Hemodynamic Phenotype-Based,Capillary Refill Time-Targeted Resuscitation In Early Septic Shock:ANDROMEDA-SHOCK-2

NCT06062303 | Recruiting

• 1 other identifier: APHP220794
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Over-resuscitation including fluid overload has been associated with increased morbidity (prolonged duration of organ failure) and mortality in septic shock. "One-size-fits-all" resuscitation strategies may increase septic shock mortality. However, clinical studies on individualized resuscitation are lacking. Hemodynamic phenotyping may allow to individualize septic shock resuscitation. The ANDROMEDA-SHOCK trial found that a simple clinical and bedside CRT-targeted resuscitation reduces organ dysfunction and 28-day mortality in septic shock. The current study will examine the hypothesis that a CRT-targeted resuscitation based on hemodynamic phenotyping considering within an decision tree usual bedside clinical parameters such as pulse pressure, diastolic blood pressure, fluid responsiveness and cardiac performance can further decrease mortality in septic shock as compared to usual care.

Conditions

Intensive Care Unit Acquired Weakness; Shock, Septic

Outcome Measures

Primary Outcomes (1)

• A composite of all cause 28-days mortality plus time to cessation of vital support and length of hospital stay

  A hierarchical composite of all cause mortality within 28 days, time to cessation of vital support (truncated at 28 days) and length of hospital stay (truncated at 28 days).

  28 days

Secondary Outcomes (3)

• All-cause mortality within 28 days

  28 days

• Vital support free days

  28 days

• Length of hospital stay

  28 days

Other Outcomes (19)

• Length of ICU stay

  28 days

• Time to cessation of vasopressor support

  28 days

• Time to cessation of mechanical ventilation

  28 days

Study Arms (2)

Compartor arm

NO INTERVENTION

\- Patients allocated to the usual care group will be managed by the clinical staff according to usual practice at their sites including decisions about hemodynamic and perfusion monitoring, and all treatments, but should follow general recommendations of the Surviving Sepsis Campaign to avoid extremes of clinical practice. This includes basic hemodynamic targets such as a MAP \>65 mmHg, HR (heart rate) \<120 beats per minute (BPM), arterial oxygen saturation (SaO2) \>94%, Hb \> 7 gr/dl, and the use of NE as the first vasopressor and crystalloids as the fluid of choice.

Capillary-refill time and phenotyping group

ACTIVE COMPARATOR

Patients w/normal baseline CRT will be periodically monitored. Patients with abnormal CRT and septic shock will be categorized according to pulse pressure (PP). If \<40 mmHg, will go to fluid responsiveness (FR) assessment. FR (-) patients will undergo cardiac echo to rule out significant dysfunction. Fluid boluses will be administered in 30 min intervals and repeated as needed if CRT is still abnormal. Patients with PP ≥40 mmHg will proceed according to diastolic pressure (DAP). If ≥50 mmHg will move to FR assessment. If \<50 mmHg NE will be increased for MAP \>65 mmHg and DAP ≥50 mmHg w/CRT assessed 1 h after. NE will be increased in 0.1 mcg/k/m increments up to 0.5 mcg/k/m. If CRT is normal, patients will proceed to periodic monitoring. Patients with persistent abnormal CRT or that reached NE safety limit will proceed directly to echo. Patients that correct CRT with first tier interventions will not be subjected to obligatory echo but will just proceed to periodic monitoring.

Other: Usual care (UC)

Interventions

Usual care (UC) OTHER

\- Patients allocated to the UC group will be managed by the clinical staff according to usual practice at their sites including decisions about hemodynamic and perfusion monitoring, and all treatments, but should follow general recommendations of the Surviving Sepsis Campaign to avoid extremes of clinical practice. This includes basic hemodynamic targets such as a MAP \>65 mmHg, heart rate (HR) \<120 beats per minute (BPM), arterial oxygen saturation (SaO2) \>94%, Hb \> 7 gr/dl, and the use of NE as the first vasopressor and crystalloids as the fluid of choice.

Capillary-refill time and phenotyping group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive adult patients (≥ 18 years)
• Patients with septic shock according to Sepsis-3 consensus conference. In short, septic shock is defined as suspected or confirmed infection, plus hyperlactatemia and NE requirements due to persistent hypotension, after a fluid load of at least 1000mL in 1h
• Patient and/or relative informed and having signed the information and consent form for participation in the study

You may not qualify if:

• More than 4 hours since septic shock diagnosis,
• Anticipated surgery or acute hemodialysis procedure to start during the 6h intervention period
• Active bleeding,
• Do not resuscitate status,
• Child B-C Cirrhosis
• Underlying disease process with a life expectancy \< 90 days and/or the attending clinician deems aggressive resuscitation unsuitable
• Refractory shock (high risk of death within 24h)
• Pregnancy
• Concomitant severe acute respiratory distress syndrome
• Patients in whom CRT cannot be accurately assessed
• Non-affiliation to a social security scheme or to another social protection scheme
• Patient on AME (state medical aid) (unless exemption from affiliation
• Patient under legal protection (guardianship, curatorship)
• Inability, according to the investigator, to understand the study (non-French-speaking patient, cognitive disorders)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Robert Debré, Université de Reims

Reims, 51092, France

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Olfa MD Hamzaoui, PhD

CONTACT

0033310736973; ohamzaoui@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: comparative multicentre, open-label, investigator-led randomized controlled trial.

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 2, 2023
• Study Start: February 6, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-11

Locations

FR (1)