Effects of GDHT (Goal Directed Hemodynamic Therapy) Using a Non-invasive Hemodynamic Monitoring in Elective Neurosurgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard monitoring, Goal-Directed Therapy.
- Who it may be relevant to
- Registry conditions: Surgery Complications. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Goal-directed Fluid Management Guided by a Non-invasive Device on the Incidence of Postoperative Complications in Neurosurgery: a Multicenter, Prospective, Randomized, Controlled Study
Overview
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.
Detailed description
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.
Interventions
- Other Standard monitoring
Administration of fluids and vasoactive drugs guided by standard vital signs monitoring - Other Goal-Directed Therapy
Administration of fluids and vasoactive drugs guided by non-invasive haemodynamic monitoring
Primary outcome measures
- Number of participants with acute kidney Injury [Time frame: 28 days]
- Number of participants with acute Respiratory Distress Syndrome (ARDS) [Time frame: 28 days]
- Number of participants with arrhythmia [Time frame: 28 days]
- Number of participants with cardiac arrest [Time frame: 28 days]
- Number of participants with cardiogenic pulmonary oedema [Time frame: 28 days]
- Number of participants with deep vein thrombosis (DVT) [Time frame: 28 days]
- Number of participants with pulmonary embolism (PE) [Time frame: 28 days]
- Number of participants with gastrointestinal bleed [Time frame: 28 days]
- Number of participants with infection, source uncertain [Time frame: 28 days]
- Number of participants with laboratory confirmed bloodstream infection [Time frame: 28 days]
Secondary outcome measures (12)
- Duration of surgery [Time frame: During the surgery (hours)]
- Length of hospital stay [Time frame: Days (up to 28)]
- ICU length of stay [Time frame: Days (up to 28)]
- 28-day mortality [Time frame: 28 days after randomization]
- Adverse events [Time frame: 28 days]
- Hemodynamic characteristics - MAP (Mean arterial pressure) [Time frame: During the surgery and 24 hours post operation]
- Hemodynamic characteristics - HR (Heart rate) [Time frame: During the surgery and 24 hours post operation]
- Hemodynamic characteristics - SVV (Stroke volume variation) measured by The Starling™ SV System [Time frame: During the surgery (hours)]
- Hemodynamic characteristics - number of episodes of hypotension [Time frame: During the surgery and 24 hours post operation]
- Hemodynamic characteristics - number of vasopressor administrations [Time frame: During the surgery and 24 hours post operation]
- Hemoglobin [Time frame: 24 hours]
- Plasma lactate level [Time frame: 24 hours]
Eligibility criteria
Inclusion criteria
Subjects will be eligible for the trial if they meet all of the following criteria:
- 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
- Signed the relevant informed consent form
Exclusion criteria
Subjects will not be eligible for the trial if they meet any of the following criteria:
- 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)
- Unavailability of hemodynamic monitoring data
- Cardiac arrhythmia with irregular cardiac rhythm
- Known hypersensitivity to the active substance or to any of the excipients of IMP (Investigational Medicinal Product)
- Pregnancy and lactation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07101991 · CT0012025