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

National Taiwan University

Status: Unknown

Conditions: Craniotomy; Brain Tumor, Primary; Supratentorial Neoplasms

Treatments: Drug: Intravenous colloid bolus with Voluven

Study type: Interventional

Funder types: Other

Identifiers

NCT02113358

201312116RINC

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Normovolemic group (keeping SVV<10% in supine; <15% in prone)

Experimental group

Description:

1. 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. 2. If total Voluven use is over 1500ml and then the anesthesiologist will infuse Saline 250 ml instead. 3. 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.

Treatment:

Drug: Intravenous colloid bolus with Voluven

Restricitve group (keeping SVV < 18% in supine; <23% in prone)

Active Comparator group

Description:

1. 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. 2. If total Voluven use is over 1500ml and then the anesthesiologist will infuse Saline 250 ml instead. 3. 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.

Treatment:

Drug: Intravenous colloid bolus with Voluven