Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections

NCT ID: NCT07273071

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2028-02-29

Brief Summary

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.

Conditions

Sepsis; Acute Infection; Severe Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Individualized Treatment Strategy

Group Type: EXPERIMENTAL

Individualized Treatment Strategy

Intervention Type: COMBINATION_PRODUCT

An individualized treatment strategy, where the participant receives up to five of the following: continuous positive airway pressure (CPAP), ketone ester, N-acetylcysteine, iron infusion, hydrocortisone. Each participant's bundle is defined by results from an extended clinical examination.

Standard-of-care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Individualized Treatment Strategy

An individualized treatment strategy, where the participant receives up to five of the following: continuous positive airway pressure (CPAP), ketone ester, N-acetylcysteine, iron infusion, hydrocortisone. Each participant's bundle is defined by results from an extended clinical examination.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theis S. Itenov

OTHER

Sponsor Role: lead

University Hospital Bispebjerg and Frederiksberg

OTHER

Sponsor Role: collaborator

Responsible Party

Theis S. Itenov

Clinical Associate Professor and Specialist Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Emergency Medicine, Copenhagen University Hospital - Bispebjerg and Frederiksberg

Copenhagen, , Denmark

Countries

Denmark

Central Contacts

Frans Wiberg, MD

Role: CONTACT

frans.wiberg@regionh.dk

+4528741294

Theis S Itenov, MD, PhD

Role: CONTACT

theis.skovsgaard.itenov@regionh.dk

Facility Contacts

Jens H Rasmussen, MD

Role: primary

jens.henning.rasmussen@regionh.dk

+4526198801

Other Identifiers

2025-522215-42-00

Identifier Type: CTIS

Identifier Source: secondary_id

2025-522215-42-00

Identifier Type: -

Identifier Source: org_study_id