RecruitingOBSERVATIONAL

Evaluation of Parameters Collected From Routine Data for the Diagnosis of Sepsis and Septic Shock and Their Influence on Time to Diagnosis and Patient Outcome

This study is looking back at old patient records from a hospital's intensive care unit (ICU) to understand serious conditions called sepsis and septic shock. Researchers are using this information to build a clever computer program, also known as a machine learning algorithm. This program is designed to learn from the data and help doctors diagnose sepsis and septic shock more quickly and accurately in the future. The study aims to see if this new program can improve how quickly these conditions are spotted and how well patients recover. It will also look at how earlier diagnosis might affect treatment and even healthcare costs. Essentially, it's about using past information to create better tools for future patient care.

At a glance

Status

Recruiting

Sponsor

Charite University, Berlin, Germany

Enrolment target

10,000

Start

15 Jul 2022

Estimated completion

01 Dec 2027

Sepsis Septic Shock

What is this study about?

This research project is all about improving how we diagnose and treat two serious health conditions: sepsis and septic shock. Sepsis happens when your body's response to an infection goes into overdrive, causing damage to your own tissues and organs. Septic shock is an even more severe form of sepsis, where your blood pressure drops dangerously low.

To do this, scientists are looking back at a large amount of digital health information collected over many years from patients who were treated in the intensive care unit (ICU) at a hospital. They are using this historical data to develop a new, smart computer program, often called a 'machine learning algorithm'. Think of it like teaching a computer to recognise patterns that human doctors might miss, or to do it much faster.

The main goal is for this computer program to help doctors identify sepsis and septic shock earlier. Spotting these conditions quickly is really important because it means treatment can start sooner, which can make a big difference to how well a patient recovers. The study will also look at how this earlier diagnosis might affect the quality of care and even the costs involved in treating these conditions. Ultimately, the aim is to find better ways to care for patients with sepsis and septic shock.

Key takeaways

The study aims to create a computer program to help doctors diagnose sepsis earlier.
It uses past, anonymous hospital patient records.
Earlier diagnosis of sepsis can lead to better patient outcomes.
The research focuses on improving care for serious conditions like sepsis and septic shock.
No new patients are being recruited or undergoing new treatments for this study.
The study hopes to improve future healthcare by finding better ways to spot critical illnesses.

Who may be eligible?

This study is designed to look at existing information, so you won't be asked to join or take part directly. It involves reviewing medical records that have already been collected.

However, if someone were to have their records included in this study, they would have needed to be at least 18 years old. They also would have spent more than 24 hours in the intensive care unit (ICU) at the hospital from which the data is being collected.

There are no other specific reasons why someone's records would be left out of this study, as long as they meet the age and ICU stay requirements.

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.

Were you at least 18 years old?
Did you have a stay in an Intensive Care Unit (ICU)?
Was your ICU stay longer than 24 hours?
Were you treated at a hospital between January 2007 and December 2021?

Answer every question to see your result.

What does participation involve?

This study is what's called a 'retrospective' study. This means researchers are looking back at information that has already been collected, rather than asking new people to take part or try new treatments. So, you wouldn't directly 'participate' in the way you might imagine for a clinical trial involved with new medications or procedures.

Instead, researchers are examining existing anonymous medical records that were gathered as part of routine care in a hospital's intensive care unit between 2007 and 2021. There will be no visits, assessments, extra medication, or follow-up required from you. The study simply involves the careful analysis of this pre-existing digital data by the research team. The entire project, from developing the computer program to analysing all the findings, is expected to take about four years.

Potential risks and benefits

Since this study only looks back at existing, anonymised medical records, there are no direct risks to individual patients. Your personal information would be protected. The potential benefits are for future patients: if the new computer program can help spot sepsis and septic shock earlier, it could lead to quicker treatment, better recovery rates, and potentially save lives. Because you wouldn't be actively involved, there's no need to consider withdrawing from the study yourself; it involves data that has already been collected.

Locations (1)

Department of Anesthesiology and Operative Intensive Care Medicine CCM/CVK, Charité - Universitätsmedizin Berlin
Verified postcode
Berlin, Germany· Recruiting

Common questions

What is sepsis?

Sepsis is a very serious condition where your body's immune system overreacts to an infection, damaging your own tissues and organs.

What is septic shock?

Septic shock is an even more dangerous stage of sepsis where your blood pressure drops critically low.

What is a 'machine learning algorithm'?

It's a clever computer program that learns from large amounts of information to find patterns and make predictions, like helping doctors spot illnesses earlier.

Will this study use my personal medical records?

The study uses anonymous digital records from a hospital. Your personal identity would be protected and not linked to the data used.

Will I need to do anything for this study?

No, you don't need to do anything. This study looks at old, anonymous records, so there's no active participation needed from patients.

How to find out more

Claudia Spies, MD, Prof.

claudia.spies@charite.de +49 30 450 55 11 02 Official trial record

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