CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 300 enrolled
Drug / intervention
Human albumin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04540094
NCT04540094Phase 3Completed
CompareCT.gov

Feasibility of 5% Albumin Compared With Balanced Crystalloid, as Intravenous Fluid Resuscitation in Adult Patients With Sepsis, Presenting as an Emergency to Hospital: ABC Sepsis Trial

University of Edinburgh·interventional·Posted Sep 7, 2020·Updated Oct 4, 2024

In Brief

A Phase 3 clinical trial evaluating Human albumin and Balanced crystalloid solution for Sepsis. Completed, enrolled 300 participants across 15 sites.

Detailed Summary

The aim of this research study is to compare two different fluids (Human Albumin Solution (HAS) and Balanced Crystalloid that are given via a drip to patients with severe infection (sepsis). The investigators plan to see which fluid is better, and to see if they have a role in improving a patient's recovery time, reducing complications and the length of time they stay in hospital. This study plans to find out if there is evidence that one fluid is better overall to determine the need for a subsequent definitive trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedSep 7, 2020
Enrollment StartJun 1, 2021
Primary CompletionSep 12, 2022
Study CompletionApr 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.8 years ago

Interventions

Human albumindrug

Any preparation of 5% Human Albumin Solution which has marketing authorisation in the UK to be used for this indication and is stocked by local hospital pharmacies at the participating sites, may be prescribed in this study

Balanced crystalloid solutiondrug

Any preparation of intravenous "balanced" crystalloid which has marketing authorisation in the UK to be used for this indication and is stocked by local hospital pharmacies at the participating sites, may be prescribed in this study.