Mechanistic Inflammatory Sub-study Embedded Within the Albumin vs Balanced Crystalloid Trial

Sepsis Clinical Trial

— MIS-ABC Sepsis  

Official title:

Mechanistic Inflammatory Sub-study Embedded Within the Albumin vs Balanced Crystalloid Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04963569
• Other study ID #: AC21050
• Secondary ID: G/2021/130133330
• Status: Completed
• Start date: December 13, 2021
• Est. completion date: June 8, 2022

Study information

• Verified date: January 2022
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

MIS-ABC Sepsis is a sub-study looking to understand how the immune response in patients with infection changes during the early stages of the illness, as well as after intravenous fluid treatment. Participants in the main trial will be given one of two types of fluid (Human Albumin Solution (HAS) and Balanced Crystalloid) via a drip when they present to the hospital with severe infection (sepsis). The main trial is assessing which fluid is better, and we are going to take three blood samples around the time people come to hospital to see what happens to their immune system as a result of the infection and fluid treatment. We hope our findings will explain why one fluid might be better than another. It may also give us an important information about whether we can predict which people might get sicker despite treatment.

Description:

MIS-ABC Sepsis is linked to the ABC-Sepsis trial, a pilot feasibility trial recruiting patients with community acquired infection/sepsis with a NEWS2 score of five or more and randomising the participants to receiving either balanced crystalloid or 5% HAS as the intravenous resuscitation fluid up to six hours after randomisation.

MIS-ABC Sepsis will take serial blood samples from a small number of these participants, at hospital presentation and at two further points early during the patient's admission, to allow analysis of how inflammation changes during their course of illness. Investigating temporal change and differences between treatment arms of the main study will allow a nuanced analysis of the interplay between severity of illness, physiological changes over time and any potential differences between fluid treatment arm.

This is a prospective observational study enrolling patients randomised to the ABC Sepsis study. Centres for this trial will be selected from UK NHS hospitals who are recruiting to the main ABC Sepsis study. Participants will be recruited as soon as possible, and up to 12 hours after presentation to the Emergency Department, Surgical Assessment Unit or Medical Admissions Unit.

The treatment phase of the main study spans 6 hours following randomisation, with the follow up period extending to 90 days. This sub-study requires three blood samples: immediately after enrolment, at approximately 12 and 24 hours thereafter. The follow up period similarly extends to 90 days, using routine data from the medical records for follow up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 8, 2022
• Est. primary completion date: June 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to obtain informed consent

• Eligible for and randomised into the ABC Sepsis trial

Exclusion Criteria:

• Excluded from the ABC Sepsis trial

Related Conditions & MeSH terms

• Sepsis

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh	Midlothian

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	NHS Lothian, Royal College of Emergency Medicine

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longitudinal change over time in cell types and pro and anti inflammatory cytokines in sepsis.	Exploratory analysis to map mechanistic inflammatory response over time: 0, 12 and 24 hours. As the analysis is exploratory, there is no defined limit to cell types or cytokines measured.	At presentation, 12 and 24 hours.

External Links

•   ABC Sepsis Trial Registration
•   Study Webpage