Crystalloid versus Albumin in the Resuscitation of Emergency Department Patients with Septic Shock

Crystalloid versus Albumin for improving organ dysfunction and microcirculation in Emergency Department Patients with Septic Shock

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000453987

Acronym

CARESS

Enrollment

100

Registered

2011-05-03

Start date

2011-06-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

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 saline and 4% albumin. Further work is required to determine which of these fluids is most effective in improving the outcome of patients with severe infection. This project aims to determine whether 4% albumin solution is superior to crystalloid solutions for fluid resuscitation of patients presenting to the Emergency Department (ED) with septic shock. A randomised controlled trial is proposed, in which 100 patients will be enrolled over 2 years, each assigned to receive either 4% albumin or crystalloid fluids for the first six hours of resuscitation in the ED. All other aspects of care will be common to both groups and according to evidence-based guidelines. A variety of outcomes will be measured, including organ dysfunction scores, inflammatory markers and measures of circulation.

Interventions

Albumin for fluid resuscitation. Albumin will be given via intravenous injection. Dose will be determined by treating clinician in accordance with current best practice. Albumin will be given during the resuscitation phase while in the Emergency Department

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

Inclusion criteria

1. Infection (according to treating emergency physician’s clinical assessment) 2. Shock, as defined by either: a. Hypotension (Systolic blood pressure <90 or Mean arterial pressure <65 despite 20ml/kg fluid bolus), or b. Elevated lactate (arterial or venous, >4.0 mmol/l) 3. At least 2 systemic inflammatory response syndrome (SIRS) criteria present, defined as a. Core temperature < 36.0 degrees C or > 38 degrees C b. Heart rate > 90 beats/minute c. Respiratory rate > 20 breaths/minute or PaC02 < 32 mmHg d. White cell count > 12 or < 4 * 109/L 4. Antimicrobials commenced

Exclusion criteria

1. Inter-hospital transfer 2. >8 hours in ED 3. Death is expected and imminent. 4. Underlying disease process with a life expectancy of <90 days. 5. Jehovah’s Witness 6. Age<18 7. A “limitation of therapy” order has been documented restricting implementation of the study protocol or treating team clinician deems aggressive care unsuitable.

Outcome results