Microcirculation Properties of Albumin for Fluid Resuscitation in Septic Shock

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Septic Shock; Sepsis, Severe
• Intervention / Treatment: Other: 20% Albumin; Other: Crystalloid

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, D03 WK19
    • St James's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional 20% Albumin; Septic patients requiring a fluid bolus randomised to receive 100ml 20% albumin as boluses until they are stable or no longer require fluid resuscitation.	Other: 20% Albumin; 100ml boluses 20% Albumin
Active Comparator: Control Crystalloid; Septic patients requiring a fluid bolus randomised to receive 250ml boluses of crystalloid fluid until they no longer require fluid resuscitation.	Other: Crystalloid; 100ml bolus of crystalloid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Duration of vasopressor administration	28 days
Duration of Mechanical ventilation	28 days
ICU length of stay	though to stud completion; up to 1 year
28 day mortality	28 days

Collaborators and Investigators

• Sponsor: Rachael Cusack
• Collaborators: Grifols Biologicals, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: microcirculation; sidestream dark field
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Toxemia; Shock, Septic
• Other Study ID Numbers: MICALB21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No