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Study on Resuscitation in Early Septic Shock Using Sodium Chloride and a Drug Combination for Patients with Septic Shock

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What is this study about?

This clinical trial is focused on studying a condition known as septic shock. Septic shock is a serious medical condition that occurs when an infection leads to dangerously low blood pressure and other complications. The study aims to explore a new approach to treating septic shock by using a method called capillary refill time-targeted resuscitation. This method involves monitoring how quickly blood returns to the small blood vessels in the skin after pressure is applied, which can help guide treatment decisions.

Two different solutions for infusion will be used in this study. One is called Suero Fisiológico Vitulia 0.9% solution for infusion, which contains sodium chloride, a common salt used to help maintain fluid balance in the body. The other is Lactato Ringer Braun solution for infusion, which contains a mix of potassium chloride, sodium chloride, calcium chloride dihydrate, and sodium lactate. These substances are used to help restore the balance of electrolytes, which are minerals in the body that carry an electric charge and are essential for many bodily functions.

The purpose of the study is to determine if this new treatment approach can improve outcomes for patients with septic shock, such as reducing the risk of death, shortening the time patients need vital support, and decreasing the length of hospital stay, all within 28 days. Participants in the study will receive either the new treatment approach or the usual care, and their progress will be monitored over this period. The study will help to understand if this new method can provide better results compared to the standard treatment currently used for septic shock.

1 joining the study

Upon joining the study, the patient is confirmed to meet the inclusion criteria, which includes being an adult with septic shock as defined by the Sepsis-3 consensus. This involves having a suspected or confirmed infection, high levels of lactate in the blood, and a need for norepinephrine due to low blood pressure after receiving at least 1000 mL of fluids in one hour.

2 initial treatment phase

The patient receives treatment with sodium chloride or a combination of potassium chloride, sodium chloride, calcium chloride dihydrate, and sodium lactate. These are administered as a solution for infusion through an intravenous line. The specific solution used is either ‘Suero Fisiológico Vitulia 0.9%’ or ‘Lactato Ringer Braun’.

3 monitoring and adjustment

The patient’s response to the treatment is closely monitored. The goal is to target the capillary refill time (CRT), which is a measure of how quickly blood returns to the capillaries after pressure is applied. Adjustments to the treatment may be made based on the patient’s hemodynamic profile, which involves assessing the blood flow and circulation.

4 evaluation of outcomes

The primary outcome of the study is a composite measure that includes all-cause mortality within 28 days, the time it takes for vital support to be no longer needed, and the length of the hospital stay, all measured within a 28-day period. Secondary outcomes focus on all-cause mortality within the same timeframe.

5 completion of the study

The study is expected to conclude by December 19, 2025. The patient’s participation will be evaluated based on the outcomes measured during the study period.

Who Can Join the Study?

  • Participants must be adults, which means they need to be 18 years or older.
  • Participants must have septic shock. This is a serious condition that happens when an infection leads to very low blood pressure, even after receiving fluids.
  • Both men and women can participate in the study.
  • Participants should not be part of a vulnerable population, meaning they should not be in a group that needs special protection or care.

Who Cannot Join the Study?

  • Patients who are not experiencing septic shock. Septic shock is a serious condition that happens when an infection leads to dangerously low blood pressure.
  • Patients who are younger than 18 years old or older than 65 years old.
  • Patients who belong to vulnerable populations, which means groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Hospital Universitario Rio Hortega Valladolid Spain
Hospital Universitario San Juan De Alicante Sant Joan D'alacant Spain
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario De Cruces Barakaldo Spain
Hospital Universitario De Leon Leon Spain
Hospital General Universitario De Valencia Valencia Spain
Hospital General Universitario De Ciudad Real Ciudad Real Spain
Hospital Alvaro Cunqueiro Vigo Spain
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Hothhiiy Pjnizt Seni Vigo Spain
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
19.12.2024

Trial locations

Investigated drugs:

CRT-Targeted Resuscitation: This therapy involves adjusting the treatment of septic shock patients based on their capillary refill time (CRT). The goal is to improve outcomes such as survival rates, reduce the time patients need vital support, and shorten hospital stays. This approach uses clinical hemodynamic phenotyping to tailor the resuscitation process to each patient’s specific needs.

Investigated diseases:

Septic Shock – Septic shock is a severe and widespread infection that leads to dangerously low blood pressure and abnormalities in cellular metabolism. It occurs when an infection in the body triggers an extreme immune response, causing inflammation and blood clotting throughout the body. This can result in reduced blood flow to vital organs, leading to organ dysfunction. The condition progresses rapidly and requires immediate medical attention to prevent further complications. It is often associated with symptoms such as fever, chills, confusion, and difficulty breathing. The progression of septic shock can lead to multiple organ failure if not managed promptly.

Trial ID:
2024-519691-10-00
Protocol code:
ANDROMEDA-SHOCK-2
NCT ID:
NCT05057611
Trial Phase:
Therapeutic confirmatory (Phase III)

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