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Recruiting NCT05606536

The Impact of Intra-operative Fluid Infusion Rate on Microcirculation

No phase Interventional Fluid Therapy Microcirculation Hemodilution

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Crystalloid Solutions.
Who it may be relevant to
Registry conditions: Fluid Therapy, Microcirculation, Hemodilution. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Drug Crystalloid Solutions
    Locally approved crystalloid solution will be given at the predefined infusion rate

Primary outcome measures

  • Sublingual microcirculation profile [Time frame: 1 hour]

Eligibility criteria

Inclusion criteria

  • elective recumbent and laparoscopic surgery
  • informed consent

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • University Hospital Hradec Kralove — Hradec Králové

Identifiers

NCT: NCT05606536 · CooperatioUK_MIC_HEM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗