Clinical trial NCT05357339: Microcirculation Properties of Albumin for Fluid Resuscitation in Septic Shock
Official title: The Effect of Fluid Resuscitation with 20% Albumin Versus Crystalloid on the Microcirculation of Patients with Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis, Severe
Sepsis
Septic Shock
Keywords: microcirculation
sidestream dark field
Lead sponsor: St. James's Hospital, Ireland
Sponsor class: OTHER
Collaborators: name: Grifols Biologicals, LLC
First posted: 2022-05-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The sublingual microcirculation is impaired in sepsis and septic shock. Sidestream dark field imaging technology has been developed into a clinical tool to help the clinician assess the microcirculation at the bedside. The ideal resuscitation fluid has not been identified. The investigators aim to use this new bedside technology to establish the microcirculation properties of two popular resuscitation fluids.

Detailed description: Sepsis and septic shock are diseases of the microcirculation. Recent developments in microcirculation imaging have illustrated the extent of the impairment of the microcirculation in these diseases of critical care. Heterogenous flow, stagnation and microthrombi can all be seen clearly in the sublingual region using a sidestream dark field imaging device.

One of the key treatments for sepsis and septic shock is timely administration of intravenous fluids. Which fluid is administered is a matter for debate which has not been settled by several large trials. De-resuscitation has become increasingly important as physicians realise the implications and associated risks of excess fluid administration in ICU. Avoiding excess fluid administration at the resuscitation stage is therefore desirable. One of the prevailing theories about the function of albumin or colloid resuscitation is that it remains in the the intravascular space for a longer period of time, thereby continuing to benefit the patient and avoiding administration of excess fluid. However, recently albumin was tested against crystalloid for resuscitation and was shown to be effective but with no improvement in survival.

It is possible, however, that albumin is having an initial beneficial effect at a microcirculation level. Macrohaemodynamic improvements are not necessarily matched by improvements in blood flow and oxygen delivery to cells, this has been referred to as haemodynamic incoherence.

This randomised, prospective study aims to compare crystalloid and albumin resuscitation at a microcirculation level.

Eligibility criteria: Inclusion Criteria:

* Sepsis; suspected source of infection, tachycardia, tachypneic, hyperlactatemia, hypotensive requiring vasopressors, febrile \>38.5degrees Celsius
* Fluid responsive; pulse pressure variability \>10% or passive leg raise positive

Exclusion Criteria:

* Fluid overloaded; pulmonary oedema, significant peripheral oedema
* Heart Failure, cardiogenic shock, recent MI
* Receiving regular albumin 20%

Primary outcomes:
measure: Change in Microcirculation parameters in response to a fluid bolus
timeFrame: Baseline at recruitment before fluid given, during bolus, after bolus: immediately after, 60 minutes after and 24 hours after to determine if immediate, delayed or sustained change in microcirculation parameters is influenced by fluid bolus
Secondary outcomes:
measure: Duration of vasopressor administration
timeFrame: 28 days
measure: Duration of Mechanical ventilation
timeFrame: 28 days
measure: ICU length of stay
timeFrame: though to stud completion; up to 1 year
measure: 28 day mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: St James's Hospital
Study officials:
References: