The Impact of Intra-operative Fluid Infusion Rate on Microcirculation

NCT ID: NCT05606536

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2025-12-31

Brief 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.

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.

Conditions

Fluid Therapy; Microcirculation; Hemodilution

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

10 % hemodilution

Recumbent surgery:

• infusion rate in first 20 minutes: 15 ml/kg/h
• infusion rate after 20 minutes: 2,6 ml/kg/h

Laparoscopic surgery:

• infusion rate in first 20 minutes: 16 ml/kg/h
• infusion rate after 20 minutes: 0,8 ml/kg/h

Group Type: EXPERIMENTAL

Crystalloid Solutions

Intervention Type: DRUG

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

20 % hemodilution

Recumbent surgery:

• infusion rate in first 20 minutes: 26 ml/kg/h
• infusion rate after 20 minutes: 3,4 ml/kg/h

Laparoscopic surgery:

• infusion rate in first 20 minutes: 28 ml/kg/h
• infusion rate after 20 minutes: 1,6 ml/kg/h

Group Type: EXPERIMENTAL

Crystalloid Solutions

Intervention Type: DRUG

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

30 % hemodilution

Recumbent surgery:

• infusion rate in first 20 minutes: 38 ml/kg/h
• infusion rate after 20 minutes: 5,1 ml/kg/h

Laparoscopic surgery:

• infusion rate in first 20 minutes: 44 ml/kg/h
• infusion rate after 20 minutes: 2,4 ml/kg/h

Group Type: EXPERIMENTAL

Crystalloid Solutions

Intervention Type: DRUG

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

Standart care

Infusion rate based upon the standard care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Crystalloid Solutions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• elective recumbent and laparoscopic surgery
• informed consent

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Hradec Kralove

OTHER

Sponsor Role: lead

Responsible Party

David Astapenko, MD, PhD

Deputy Head for Science and Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Hradec Kralove

Hradec Králové, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

David Astapenko, MD, PhD

Role: CONTACT

david.astapenko@fnhk.cz

+420495833218

Facility Contacts

David Astapenko, MD, PhD

Role: primary

david.astapenko@fnhk.cz

+420495833218

Other Identifiers

CooperatioUK_MIC_HEM

Identifier Type: -

Identifier Source: org_study_id