Comparing albumin and saline for treatment of patients with severe infection in the Emergency Department: A randomised trial

Phase 4

Completed

• Conditions: sepsis; Emergency medicine - Resuscitation; Infection - Other infectious diseases

• Registration Number: ACTRN12621000036819
• Lead Sponsor: Royal Brisbane and Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-18
• Study Completion: 2023-09-04
• Last Update Posted: 5 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 463

Inclusion Criteria

Adult Emergency Department patients. >=18 years of age with:
1a)Systolic blood pressure (SBP) <90mmHg within 8 hours of triage OR
1b) Lactate < 4 mmol/L

AND

2)Proven or presumed infection. Patients with presumed infection will be those where the treating senior treating emergency physician deems infection the most likely cause for the patient presentation

Exclusion Criteria

1)Jehovah’s Witness
2)Known adverse reaction to albumin administration
3)Terminal state - death seems imminent and inevitable
4)Pathological conditions in which albumin administration is clinically indicated (hepatic cirrhosis with ascites, intestinal malabsorption syndrome, nephrotic syndrome)
5)Acute congestive heart failure
6)Acute head injury
7)Inter-hospital transfer
8)Prior enrolment in the trial within the past 90 days

Patients must be enrolled as soon as possible, and within one hour of meeting inclusion criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure obtained from the patient's medical records[ 24 hours after randomization]