Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections

Phase 4Not Yet RecruitingNCT07273071

Theis S. Itenov300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Sepsis Acute Infection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Days alive and out of hospital at 14 days post-randomization (DAOH-14)

Time frame: Assessed 14 days post-randomization

Secondary Outcomes

Number of participants with one or more serious adverse event within 14 days of randomization

Time frame: Assessed 14 days post-randomization

Days alive and out of hospital at 30 days post-randomization

Time frame: Assessed 30 days post-randomization

All-cause mortality at 14, 30 and 180 days after inclusion

Time frame: Assessed at 14, 30 and 180 days post-randomization

ICU admission within 14 and 30 days of randomization

Time frame: Assessed at 14 and 30 days post-randomization

Hospital length of stay within 14 and 30 days of randomization

Time frame: Assessed at 14 and 30 days post-randomization

Health related quality-of-life at 180 days post-randomization (EQ-5D-5L)

Time frame: Assessed 180 days post-randomization

Duration of antibiotic therapy within 14 and 30 days of randomization

Time frame: Assessed at 14 and 30 days post-randomization

Escalation of antibiotic therapy within 14 and 30 days of randomization

Time frame: Assessed at 14 and 30 days post-randomization

Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts