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RecruitingPhase IVInterventional

SepTiC: Sepsis Trials in Critical Care

Sepsis is a life-threatening response to infection that needs urgent medical care. The SepTiC study is taking place in up to 60 intensive care units (ICUs) across the UK. It aims to find out if fine-tuning standard treatments can help patients recover faster and live longer. Patients taking part may be placed into different treatment groups. These test guided antibiotic therapy, careful management of intravenous drips (fluids), and an immune-boosting medicine called GM-CSF for those who are most severely ill. Because sepsis is an emergency and patients are often unconscious, doctors start treatments immediately and speak with family members as soon as possible. Patients are followed up during their hospital stay and asked to complete a survey about their recovery after six months.

At a glance

Status
Recruiting
Phase
Phase IV
Sponsor
Imperial College London
Enrolment target
3,758
Start
02 Jan 2023
Estimated completion
30 Apr 2027

What is this study about?

Sepsis occurs when the body's immune system overreacts to an infection, injuring its own tissues and organs. It is a medical emergency that often requires treatment in an intensive care unit (ICU). Doctors usually treat sepsis with antibiotics and intravenous fluids, but finding the exact right balance for each person remains a major challenge in critical care.

The SepTiC trial is studying three different ways to improve care. First, it looks at whether closely tailoring antibiotics improves recovery compared to standard practice. Second, it tests whether giving slightly less fluid through a drip is safer than usual fluid amounts. Third, for the most severely ill patients, it tests whether an immune-stimulating drug called GM-CSF can help the body clear infection better than a dummy treatment (placebo).

By comparing these approaches side by side in NHS hospitals, researchers hope to build clear evidence for the best ways to manage sepsis. The findings could shape critical care guidelines across the UK and help future patients survive this severe condition with fewer long-term health problems.

Key takeaways

  • SepTiC is a UK-wide intensive care trial testing better treatments for sepsis.
  • It examines tailored antibiotics, careful drip fluids, and an immune drug called GM-CSF.
  • Because sepsis is an emergency, study treatments begin quickly, with family consulted as soon as possible.
  • Follow-up involves normal hospital monitoring and a simple six-month questionnaire at home.
  • Participation is voluntary, and taking part does not interfere with standard, round-the-clock NHS care.

Who may be eligible?

This study is for adults aged 16 and older who have been admitted to an intensive care unit with suspected sepsis. Participants need to be receiving antibiotics through a vein and must be expected to stay in the ICU for at least two more days. Because early treatment is so crucial, patients are usually enrolled within their first 24 hours in intensive care.

People cannot take part if they have already been in the ICU for sepsis during their current hospital stay, weigh less than 40 kilograms (around 6 stone 4 pounds), or are not expected to survive the next 24 hours. Certain complex infections, such as tuberculosis or heart valve infections, also mean a patient cannot join.

Only a smaller group of the sickest patients—such as those on a breathing machine or needing support for multiple failing organs—will be considered for the third part of the study testing the immune-boosting drug GM-CSF.

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.

  1. Aged 16 or older
  2. Currently admitted to an intensive care unit (ICU) in the UK
  3. Treated for suspected sepsis with intravenous antibiotics
  4. Expected to stay in intensive care for at least two calendar days
  5. Admitted to the ICU within the past 24 hours
  6. Weigh at least 40 kg (6 stone 4 lbs)
Answer every question to see your result.

What does participation involve?

Taking part happens while the patient is already being treated in the intensive care unit. Because sepsis is an emergency and patients are often too unwell to speak for themselves, doctors start the study treatments straight away. A research team member will speak with family members as soon as possible to explain the trial. Once the patient is awake and recovered, they will be given full information and asked if they wish to stay in the study.

Depending on which part of the trial a person enters, doctors will adjust their antibiotics, manage their fluid drip, or give injections of either the study drug (GM-CSF) or a dummy medicine (placebo). Care teams will take a small blood sample (about two tablespoons) for future research, but all other monitoring is part of regular ICU care.

Doctors track each patient's progress until they leave the hospital. Six months after joining, the study team will contact the patient to complete a questionnaire about their quality of life, memory, and everyday thinking. The team will also check general health records at 90 days and one year to see how recovery is going.

Potential risks and benefits

Participants might not benefit directly from taking part, but the results could help doctors treat future sepsis patients more successfully. The main risks involve potential side effects from the study drug, GM-CSF, which can include temporary redness or mild pain where the injection is given, or very rarely, an allergic reaction. Patients are monitored around the clock by ICU staff, and treatments are stopped immediately if safety issues arise. Joining is voluntary, and a patient or their family can withdraw from the study at any time without their standard NHS care being affected.

Locations (1)

  • -
    Approximate
    -, England

Common questions

Why was my relative entered into the trial before we were asked?

Sepsis treatments work best when started immediately. Because patients are often unconscious or confused, the law allows doctors to start study treatments right away, contacting family as soon as practically possible.

What is GM-CSF?

GM-CSF is a medicine that helps the body produce more white blood cells. In this trial, researchers want to see if it helps severely ill patients fight off infection.

Does this trial replace standard NHS intensive care?

No. Patients still receive full, high-level intensive care. The study simply compares slightly different ways of managing fluids, antibiotics, and immune support alongside standard care.

Can I leave the study once I feel better?

Yes. Once you regain capacity, the team will explain the trial. You can decide to continue or leave, and leaving will never affect your medical care.

Will taking part mean extra hospital visits?

No. All treatments happen during your planned hospital stay. The only follow-up after going home is a questionnaire sent to you after six months.

How to find out more

Janis Best-Lane

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "SepTiC: Sepsis Trials in Critical Care…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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