Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During Craniotomy: a Randomized Controlled Trial

Study Overview
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Brief Summary
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Fluid management during neurosurgery presents a special clinical agenda. Volume overload can have detrimental effects on intracranial pressure by increasing either cerebral blood volume or hydrostatically driven cerebral edema formation. On the other hand, an overt restrictive fluid strategy may risk hemodynamic instability. Recently, dynamic fluid responsiveness parameters such as stroke volume variation (SVV) have been shown as a more precise parameters for fluid management including in neurosurgical patients. The threshold of SVV is reported about 10-15%. In this study, the investigators aim to using two SVV threshold to conduct intraoperative fluid therapy for craniotomy. Randomization will be generated by computer sampling. One of the two groups of patients will be managed with fluid bolus to keep intraoperative SVV <10% presenting the normovolemia group. The other group of patients will be kept intraoperative SVV <18% which is slightly above previously reported SVV threshold upper limit. The second group thus presents the restrictive group. Clinical outcomes, laboratory analysis including S100-B for neuronal damage and neutrophil gelatinase-associated lipocalin (NGAL) for acute kidney injury, will be compared.

Official Title
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Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During Craniotomy: a Randomized Controlled Trial

Conditions
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Supratentorial Neoplasms, Brain Tumor, Primary, Craniotomy

Intervention / Treatment
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* Drug: Intravenous colloid bolus with Voluven


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Supratentorial brain tumor receiving elective craniotomy BMI between 18.5-27.0 kg.m-2 Exclusion Criteria: Cardiac dysfunction, such as coronary artery diseases; atrial fibrillation; NYHA class II Renal dysfunction, eGFR< 60 ml.min-1.1.73m-2 Pulmonary cormorbidity, such as COPD

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normovolemic group (keeping SVV<10% in supine; <15% in prone)<br>The anesthesiologist will infuse Voluven (Fresenius Kabi, Bad Homburg, Germany) 250 ml if stroke volume variation is over 10% during the surgery to keep the normovolemia. If total Voluven use is over 1500ml and then the anesthesiologist will infuse Saline 250 ml instead. The maintenance of basal fluid, criteria to use inotropes (If cardiac index is below 2.5 l/min/m2 ) are the same standards in the both groups. | Drug: Intravenous colloid bolus with Voluven<br> <br> |
| Active Comparator: Restricitve group (keeping SVV < 18% in supine; <23% in prone)<br>The anesthesiologist will infuse Voluven (Fresenius Kabi, Bad Homburg, Germany) 250 ml if stroke volume variation is over 18% during the surgery to keep the normovolemia. If total Voluven use is over 1500ml and then the anesthesiologist will infuse Saline 250 ml instead. The maintenance of basal fluid, criteria to use inotropes (If cardiac index is below 2.5 l/min/m2 ) are the same standards in the both groups. | Drug: Intravenous colloid bolus with Voluven<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum S100B protein |  | Changes from preoperative to postoperative day 2 | 
| serum NGAL level |  | Changes from preoperative to postoperative day 2. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks | 
| Postoperative complications rate |  | participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks | 
| Total intraoperative intravenous fluid administrated |  | During the surgical time, an expected average of 3 to 5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluid therapy, neurosurgery