NCT05057611: A2

Hemodynamic Phenotype and Capillary Refill Time-targeted Resuscitation Strategy

Recruiting now NA Last updated 22 July 2024

What this trial tests

NA trial testing CRT-targeted strategy associated with a clinical hemodynamic phenotyping to personalize initial resuscitation in septic shock patients in Septic Shock in 1,500 participants. Currently enrolling.

Timeline

18 March 2022

Primary endpoint
30 March 2025

30 June 2025

Quick facts

Lead sponsor	Pontificia Universidad Catolica de Chile
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,500
Start date	18 March 2022
Primary completion	30 March 2025
Estimated completion	30 June 2025
Sites	1 location across Chile

Drugs / interventions tested

• CRT-targeted strategy associated with a clinical hemodynamic phenotyping to personalize initial resuscitation in septic shock patients
• Usual care (UC)

Conditions studied

• Septic Shock — all drugs for Septic Shock →

Sponsor

Pontificia Universidad Catolica de Chile — full company profile →

Who can join

18 and older, any sex, with Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Septic shock is associated with a high mortality risk. Fluid overload occurs when fluids are administered to fluid unresponsive patients, but also when inappropriate resuscitation goals are pursued. Alongside, evidence confirms that abnormal peripheral perfusion after resuscitation is associated with increased morbidity and mortality. Targeted resuscitation associates with lower mortality, less organ dysfunction, and less intensity of treatment. Over-resuscitation may contribute to a worse outcome.

Many patients remain hypovolemic after initial resuscitation. Others present very low diastolic arterial pressures (DAP) reflecting profound vasoplegia and may benefit from early norepinephrine (NE) instead of fluids. Administering fluids in this setting could increase the risk of fluid overload. In addition, relevant myocardial dysfunction is present in a significant number of patients. Pulse pressure (PP) and DAP evaluation may help clinicians to individualize initial management sparing unnecessary fluid loading.

Objective: To test if a CRT-targeted resuscitation based on clinical hemodynamic phenotyping can improve a hierarchical clinical outcome - mortality, time to cessation of vital support, and length of hospital stay, all within 28 days - in septic shock patients as compared to usual care.

A2 is a multicenter randomized controlled trial (RCT) comparing a CRT-targeted, hemodynamics-based resuscitation strategy with usual care in patients with early septic shock during a 6 h intervention period. A sample size of 1500 patients was calculated to detect a 6% absolute reduction in mortality in the CRT group, and the win-ratio method will be used to test the superiority in the hierarchical outcomes mentioned above.

The combination of a CRT-targeted strategy with a clinical hemodynamic phenotyping may aid to personalize initial resuscitation with potential additional fluid-sparing effects. To categorize patients at baseline according to PP may conduct patients with low PP (\<40mmHg) to fluid responsiveness (FR) assessment and eventually fluid boluses, while patients with normal PP will be treated according to DAP, adjusting NE when to avoid further fluids loading in patients who normalize CRT.

Fluid resuscitation will be focused on FR+ hypoperfused patients to prevent harmful fluid administration in FR- patients.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial study protocol.
   Kattan E, Bakker J, Estenssoro E, Ospina-Tascón GA, et al · · 2022 · cited 32× · PMID 35766659 · DOI 10.5935/0103-507x.20220004-pt
2. Personalized Hemodynamic Resuscitation Targeting Capillary Refill Time in Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial.
   ANDROMEDA-SHOCK-2 Investigators for the ANDROMEDA Research Network, Spanish Society of Anesthesiology, Reanimation and Pain Therapy (SEDAR), and Latin American Intensive Care Network (LIVEN), et al · · 2025 · cited 31× · PMID 41159835 · DOI 10.1001/jama.2025.20402
3. Agreement between Capillary Refill Time measured at Finger and Earlobe sites in different positions: a pilot prospective study on healthy volunteers.
   La Via L, Sanfilippo F, Continella C, Triolo T, et al · · 2023 · cited 24× · PMID 36653739 · DOI 10.1186/s12871-022-01920-1
4. Doppler identified venous congestion in septic shock: protocol for an international, multi-centre prospective cohort study (Andromeda-VEXUS).
   Prager R, Argaiz E, Pratte M, Rola P, et al · · 2023 · cited 17× · PMID 37487682 · DOI 10.1136/bmjopen-2023-074843
5. Statistical analysis plan for hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: the ANDROMEDA-SHOCK-2 randomized clinical trial.
   Orozco N, García-Gallardo G, Cavalcanti AB, Santos TMD, et al · · 2025 · cited 2× · PMID 39879432 · DOI 10.62675/2965-2774.20250140
6. ESICM LIVES 2025
   · 2025