None listed
Conditions
Brief summary
Global estimates suggest that approximately 5 million people die from infection each year. 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). Any of these fluids can be used by Emergency physicians, but crystalloids are most commonly used in standard care. There is some initial evidence that albumin may result in better outcomes for patients with severe infections, but further quality trials are required to validate these initial studies. Within this study, we will randomise patients with severe infection to receive either albumin or crystalloids while they are in the Emergency Department. The aim is to determine whether albumin improves the patient’s blood pressure, reduces the amount of fluid they need to receive, reduces organ failure, and reduces the need for intensive care admission.. 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. The primary hypothesis is that In patients presenting to the Emergency Department with presumed infection, usual care plus intervention with 400mL 20% albumin IV over 4 hours compared to usual treatment without albumin results in higher systolic blood pressure at 24 hours.
Interventions
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. Adherence to the intervention will be monitored using the patient medication chart.
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 guidel
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. Adherence to the intervention will be monitored using the patient medication chart. 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 or invasive monitoring, as available. Both crystalloid and albumin will be administered while the patient is in the Emergency Department. This time period is on average 4-6 hours. Crystalloid and albumin may also be provided throughout the hospital stay as required for standard care at the discretion of inpatient treating teams.
Sponsors
Royal Brisbane and Women's Hospital
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 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.
Outcome results
None listed