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Microcirculation Properties of Albumin for Fluid Resuscitation in Septic Shock

Primary Purpose

Sepsis, Severe, Sepsis, Septic Shock

Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
20% Albumin
Crystalloid
Sponsored by
Rachael Cusack
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis, Severe focused on measuring microcirculation, sidestream dark field

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • St James's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional 20% Albumin

Control Crystalloid

Arm Description

Septic patients requiring a fluid bolus randomised to receive 100ml 20% albumin as boluses until they are stable or no longer require fluid resuscitation.

Septic patients requiring a fluid bolus randomised to receive 250ml boluses of crystalloid fluid until they no longer require fluid resuscitation.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of vasopressor administration
Duration of Mechanical ventilation
ICU length of stay
28 day mortality

Full Information

First Posted
January 19, 2022
Last Updated
April 26, 2022
Sponsor
Rachael Cusack
Collaborators
Grifols Biologicals, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05357339
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rachael Cusack
Collaborators
Grifols Biologicals, LLC

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Severe, Sepsis, Septic Shock
Keywords
microcirculation, sidestream dark field

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional 20% Albumin
Arm Type
Experimental
Arm Description
Septic patients requiring a fluid bolus randomised to receive 100ml 20% albumin as boluses until they are stable or no longer require fluid resuscitation.
Arm Title
Control Crystalloid
Arm Type
Active Comparator
Arm Description
Septic patients requiring a fluid bolus randomised to receive 250ml boluses of crystalloid fluid until they no longer require fluid resuscitation.
Intervention Type
Other
Intervention Name(s)
20% Albumin
Intervention Description
100ml boluses 20% Albumin
Intervention Type
Other
Intervention Name(s)
Crystalloid
Intervention Description
250ml bolus of crystalloid
Primary Outcome Measure Information:
Title
Change in Microcirculation parameters in response to a fluid bolus
Description
functional capillary density, perfused capillary density after fluid bolus Proportion Perfused vessels Microvascular Flow Index Total Vessel Density
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
Secondary Outcome Measure Information:
Title
Duration of vasopressor administration
Time Frame
28 days
Title
Duration of Mechanical ventilation
Time Frame
28 days
Title
ICU length of stay
Time Frame
though to stud completion; up to 1 year
Title
28 day mortality
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachael Cusack, FCAI, MB BCh BAO BMedSci
Phone
0035314103000
Email
rcusack@stjames.ie
Facility Information:
Facility Name
St James's Hospital
City
Dublin
ZIP/Postal Code
D03 WK19
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachael Cusack
Phone
0872280676
Email
rcusack@stjames.ie
First Name & Middle Initial & Last Name & Degree
Ignacio Martin-Loeches

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Microcirculation Properties of Albumin for Fluid Resuscitation in Septic Shock

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