase: Not yet enrolling; Phase 4

Conditions: Acute Infection; Severe Infection; Sepsis

Treatments: Combination Product: Individualized Treatment Strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT07273071

2025-522215-42-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The goal of the IMPACT trial is to determine whether an individualized treatment strategy, initiated at admission to the Emergency Department, can reduce hospitalizations and improve survival among patients with sepsis. To address this question, we will enroll 300 participants in a randomized controlled trial.

All participants will undergo an extended clinical assessment. Those randomized to the individualized treatment arm may receive up to five targeted interventions, depending on the findings of this assessment.

The targeted interventions are:

1. Continuous positive airway pressure (CPAP) to support breathing and help prevent respiratory problems in participants who show signs of breathing difficulties on ultrasound.
2. Ketone ester, a nutritional supplement, to help support heart function in participants who show signs of heart strain on ultrasound.
3. N-acetylcysteine, an antioxidant treatment, to help protect the liver in participants with early signs of liver stress.
4. Intravenous iron to help prevent or treat anemia in participants who show signs of low iron levels.
5. Hydrocortisone, a steroid, to help stabilize the immune system in participants with signs of immune overactivation.

Participants randomized to the control group will receive standard-of-care according to local clinical guidelines.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years
2. Suspected acute infection within 72 hours of admission, defined as (1) having samples collected for bacterial isolation and/or (2) being initiated on antibiotic therapy
3. Documented clinical suspicion of infection
4. Admitted to the hospital with an expected duration greater than 24 hours
5. Sequential organ failure assessment (SOFA) score ≥2

Exclusion criteria

1. Informed consent following inclusion expected to be unobtainable
2. Inability to read and understand Danish to a degree that allows valid informed consent and completion of trial assessments
3. Pregnant or breastfeeding patients
4. Involuntary admission under the psychiatric law
5. Admitted to hospital or undergone surgery during the 14 days prior to admission
6. Expected initiation of palliative care within 48 hours of randomization
7. Previous randomization into the current trial
8. Admitted to ICU or expected transfer to ICU within 2 hours
9. Previous severe anaphylaxis
10. Any other condition deemed by the investigator to compromise patient safety or trial integrity (e.g., severe coagulopathy, uncontrolled bleeding, diabetic ketoacidosis)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Individualized Treatment Strategy

Experimental group

Treatment:

Combination Product: Individualized Treatment Strategy

Standard-of-care

No Intervention group