All studies
RecruitingNAINTERVENTIONAL

Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients

This study is investigating a different approach to managing adults who have septic shock, a very serious condition caused by an infection. Doctors usually give fluids to these patients. This trial wants to see if giving less of a certain type of fluid, specifically fluids not meant for immediate emergency resuscitation, could be more helpful or harmful compared to the standard amount. The researchers hope to understand if a more controlled approach to these fluids can improve patient outcomes for those in intensive care with septic shock. This is important to ensure patients receive the best possible care for this life-threatening illness.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Region Skane
Enrolment target
1,850
Start
27 Nov 2023
Estimated completion
01 Jul 2028

What is this study about?

Imagine your body is fighting a very serious infection. When this infection becomes overwhelming, it can lead to a dangerous condition called septic shock. In septic shock, your blood pressure can drop very low, and your organs might not get enough blood. To help with this, doctors often give fluids through a drip.

This study is looking at whether giving a reduced amount of certain fluids, specifically 'non-resuscitation' fluids (fluids not used for immediate life-saving emergency treatment), might be a better approach for adults with septic shock. Currently, there's a standard way doctors give fluids, and this study wants to compare that 'usual care' with a new approach where the amount of these non-emergency fluids is carefully limited.

The main goal is to figure out if being more careful with these fluids could lead to better outcomes for patients, or if it might have any downsides. By understanding this, doctors can improve how they care for people with septic shock, helping them on their road to recovery.

Key takeaways

  • This study evaluates different ways of giving fluids to people with septic shock.
  • It compares usual fluid care with a plan to give less non-emergency fluids.
  • The goal is to find out if limiting fluids improves recovery for adult patients.
  • Participation involves close monitoring in the intensive care unit.
  • You can discuss this with your doctor if you or a loved one meet the criteria.

Who may be eligible?

This study is looking for adults aged 18 or older. To be considered, you would need to have been diagnosed with septic shock within 12 hours of being admitted to an intensive care unit (ICU).

Having septic shock means you have a suspected or confirmed infection, a specific level of lactate (a chemical in your blood), and need medication to keep your blood pressure stable, even after already receiving a good amount of fluids, such as more than a litre in the last 12 hours.

However, you wouldn't be able to join the study if you are pregnant or think you might be, if you have already been part of this specific trial before, or if more than 12 hours have passed since you were admitted to the ICU by the time your suitability is checked.

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. Are you 18 years old or older?
  2. Have you been diagnosed with septic shock within the last 12 hours of ICU admission?
  3. Are you currently receiving medication to help your blood pressure stay up?
  4. Are you not pregnant or think you might be?
  5. Have you not been part of this specific study before?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve your medical team following a specific plan for managing the fluids you receive, apart from those given in an emergency. This plan would either be the usual care or a reduced amount of non-emergency fluids. You would continue to receive the standard medical care for septic shock, and your health would be closely monitored by your medical team in the intensive care unit. The total duration of your participation would depend on your hospital stay and recovery from septic shock.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving a new approach to fluid management that could improve your recovery from septic shock, although this is what the study aims to discover. As with any medical intervention, there could be risks, though these would be carefully monitored by your medical team. You are always free to withdraw from the study at any time without affecting the quality of your medical care.

Locations (22)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Helsinki University Hospital
    Verified postcode
    Helsinki, Finland· Recruiting
  • Kuopio University Hospital
    Verified postcode
    Kuopio, Finland· Not yet recruiting
  • Tampere University Hospital
    Verified postcode
    Tampere, Finland· Not yet recruiting
  • Turku University Hospital
    Verified postcode
    Turku, Finland· Not yet recruiting
  • Danderyd Hospital
    Verified postcode
    Danderyd, Sweden· Recruiting
  • Malar Hospital
    Verified postcode
    Eskilstuna, Sweden· Recruiting
  • Falun Hospital
    Verified postcode
    Falun, Sweden· Recruiting
  • Sahlgrenska University Hospital
    Verified postcode
    Gothenburg, Sweden· Recruiting
  • Östra Hospital
    Verified postcode
    Gothenburg, Sweden· Recruiting
  • Halmstad Hospital
    Verified postcode
    Halmstad, Sweden· Recruiting
  • Helsingborg Hospital
    Verified postcode
    Helsingborg, Sweden· Recruiting
  • Skåne University Hospital, Lund
    Verified postcode
    Lund, Sweden· Recruiting

Common questions

What is septic shock?

Septic shock is a very serious condition caused by your body reacting to an infection. It can cause very low blood pressure and affect how your organs work.

What are 'non-resuscitation' fluids?

These are fluids given through a drip that are not for immediate emergency life support, but still important for your overall treatment and body function.

Will I still get emergency fluids if I need them?

Yes, absolutely. This study only looks at how certain non-emergency fluids are given. You will always receive any emergency life-saving treatment, including fluids, if your doctors decide you need them.

How long will I be in the study?

Your participation will be for the duration of your illness and hospital stay related to septic shock.

Who is running this study?

This study is being conducted by medical researchers and doctors who are experts in treating septic shock.

How to find out more

Peter Bentzer

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 "Protocolized Reduction of Non-resuscitation Fluids Versus Us…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.