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Study on Fluid Management to Reduce Post-Surgery Complications in Brain Surgery Patients Using Magnesium Chloride, Potassium Chloride, and Sodium Chloride

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients undergoing elective neurosurgery for unspecified brain conditions. The study aims to explore the effects of a specific approach to managing fluids in the body, known as goal-directed fluid management, which is guided by a non-invasive device called the Starling™ SV System. This approach is being tested to see if it can reduce complications that may occur after surgery.

Two different solutions for infusion will be used in this study. The first is called Isolyte infuzní roztok, which contains substances like magnesium chloride hexahydrate, potassium chloride, sodium chloride, and sodium acetate trihydrate. The second solution is Gelaspan 4%, which includes the same substances as Isolyte, with the addition of calcium chloride dihydrate and succinylated gelatin. These solutions are administered through an intravenous infusion, which means they are given directly into a vein.

Participants in the study will be randomly assigned to receive either one of these solutions or a placebo during their surgery. The study will monitor the incidence of any complications after surgery, as well as other factors like the duration of surgery, time spent in the hospital, and any adverse reactions. The trial is expected to continue until 2027, with the aim of improving outcomes for patients undergoing brain surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after signing the informed consent form. Eligibility includes being 18 years or older, undergoing elective brain surgery expected to last at least 2 hours, and meeting specific health criteria.

  2. Step 2

    Pre-surgery preparation

    Before surgery, preparation involves ensuring the patient is in the correct lateral or supine position. The non-invasive Starling™ SV System will be used to guide fluid management during the procedure.

  3. Step 3

    Surgery and fluid management

    During surgery, fluid management is guided by the Starling™ SV System. Two types of infusion solutions may be used: Isolyte infusion solution and Gelaspan 4% infusion solution. These solutions are administered intravenously to maintain fluid balance and support bodily functions.

  4. Step 4

    Post-surgery monitoring

    After surgery, monitoring focuses on the incidence of postoperative complications. Key observations include adverse events, blood pressure, heart rate, and fluid levels. The duration of surgery, length of hospital stay, and any additional treatments are recorded.

  5. Step 5

    Follow-up and data collection

    Follow-up involves assessing recovery and any complications within 28 days post-surgery. Data collected includes the volume of blood loss, urinary output, and any transfusions or additional fluid administrations.

Who can join the trial?

5 criteria

  • Must be **18 years old** or older.
  • Scheduled for **elective brain surgery** that is expected to last **2 hours or more**. Elective surgery means it is planned in advance and not an emergency.
  • Must be in **Category 1-3** according to the **ASA Physical Status Classification**. This is a system used by doctors to assess the fitness of patients before surgery. Category 1 means a healthy patient, Category 2 means a patient with mild systemic disease, and Category 3 means a patient with severe systemic disease.
  • Surgery must be performed in a **lateral or supine position**. Lateral means lying on the side, and supine means lying on the back.
  • Must have **signed the informed consent form**, which means you agree to participate in the study after being informed about all the details and risks.

Who cannot join the trial?

5 criteria

  • Patients who are not scheduled for **elective neurosurgery**. This means surgery that is planned in advance and not an emergency.
  • Patients who are not undergoing surgery for **unspecified brain conditions**. This refers to brain issues that are not clearly defined.
  • Patients who are outside the age range of 18 to 65 years old.
  • Patients who are not part of the specified clinical trial group. This means they do not meet the specific group requirements for the study.
  • Patients who are considered part of a **vulnerable population**. This includes groups who may need special protection or care.
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Investigated drugs

Starling™ SV System is a non-invasive device used in this clinical trial to guide goal-directed fluid management. The system helps doctors monitor and manage the fluid levels in patients undergoing neurosurgery. By using this device, the trial aims to reduce the number of complications that can occur after surgery by ensuring that patients receive the right amount of fluids during their operation.

What is already known about the treatment

Starling™ SV System – This is a non-invasive device used to guide goal-directed fluid management during neurosurgery. It is currently being studied in clinical trials to assess its effectiveness in reducing postoperative complications in patients undergoing brain surgery. The main therapeutic indication is to optimize fluid management in neurosurgical procedures. The device works by measuring stroke volume and other hemodynamic parameters to guide fluid therapy decisions. It falls under the category of medical devices used for hemodynamic monitoring.

Investigated diseases

Unspecified Brain Conditions – This term refers to various disorders affecting the brain that are not specifically identified. These conditions can involve abnormalities in brain structure or function, leading to symptoms such as headaches, seizures, or cognitive changes. The progression of these conditions can vary widely depending on the underlying cause and may involve gradual worsening of symptoms or sudden changes. Treatment often involves neurosurgical intervention to address the specific issues within the brain. The goal of surgery is typically to alleviate symptoms and prevent further complications. The exact nature and progression of these conditions depend on the specific diagnosis made by healthcare professionals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511153-21-00Protocol codeNCHGDTEstimated enrolment140 patientsSponsorFakultni Nemocnice Brno

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