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| Name | Class |
|---|---|
| Military University Hospital, Prague | OTHER |
| Zlin Regional Hospital | UNKNOWN |
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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.
Patients undergoing major surgery are at risk for inadequate intravascular volumes and therefore inadequate tissue perfusion and oxygen delivery. Especially in neurosurgery, fluid management can be a challenge. In many surgical areas, such as orthopedics, gynecology or abdominal surgery, goal-directed fluid therapy is used with the aim of reducing postoperative complications. Current knowledge regarding effect of the goal-directed therapy in neurosurgery is limited.
This is a multicenter, prospective, randomized, controlled study that compares two approaches to fluid management in elective brain surgery. Patients scheduled for brain surgery will be screened whether they meet the inclusion criteria and after obtaining informed consent, the patient will be randomized to one of two study arms.
In the first (standard) arm standard vital signs monitoring will be used during the surgery and perioperative fluid management and administration of vasopressors will be guided by the decision of the attending anaesthetist.
In the second (GDT) arm perioperative fluid management and administration of vasopressors will be guided by a non-invasive hemodynamic monitor STARLINK™SV, which will be introduced in addition to standard monitoring.
The primary outcome is the incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI) in both study groups and their comparison. The secondary outcome is to investigate the efficacy and additional safety parameters of GDHT guided by non-invasive advanced hemodynamic monitoring versus hemodynamic management guided by standard vital signs monitoring.
This study will enroll 140 patients in total, 70 in each group. After completion of enrolment of patients the statistical analysis will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard monitoring | Active Comparator | In this arm standard monitoring of vital signs will be used during operation. |
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| Goal-Directed Therapy | Experimental | A non-invasive hemodynamic monitor STARLINK™SV will be used in addition to standard monitoring. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard monitoring | Other | Administration of fluids and vasoactive drugs guided by standard vital signs monitoring |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
| 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. | 28 days |
| Number of participants with arrhythmia | Defined as electrocardiograph (ECG) evidence of cardiac rhythm disturbance. AESI will be analysed descriptively and compared between study groups. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of surgery | Duration of surgery (min) - will be analysed descriptively and compared between study arms | During the surgery (hours) |
| 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. |
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Inclusion Criteria:
Subjects will be eligible for the trial if they meet all of the following criteria:
Exclusion Criteria:
Subjects will not be eligible for the trial if they meet any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roman Gál, prof. | Contact | +420 532 233 850 | gal.roman@fnbrno.cz | |
| Ondřej Hrdý, M.D. | Contact | +420 532 232 009 | hrdy.ondrej@fnbrno.cz |
| Name | Affiliation | Role |
|---|---|---|
| Veronika Kočí, M.D. | Brno University Hospital | Study Chair |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 29, 2024 | Jul 2, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000074388 | Early Goal-Directed Therapy |
| ID | Term |
|---|---|
| D003422 | Critical Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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Parallel Assignment
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| Goal-Directed Therapy | Other | Administration of fluids and vasoactive drugs guided by non-invasive haemodynamic monitoring |
|
| 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. |
| 28 days |
| Number of participants with cardiogenic pulmonary oedema | Defined as evidence of fluid accumulation in the alveoli due to poor cardiac function. AESI will be analysed descriptively and compared between study groups. | 28 days |
| Number of participants with deep vein thrombosis (DVT) | A new blood clot or thrombus within the venous system. Appropriate diagnostic tests include ultrasound, venography, CT or MRI venography. Plasma D-dimer measurement is not recommended as a diagnostic test in the first three weeks following surgery. AESI will be analysed descriptively and compared between study groups. | 28 days |
| Number of participants with pulmonary embolism (PE) | A new blood clot or thrombus within the pulmonary arterial system. AESI will be analysed descriptively and compared between study groups. | 28 days |
| Number of participants with gastrointestinal bleed | Clinical or endoscopic evidence of blood in the gastrointestinal tract. AESI will be analysed descriptively and compared between study groups. | 28 days |
| Number of participants with infection, source uncertain | Infection where there is strong clinical suspicion of infection but the source has not been confirmed because clinical information suggests more than one possible site, meeting two or more of the following criteria: core temperature < 36°C or >38°C; white cell count >12×109 l-1 or < 4×109 l-1, respiratory rate >20 breaths per minute or PaCO2 < 4.7 kPa (35mmHg); pulse rate >90 beats per minute. AESI will be analysed descriptively and compared between study groups. | 28 days |
| Number of participants with laboratory confirmed bloodstream infection | Infection which meets at least one of the following criteria which should not be related to infection at another site:
| 28 days |
| Number of participants with myocardial infarction | Defined as increase in serum cardiac biomarker values (preferably cardiac troponin) with at least one value above the 99th percentile upper reference limit and at least one of the following criteria: symptoms of ischaemia; new or presumed new significant ST segment or T wave ECG changes or new left bundle branch block; development of pathological Q waves on ECG; radiological or echocardiographic evidence of new loss of viable myocardium or new regional wall motion abnormality; identification of an intracoronary thrombus at angiography or autopsy. AESI will be analysed descriptively and compared between study groups. | 28 days |
| Number of participants with pneumonia | Definition: Two or more serial chest radiographs with at least one of the following (one radiograph is sufficient for patients with no underlying pulmonary or cardiac disease):
(1) fever (>38°C) with no other recognised cause (2) leucopaenia (white cell count < 4 × 109 l-1) or leucocytosis (white cell count >12 × 109 l-1) (3) for adults >70 years old, altered mental status with no other recognised cause; and at least two of the following:
AESI will be analysed descriptively and compared between study groups. | 28 days |
| Number of participants with paralytic ileus | Failure to tolerate solid food or defecate for three or more days after surgery. AESI will be analysed descriptively and compared between study groups. | 28 days |
| Number of participants with postoperative haemorrhage | Blood loss within 72 h after the start of surgery which would normally result in transfusion of blood. AESI will be analysed descriptively and compared between study groups. | 28 days |
| Number of participants with stroke | An embolic, thrombotic or haemorrhagic cerebral event with persistent residual motor, sensory or cognitive dysfunction (e.g. hemiplegia, hemiparesis, aphasia, sensory deficit, impaired memory). AESI will be analysed descriptively and compared between study groups. | 28 days |
| Number of participants with brain oedema | Brain oedema confirmed on CT or MRI scan. AESI will be analysed descriptively and compared between study groups. | 28 days |
| Number of participants with surgical site infection (superficial) | A superficial incisional surgical site infection is defined as one which meets the following criteria:
AESI will be analysed descriptively and compared between study groups. | 28 days |
| Number of participants with surgical site infection (deep) |
AESI will be analysed descriptively and compared between study groups. | 28 days |
| Number of participants with surgical site infection (organ/space) | Infection which involves any part of the body excluding the fascia or muscle layers and meets the following criteria:
| 28 days |
| Number of participants with urinary tract infection | A positive urine culture of ≥105 colony forming units ml-1 with no more than two species of micro-organisms, and with at least one of the following symptoms or signs: fever (>38°C), urgency, frequency, dysuria, suprapubic tenderness, costovertebral angle pain or tenderness with no other recognised cause. Each of these criteria should be identified within a 24-h period. AESI will be analysed descriptively and compared between study groups. | 28 days |
| Days (up to 28) |
| 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. | Days (up to 28) |
| 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. | 28 days after randomization |
| Adverse events | Descriptive analysis of the incidence of any adverse events and reactions | 28 days |
| Hemodynamic characteristics - MAP (Mean arterial pressure) | MAP (mmHg; before, after surgery) will be analysed descriptively and compared between study arms. | During the surgery and 24 hours post operation |
| Hemodynamic characteristics - HR (Heart rate) | HR (Bpm; before, after surgery) will be analysed descriptively and compared between study arms. | During the surgery and 24 hours post operation |
| Hemodynamic characteristics - SVV (Stroke volume variation) measured by The Starling™ SV System | SVV (%; before, after surgery will be analysed descriptively and compared between study arms. | During the surgery (hours) |
| Hemodynamic characteristics - number of episodes of hypotension | Number of episodes of hypotension will be analysed descriptively and compared between study arms. | During the surgery and 24 hours post operation |
| Hemodynamic characteristics - number of vasopressor administrations | Number of vasopressor administrations will be analysed descriptively and compared between study arms. | During the surgery and 24 hours post operation |
| Hemoglobin | Hemoglobin (g/l; before, after surgery and 24 hours after surgery) - will be analysed descriptively and compared between study arms. | 24 hours |
| Plasma lactate level | Plasma lactate level (mmol/L; before, after surgery and 24 hours after surgery) will be analysed descriptively and compared between study arms. | 24 hours |
| Volume of blood loss | Volume of blood loss (ml/kg; during surgery and in the 24-hour postoperative period) will be analysed descriptively and compared between study arms. | During the surgery and 24 hours post operation |
| Urinary output | Urinary output (ml/kg/hod; during surgery and in the 24-hour postoperative period) will be analysed descriptively and compared between study arms. | During the surgery and 24 hours post operation |
| Number of administered units of packed RBC (Red blood cell) | Number of administered units of packed RBC (during surgery and in the 24-hour postoperative period) will be analysed descriptively and compared between study arms. | During the surgery and 24 hours post operation |
| Number of subjects receiving transfusion | Number of subjects receiving transfusion (during surgery and in the 24-hour postoperative period) will be analysed descriptively and compared between study arms. | During the surgery and 24 hours post operation |
| Crystalloid and colloid solutions consumption | Crystalloid and colloid solutions consumption (type and total volume of infusion during surgery and in the 24-hour postoperative period) will be analysed descriptively and compared between study arms. | During the surgery and 24 hours post operation |
| Boluses of crystalloids | Boluses of crystalloids (ml; during surgery) will be analysed descriptively and compared between study arms. | During the surgery and 24 hours post operation |