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

NCT ID: NCT04963569

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-13
• Study Completion Date: 2022-06-08

Brief 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.

Detailed 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.

Conditions

Sepsis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Albumin

Participants enrolled in the ABC Sepsis trial who have been randomised to 5% Human Albumin Solution as the sole resuscitative fluid in the first 6 hours.

No interventions assigned to this group

Balanced Crystalloid

Participants enrolled in the ABC Sepsis trial who have been randomised to Balanced Crystalloid as the sole resuscitative fluid in the first 6 hours.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Able to obtain informed consent
• Eligible for and randomised into the ABC Sepsis trial

Exclusion Criteria

• Excluded from the ABC Sepsis trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Lothian

OTHER_GOV

Sponsor Role: collaborator

Royal College of Emergency Medicine

OTHER

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alasdair Gray, MD

Role: STUDY_DIRECTOR

University of Edinburgh

Locations

Royal Infirmary of Edinburgh

Edinburgh, Midlothian, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Related Links

https://www.clinicaltrials.gov/ct2/show/NCT04540094

ABC Sepsis Trial Registration

https://www.emergeresearch.org/trial/mis-abc-sepsis/

Study Webpage

Other Identifiers

G/2021/1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

301333

Identifier Type: OTHER

Identifier Source: secondary_id

300332

Identifier Type: OTHER

Identifier Source: secondary_id

AC21050

Identifier Type: -

Identifier Source: org_study_id