Ongoing, recruitingTherapeutic use (Phase IV)Interventional

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

This research, called ANDROMEDA-SHOCK-2, is a study for people who are very unwell with severe blood poisoning, known as septic shock. The main aim is to find the most effective way to give fluids directly into the bloodstream (intravenous fluids) to help patients recover. Doctors in this study are comparing two common fluid types, 'Suero Fisiológico Vitulia 0,9%' and 'Lactato Ringer Braun', to see which helps improve blood flow and overall health more effectively. They'll be checking important things like how many people survive within 28 days, how quickly patients no longer need help with their vital body functions, and how long they stay in hospital. This study is already running and is helping us understand how to improve care for this serious condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Pontificia Universidad Catolica de Chile

Enrolment target

500

Start

23 Jan 2025

Septic Shock

What is this study about?

Imagine your body as a complex machine. Sometimes, a severe infection can make this machine go into overdrive, leading to a life-threatening condition called septic shock. In septic shock, your blood pressure can drop dangerously low, and your organs don't get enough blood flow.

This study, called ANDROMEDA-SHOCK-2, is looking at the best way to help people who are in septic shock. Specifically, it's comparing two types of fluids that can be given directly into your veins (through a drip). The aim is to see if one type of fluid is better at improving your circulation and helping you recover. Doctors will be very carefully monitoring how your body responds, paying close attention to things like how quickly blood returns to your fingertips when pressed – a simple but important sign of good blood flow.

By comparing these different fluid treatments, the researchers hope to find out which one gives patients the best chance of survival, helps them get off life support faster, and reduces how long they need to stay in hospital. This information will help doctors all over the world provide even better care for people with septic shock in the future.

Key takeaways

The study helps doctors find better ways to treat severe blood poisoning (septic shock).
It compares two standard types of fluids given through a drip.
The goal is to improve patient survival, reduce time on life support, and shorten hospital stays.
You would receive close monitoring and care if you participate.
Only adults aged 18 and over with septic shock can take part.

Who may be eligible?

This study is for adults aged 18 and over who have been diagnosed with septic shock. Both men and women can take part.

Being chosen for this study means your doctors think you could benefit from being part of this research, which aims to improve treatments.

Because septic shock is a very serious condition, the decision to include someone in the study is made very carefully by the medical team looking after them.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you currently have a diagnosis of septic shock?
Are you able to receive fluids intravenously (through a drip)?
Have your doctors determined you are a suitable candidate for this specific research study?

Answer every question to see your result.

What does participation involve?

If you or someone you know is eligible and agrees to take part, the study involves receiving one of two standard intravenous fluid treatments. You will receive very close monitoring from the medical team, which is typical for someone with septic shock. Doctors will regularly check your vital signs and how well your body's circulation is working, for example, by checking your capillary refill time (how quickly colour returns to your skin after gentle pressure).

The study mainly involves observing your progress and recovery while you are in the hospital. Doctors will follow up on your health for 28 days after you start treatment, looking at things like your recovery and how long you stay in hospital.

Potential risks and benefits

Taking part in a study like this means you would receive very close medical attention, which can be reassuring. The treatments being compared are both standard fluids used in hospitals for septic shock, so you would be receiving care that doctors already use. There's a chance one fluid might be slightly more effective for you than the other, which is what the study aims to find out. As with any medical treatment for a serious condition, there are always potential risks; however, the study doesn't introduce completely new, unproven drugs, but rather compares known treatments. You are always free to ask questions and can withdraw from the study at any time without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is septic shock?

Septic shock is a very severe and life-threatening condition where a serious infection leads to dangerously low blood pressure and organs not getting enough blood.

What kind of treatments are being tested?

Doctors are comparing two common types of fluids given into your veins (intravenous fluids) — 'Suero Fisiológico Vitulia 0,9%' and 'Lactato Ringer Braun' — to see which works best for improving blood flow.

What does 'capillary refill time-targeted resuscitation' mean?

It means doctors will check how quickly the colour returns to your skin, for example, on your fingertip, after it's gently pressed. This helps them understand how well blood is flowing in your body and guide your fluid treatment.

How long will I be in the study?

The study will follow your progress mainly while you are in the hospital, and then monitor certain outcomes for up to 28 days after you start treatment.

Will I know which fluid I'm getting?

In some studies, neither the patient nor the doctors know which treatment is given (this is called 'blinding') to ensure fair results. Your medical team will explain the specific details of this study if you are eligible.