This study aims to assess the safety and efficacy of GDHT using the non-invasive Starling™ SV System in elective neurosurgery. The tested group of patients (n=70) will be compared with a control group (n=70), where hemodynamic management will be guided by standard vital signs monitoring.
Age ≥ 18 years
Elective brain surgery with an expected duration ≥ 2 h
Category 1-3 according to the ASA (American Society of Anesthesiologists) Physical Status Classification
Lateral or supine operative position
Category 4 according to the ASA Physical Status Classification
Surgery for traumatic brain injury or acute hemorrhagic stroke
Awake brain surgery
Osmotherapy before surgery (with the exception of prophylactic administration of osmotic agents according to institutional standards)
Parallel
Standard monitoring
Other interventionAdministration of fluids and vasoactive drugs guided by standard vital signs monitoring
Goal-Directed Therapy
Other interventionAdministration of fluids and vasoactive drugs guided by non-invasive haemodynamic monitoring
Number of participants with acute kidney Injury
Defined according to Kidney Disease Improving Global Outcomes (KDIGO) guidelines: Stage 1: serum creatinine 1.5-1.9 times baseline value within 7 days or ≥27 µmol l-1 (0.3 mg dl-1) increase within 48 h; urine output ≤0.5 ml kg-1 h-1 for 6-12 h Stage 2: serum creatinine 2.0-2.9 times baseline value within 7 days; urine output ≤0.5 ml kg-1 h-1 for 12 h Stage 3: serum creatinine 3.0 times baseline within 7 days or increase in serum creatinine to ≥354 µmol l-1 (≥4.0 mg.dl1 with an acute rise of \> 44 mmol l-1 (0.5 mg/dl-1) or initiation of renal replacement therapy or in patients \< 18 years, decrease in eGFR (estimated Glomerular Filtration Rate) to \< 35 ml min-1 per 1.73m2; urine output ≤0.3 ml kg1 h-1 for 24 h or anuria for 12 h. AESI will be analysed descriptively and compared between study groups.
Number of participants with acute Respiratory Distress Syndrome (ARDS)
The Berlin definition of Respiratory Distress Syndrome: Timing: Within one week of a known clinical insult or new or worsening respiratory symptoms and Chest imaging: Bilateral opacities not fully explained by effusions, lobar/lung collapse or nobles and Origin of oedema: Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (e.g. echocardiography) to exclude hydrostatic oedema if no risk factor is presented and Oxygenation disorder: mild: PaO2 (partial pressure of oxygen in arterial blood):FIO2 (Fraction of Inspired Oxygen) between 26.7 and 40.0 kPa (kilopascal) (200-300mmHg) with PEEP (Positive End-Expiratory Pressure) or CPAP (Continuous Positive Airway Pressure) ≥5 cmH2O (centimeters of water). Moderate: PaO2:FIO2 between 13.3 and 26.6 kPa (100- 200 mmHg) with PEEP ≥5 cmH2O. Severe: PaO2:FIO2 ≤13.3 kPa (100mmHg) with PEEP ≥5 cmH2O. AESI will be analysed descriptively and compared between study groups.
Number of participants with arrhythmia
Defined as electrocardiograph (ECG) evidence of cardiac rhythm disturbance. AESI will be analysed descriptively and compared between study groups.
Number of participants with cardiac arrest
Cessation of cardiac mechanical activity, as confirmed by the absence of signs of circulation. AESI will be analysed descriptively and compared between study groups.
Duration of surgery
Duration of surgery (min) - will be analysed descriptively and compared between study arms
Length of hospital stay
LOS (Length of stay, day of admission - day of discharge will be counted as 1 day) - will be calculated as a number of days between admission and discharge, analysed descriptively and compared between study groups.
ICU length of stay
ICU LOS (day of admission - day of discharge will be counted as 1 day) - will be calculated as a number of days between admission to the ICU and discharge from the ICU, analysed descriptively and compared between study groups.
28-day mortality
28-day mortality (number of patients who are not alive 28 days after randomization) will be evaluated as a number and percentage of patients who are not alive 28 days after randomization and compared between study arms.
Click on the lead sponsor to view all of their trials.
Brno University Hospital
Lead sponsor
Military University Hospital, Prague
Collaborator
Zlin Regional Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
