Clinical trial

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

Name
CooperatioUK_MIC_HEM
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. 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.
Trial arms
Trial start
2022-10-01
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Recruiting
Treatment
Crystalloid Solutions
Locally approved crystalloid solution will be given at the predefined infusion rate
Arms:
10 % hemodilution, 20 % hemodilution, 30 % hemodilution
Size
80
Primary endpoint
Sublingual microcirculation profile
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-05-08

1 organization

1 product

3 indications

Indication
Fluid Therapy
Indication
Hemodilution