An interventional study of Hemodynamic management based on invasive fluid responsiveness parameters and Hemodynamic management based on noninvasive cardiac output and SVV measurement in Brain Edema, sponsored by University Hospital Hradec Kralove. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by University Hospital Hradec Kralove · Not applicable, Interventional, and Treatment
The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using invasive measurement SPV/PPV (Aisys GE) and noninvasive haemodynamic measurement (ClarSight, Edwards).
The aim of the study is to optimise fluid management and to reduce perioperative risks during brain surgery. Adequate perioperative management guided by hemodynamic monitoring can help to reduce the risk of complications and thus potentially improve outcomes.
This study compares fluid management algorithms based either on invasive detection of fluid responsiveness using pulse pressure variation (PPV) and systolic pressure variation (SPV) values (Aisys GE monitoring system) in group A, or on noninvasive measurement of haemodynamics (stroke volume variation (SVV), cardiac index (CI) and systemic vascular resistance (SVR) values) (ClearSight, Edwards) in group B.
102 studies on the registry are indexed under Brain Edema; 25 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 62 interventional studies indexed under Brain Edema.
Browse Brain Edema studies →University Hospital Hradec Kralove is the lead sponsor of 49 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid bolus will be applied in case of protocol defined hypotension according to the value of systolic pressure variation SPV (Aisys GE). The value of SPV (tidal volume 6 ml/kg) above 8% will be used to predict fluid responsiveness. In case of fluid responsiveness, bolus of 2ml/kg of Plasmalyte will be given within 10 minutes. Boluses will be repeated in hypotensive patients if fluid responsiveness persists. Norepinephrine will be used in hypotensive patients without predicted fluid responsiveness.
Procedure: Hemodynamic management based on invasive fluid responsiveness parameters
No continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid management and the use of norepinephrine will follow a protocol based on the values of cardiac index level, systemic vascular resistance and systolic volume variation (SVV) (ClearSight, Edwards).
Procedure: Hemodynamic management based on noninvasive cardiac output and SVV measurement
In case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the SPV value more than 8% will be used as a trigger for the bolus of 2 ml/kg of Plasmalyte (Baxter)
In case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the systemic vascular resistance (SVR) value will be used to trigger norepinephrine infusion. In patients with low SVR norepinephrine infusion will be started. In patients with high SVR value either fluid bolus (in patient with SVV value above 8%), or dobutamine infusion (in patients with SVV value below or equal 8%) will be used.
fluid balance difference
the difference between fluid intake and output and losses during surgery will be calculated
Time frame: up to 5 hours after start of operation
mean dose of norepinephrine
mean dose of norepinephrine will be calculated from total delivered dose devided by time of the surgery
Time frame: up to 5 hours after start of operation
level of creatinin
plasma level of creatinin measured on the first postoperative day
Time frame: 24 hours
postoperative lung dysfunction
postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy more than 6 hours postoperatively
Time frame: 1 day
length of postoperative stay
number of days of stay in the hospital after the surgery
Time frame: up to 2 month after surgery
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University Hospital Hradec Kralove