Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Double blind randomized clinical trial comparing noradrenaline plus placebo versus noradrenaline plus terlipressin in septic shock.

This research trial is investigating treatments for a very serious condition called septic shock. In septic shock, the body's reaction to an infection causes very low blood pressure, which can damage organs. The study aims to compare the usual treatment, a medicine called noradrenaline, with a combination of noradrenaline and a new medicine called terlipressin. We want to find out if adding terlipressin can help patients recover better, reduce damage to their organs, and allow them to spend more days out of intensive care. All patients will receive noradrenaline; some will also receive terlipressin, while others will receive a placebo (a dummy medicine that looks the same) to ensure a fair comparison. This is a common way to test new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla

Enrolment target

152

Start

04 Jun 2024

Septic Shock

What is this study about?

This study is about finding better ways to treat septic shock, which is a life-threatening condition. It happens when your body has a severe reaction to an infection, causing your blood pressure to drop dangerously low. This can stop important organs like your kidneys or lungs from working properly.

Doctors currently treat septic shock with medicines like noradrenaline, which helps to raise blood pressure. This trial is looking at whether adding another medicine, called terlipressin, could make the treatment even more effective. We want to see if this combination can help protect your organs from damage and allow you to recover faster, meaning more days spent out of immediate intensive care.

The study is designed to be very fair. Some patients will receive the standard treatment (noradrenaline) plus terlipressin, while others will receive standard treatment plus a placebo. A placebo looks exactly like the real medicine but contains no active drug. This 'double-blind' approach means neither the patients nor their doctors will know who is getting which treatment, which helps to show if terlipressin truly makes a difference beyond the standard care. This is a common and important step in finding new and better medicines.

Key takeaways

The study is about finding better treatments for septic shock, a severe infection-related condition.
It compares standard care (noradrenaline) with standard care plus a new medicine (terlipressin).
The main goals are to reduce organ damage and increase recovery time out of intensive care.
Participation involves receiving one of two treatment combinations, with close medical monitoring.
This is a 'double-blind' study, meaning treatment types are unknown to patients and doctors.
You can stop participating at any time without affecting your medical treatment.

Who may be eligible?

This study is generally open to adults aged 18 and over, of any gender, who are diagnosed with septic shock.

There will be specific health criteria that doctors will check to make sure participating is safe and appropriate for each individual. For example, they might look at your overall health, other medical conditions you have, and any other medications you are taking.

It’s important to talk to your doctor or the study team to understand all the specific requirements. They will be able to tell you if this trial is a suitable option for you based on your personal health situation.

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?
Have you been diagnosed with septic shock?
Are you able to provide consent (or can a legal representative)?
Are you willing for your health to be closely monitored?
Do you have any conditions that might prevent you from joining (your doctor can advise)?
Are you receiving intensive care treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either noradrenaline plus terlipressin, or noradrenaline plus a placebo, which is a dummy medicine. You would be in an intensive care unit (ICU) for treatment and close monitoring. The study team will regularly check your health, including how well your organs are working and measurements like your blood pressure. They may also take blood and urine samples to understand how your body is responding. The total duration of your participation would depend on your recovery, but the study team would follow your progress closely during your hospital stay and potentially for a period afterwards. All medication and necessary care related to the study would be provided.

Potential risks and benefits

Taking part in a trial might offer the chance to receive a new treatment that could potentially improve your outcome, although this is not guaranteed as it's still being investigated. Your health will also be closely monitored by a dedicated team. However, there are potential risks, as with any medical treatment. Terlipressin could have side effects, and while the study aims to check for these, they can't be fully predicted. You will be told about any known or expected side effects. Remember, participating is completely voluntary, and you have the right to 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 serious condition where your body’s reaction to a severe infection causes dangerously low blood pressure, which can lead to organ damage.

What is noradrenaline?

Noradrenaline is a medicine commonly used in hospitals to help raise very low blood pressure, which is a key problem in septic shock.

What is terlipressin and why is it being tested?

Terlipressin is another medicine that could also help with blood pressure. This study wants to see if adding it to noradrenaline works better than noradrenaline alone for patients with septic shock.

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the actual medicine but doesn't contain any active drug. It helps researchers fairly compare the new medicine against standard care.

Will I know which treatment I'm getting?

No, neither you nor your doctors will know if you are getting terlipressin or the placebo. This is called 'double-blind' and ensures the study results are as unbiased as possible.