The Impact of Intra-operative Fluid Infusion Rate on Microcirculation

NCT05606536 | Recruiting

• 1 other identifier: CooperatioUK_MIC_HEM
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Therapy; Microcirculation; Hemodilution

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

10 % hemodilution

EXPERIMENTAL

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

Drug: Crystalloid Solutions

20 % hemodilution

EXPERIMENTAL

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

Drug: Crystalloid Solutions

30 % hemodilution

EXPERIMENTAL

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

Drug: Crystalloid Solutions

Standart care

NO INTERVENTION

Infusion rate based upon the standard care.

Interventions

Crystalloid Solutions DRUG

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

10 % hemodilution; 20 % hemodilution; 30 % hemodilution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective recumbent and laparoscopic surgery
• informed consent

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

RECRUITING

MeSH Terms

Interventions

Crystalloid Solutions

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

David Astapenko, MD, PhD

CONTACT

+420495833218; david.astapenko@fnhk.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head for Science and Research

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 4, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)