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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05606536
Other study ID # CooperatioUK_MIC_HEM
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source University Hospital Hradec Kralove
Contact David Astapenko, MD, PhD
Phone +420495833218
Email david.astapenko@fnhk.cz
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - elective recumbent and laparoscopic surgery - informed consent Exclusion Criteria: - blood loss over 250 ml - hemodynamic instability requiring noradrenaline infusion

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Czechia University Hospital Hradec Kralove Hradec Kralove

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sublingual microcirculation profile 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 %.
1 hour
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