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NCT Number: NCT05606536

The Impact of Intra-operative Fluid Infusion Rate on Microcirculation

Intraoperative fluid therapy (IFT) is an integral part of anesthesia care during surgery. Its main indication is the optimization of oxygen supply to the tissues. For elective surgery that is not associated with higher blood loss and a long period of preoperative fasting, including fluids IFT is dosed to cover the basal daily need for fluids. However, it is not clear whether this fluid dose is optimal. Surgery is a stress factor that leads, among other things, to damage of the endothelial glycocalyx (EG). EG binds a significant amount of plasma, which is released during EG destruction and causes relative hemodilution.

Isovolumic hemodilution is an established intraoperative procedure that serves to better control bleeding in procedures where bleeding is expected. However, partial hemodilution occurs even with standard IFT, and even when fluids are hardly given at all. Flow parameters in microcirculation have not yet been described depending on IFT conduction. The parameters of the microcirculation reflect its functioning, which will consequently affect the postoperative phase of the patient's moaning and clinical outcome.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location status: Recruiting

Location contact

David Astapenko, MD, PhD

CONTACT

[email protected]

+420495833218

About this study

Intraoperative fluid therapy (IFT) is an integral part of anesthesia care during surgery. Its main indication is the optimization of oxygen supply to the tissues. IFT is tailored to the surgical performance, blood loss, and patient (comorbidities, length of preoperative fasting, hydration level, volemia status). For elective surgery that is not associated with higher blood loss (< 200 ml) and a long period of preoperative fasting, including fluids (fluids per os < 2 hours before the procedure), IFT is dosed to cover the basal daily need for fluids (approx. 1-2 ml) /kg.hour-1). However, it is not clear whether this fluid intake is optimal. Surgery is a stress factor that leads, among other things, to damage of the endothelial glycocalyx (EG), which is a thin carbohydrate layer on the endoluminal side of endothelial cells, which is of fundamental importance for the physiology of microcirculation and tissue metabolism. EG also binds a significant amount of plasma (estimated up to 1.7 liters), which is released during EG destruction and causes relative hemodilution.

Isovolumic hemodilution is an established intraoperative procedure that serves to better control bleeding in procedures where bleeding is expected (e.g. cardiac surgery using an extracorporeal circuit or vascular surgery). However, partial hemodilution occurs even with standard IFT, and even when fluids are hardly given at all. Flow parameters in microcirculation have not yet been described depending on IFT conduction. The parameters of the microcirculation reflect its functioning, which will consequently affect the postoperative phase of the patient's moaning and clinical outcome.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • elective recumbent and laparoscopic surgery
  • informed consent

Exclusion criteria

  • blood loss over 250 ml
  • hemodynamic instability requiring noradrenaline infusion

Treatment and study plan

Crystalloid solutions

Drug

Locally approved crystalloid solution will be given at the predefined infusion rate

Primary outcomes

  1. Sublingual microcirculation profile

    Time frame: 1 hour

    During one hour four measurements each 20 minutes will take place. Recordings will be assessed automatically by specialised software. Microcirculatory parameters of interest are:

    capillary density, De Backer score, perfused capillary density and proportion of perfused vessels.

    Capillary density comes in mm/mm2 and the higher number the better, there is not approved median number.

    De Backer score is derived from capillary density and it is without dimension. Perfused capillary density signifies a percent of perfused vessels and it is in %. Normal values in healthy adults are around 90 %.

Study contacts

Contact information is provided by the study sponsor or research team.

David Astapenko, MD, PhD

CONTACT

[email protected]

+420495833218

Sponsors and collaborators

Lead sponsor

University Hospital Hradec Kralove

Other

Registry information

Official study title

The Impact of Intra-operative Fluid Infusion Rate on Hemodilution and Microcirculation Prospective Observational Pilot Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 4, 2022
Registry last updated
Mar 27, 2025

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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