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Intervention with concentrated albumin for resuscitation of undifferentiated sepsis - Multi Day

Intervention with concentrated albumin for resuscitation of undifferentiated sepsis in Emergency Department Patients - Multi Day: A randomised controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000327583
Acronym
ICARUS-MD
Enrollment
10
Registered
2024-03-25
Start date
2024-01-01
Completion date
2025-12-31
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Research into improved management and treatment for patients with infection is essential for reducing such mortality. Individuals who present to the Emergency Department with severe infections are treated with fluids in the vein to maintain optimal blood volume, keep the heart working properly, and keep tissues well oxygenated. There are a number of fluids that Emergency Physicians can provide to patients, including crystalloids (water-based fluids that include salts and other water-soluble molecules), and albumin (a fluid manufactured from human plasma). Within this study, we will randomise patients with severe infection to receive either albumin or crystalloids. The aim is to determine whether albumin improves the patient’s outcome.. The results of the study will provide emergency doctors with important information about how to best treat patients with infections and potentially reduce the number of deaths.

Interventions

Immediately after randomisation, the intervention group will receive 20% human serum albumin, infused intravenously at 100mL/hr over 4 hours, concurrently with standard crystalloid-based fluid therapy as deemed appropriate by the treating emergency team. Over the next 10 days (or until discharge if the patient is discharged prior to 10 days), patients will receive a daily dose of 20% albumin, with the dose determined by the serum albumin concentration in the preceding 24 hours. Specifically, pa

Immediately after randomisation, the intervention group will receive 20% human serum albumin, infused intravenously at 100mL/hr over 4 hours, concurrently with standard crystalloid-based fluid therapy as deemed appropriate by the treating emergency team. Over the next 10 days (or until discharge if the patient is discharged prior to 10 days), patients will receive a daily dose of 20% albumin, with the dose determined by the serum albumin concentration in the preceding 24 hours. Specifically, patients will receive: 300mL if serum albumin is <25g/L, 200mL if serum albumin is >=25 and <30g/L 100mL if serum albumin unmeasured within 48hrs, or previous measurement <35g/L No dose if previous serum albumin >=35g/L Adherence to the intervention will be monitored using the patient medication chart. Initial doses of crystalloid and albumin will be administered while the patient is in the Emergency Department. This time period is on average 4-6 hours. The remaining doses will be administered while the patient is in a ward within the hospital. Crystalloid fluid therapies will be administered to patients in both study arms according to evidence-based guidelines such as those disseminated by the Surviving Sepsis Campaign. Modern guidelines advocate discrete bolus fluid therapy (most clinicians utilise volumes of 500mL) with frequent reassessment, clinical examination and evaluation of available physiologic variables (heart rate, blood pressure, arterial oxygen saturation, respiratory rate, temperature, urine output, and others, as available) as well as other non-invasive (e.g., capnography) or invasive monitoring (e.g., arterial blood pressure), as available.

Sponsors

Royal Brisbane and Women's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult ED patients (greater than or equal to 18 years) with: 1) Systolic blood pressure (SBP) <90mmHg within 8 hours of triage (or lactate greater than or equal to 4) 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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026