NCT05357339

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

1.9 years

First QC Date

January 19, 2022

Last Update Submit

October 23, 2024

Conditions

Sepsis, SevereSepsisSeptic Shock

Keywords

microcirculationsidestream dark field

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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 Arms (2)

Interventional 20% Albumin

EXPERIMENTAL

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

Control Crystalloid

ACTIVE COMPARATOR

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

Other: Crystalloid

Interventions

20% AlbuminOTHER

100ml boluses 20% Albumin

Interventional 20% Albumin
CrystalloidOTHER

100ml bolus of crystalloid

Control Crystalloid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Fluid overloaded; pulmonary oedema, significant peripheral oedema
  • Heart Failure, cardiogenic shock, recent MI
  • Receiving regular albumin 20%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St James's Hospital

Dublin, Dublin, D03 WK19, Ireland

Location

Related Publications (2)

  • Cusack R, Rodriguez A, Cantan B, Miskolci O, Connolly E, Zilahi G, Coakley JD, Martin-Loeches I. Albumin Enhances Microvascular Reactivity in Sepsis: Insights from Near-Infrared Spectroscopy and Vascular Occlusion Testing. J Clin Med. 2025 Jul 14;14(14):4982. doi: 10.3390/jcm14144982.

    PMID: 40725675DERIVED

  • Cusack RAF, Rodriguez A, Cantan B, Garduno A, Connolly E, Zilahi G, Coakley JD, Martin-Loeches I. Microcirculation properties of 20 % albumin in sepsis; a randomised controlled trial. J Crit Care. 2025 Jun;87:155039. doi: 10.1016/j.jcrc.2025.155039. Epub 2025 Feb 27.

    PMID: 40020556DERIVED

MeSH Terms

Conditions

SepsisShock, Septic

Interventions

AlbuminsCrystalloid Solutions

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and ProteinsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
ICU PhD Candidate

Study Record Dates

First Submitted

January 19, 2022

First Posted

May 2, 2022

Study Start

September 1, 2021

Primary Completion

July 10, 2023

Study Completion

December 1, 2023

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)