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Clinical Trials/NCT05357339
NCT05357339
Completed
Not Applicable

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

Rachael Cusack1 site in 1 country100 target enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sepsis, Severe
Sponsor
Rachael Cusack
Enrollment
100
Locations
1
Primary Endpoint
Change in Microcirculation parameters in response to a fluid bolus
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
December 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Rachael Cusack
Responsible Party
Sponsor Investigator
Principal Investigator

Rachael Cusack

ICU PhD Candidate

St. James's Hospital, Ireland

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%

Outcomes

Primary Outcomes

Change in Microcirculation parameters in response to a fluid bolus

Time Frame: 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

functional capillary density, perfused capillary density after fluid bolus Proportion Perfused vessels Microvascular Flow Index Total Vessel Density

Secondary Outcomes

  • 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)

Study Sites (1)

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