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Completed

NCT Number: NCT05357339

Microcirculation Properties of Albumin for Fluid Resuscitation in Septic Shock

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St James's Hospital

Dublin, D03 WK19, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

20% Albumin

Other

100ml boluses 20% Albumin

crystalloid

Other

100ml bolus of crystalloid

Primary outcomes

  1. 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

  1. Duration of vasopressor administration

    Time frame: 28 days

  2. Duration of Mechanical ventilation

    Time frame: 28 days

  3. ICU length of stay

    Time frame: though to stud completion; up to 1 year

  4. 28 day mortality

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Rachael Cusack

Other

Collaborators

  • Grifols Biologicals, LLC

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 2, 2022
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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