Fluid TherapyNCT05606536
The Impact of Intra-operative Fluid Infusion Rate on Microcirculation
A study testing Crystalloid Solutions in people with Fluid Therapy and Microcirculation, run by University Hospital Hradec Kralove at 1 site in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Therapy, Microcirculation, Hemodilution
- What is being tested?
- Crystalloid Solutions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Oct 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective recumbent and laparoscopic surgery
- informed consent
Who cannot join
- blood loss over 250 ml
- hemodynamic instability requiring noradrenaline infusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Hradec Kralove
Hradec Králové, 50005
David Astapenko, MD, PhD, +420495833218, david.astapenko@fnhk.cz
About this study
Official title: The Impact of Intra-operative Fluid Infusion Rate on Hemodilution and Microcirculation Prospective Observational Pilot 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. 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.
Read the 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
- Being tested
- Crystalloid Solutions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crystalloid SolutionsDrug
Locally approved crystalloid solution will be given at the predefined infusion rate
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Crystalloid Solutions |
| Standart care | No intervention | Infusion rate based upon the standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 %.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start1 Oct 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Astapenko, MD, PhD, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606536
- Sponsor's protocol ID
- CooperatioUK_MIC_HEM
- Status last verified
- Mar 2025
- First submitted
- 26 Oct 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intra-operative Fluid Infusion Rate on Hemodilution and Microcirculation Prospective Observational Pilot Study
- ClinicalTrials.gov ID
- NCT05606536
- Acronym / sponsor ID
- CooperatioUK_MIC_HEM
- Conditions
- Fluid Therapy, Microcirculation, Hemodilution
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10 % hemodilution | Experimental | Drug: Crystalloid SolutionsRecumbent 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 |
| 20 % hemodilution | Experimental | Drug: Crystalloid SolutionsRecumbent 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 |
| 30 % hemodilution | Experimental | Drug: Crystalloid SolutionsRecumbent 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 |
| Standart care | No intervention | –Infusion rate based upon the standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective recumbent and laparoscopic surgery
- informed consent
Key exclusion criteria (2 listed)
- blood loss over 250 ml
- hemodynamic instability requiring noradrenaline infusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crystalloid SolutionsLocally approved crystalloid solution will be given at the predefined infusion rate | Drug | 10 % hemodilution, 20 % hemodilution, 30 % hemodilution |
Primary outcome
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 %.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crystalloid Solutions in people with Fluid Therapy and Microcirculation, run by University Hospital Hradec Kralove at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Astapenko, MD, PhD (+420495833218, david.astapenko@fnhk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sublingual microcirculation profile (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.