Microcirculation Properties of Albumin for Fluid Resuscitation in Septic Shock

Sepsis Clinical Trial

Official title:

The Effect of Fluid Resuscitation With 20% Albumin Versus Crystalloid on the Microcirculation of Patients With Sepsis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05357339
• Other study ID #: MICALB21
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2022
• Source: St. James's Hospital, Ireland
• Contact: Rachael Cusack, FCAI, MB BCh BAO BMedSci
• Phone: 0035314103000
• Email: rcusack[@]stjames.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Sepsis
• Sepsis, Severe
• Septic Shock
• Shock
• Shock, Septic
• Toxemia

Intervention

Other:
• 20% Albumin
100ml boluses 20% Albumin
• Crystalloid
250ml bolus of crystalloid

Locations

Country	Name	City	State
Ireland	St James's Hospital	Dublin

Sponsors (2)

Lead Sponsor	Collaborator
Rachael Cusack	Grifols Biologicals, LLC

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Microcirculation parameters in response to a fluid bolus	functional capillary density, perfused capillary density after fluid bolus Proportion Perfused vessels Microvascular Flow Index Total Vessel Density	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	Duration of vasopressor administration		28 days
Secondary	Duration of Mechanical ventilation		28 days
Secondary	ICU length of stay		though to stud completion; up to 1 year
Secondary	28 day mortality		28 days