Craniotomy Clinical Trial
Official title:
Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During Craniotomy: a Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | serum S100B protein | Changes from preoperative to postoperative day 2 | No | |
Primary | serum NGAL level | Changes from preoperative to postoperative day 2. | No | |
Secondary | Length of hospital stay | participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks | No | |
Secondary | Postoperative complications rate | participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks | No | |
Secondary | Total intraoperative intravenous fluid administrated | During the surgical time, an expected average of 3 to 5 hours | No |
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