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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02113358
Enrollment
80
Registered
2014-04-14
Start date
2014-04-30
Completion date
2015-05-31
Last updated
2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor, Primary, Craniotomy, Supratentorial Neoplasms

Keywords

fluid therapy, neurosurgery

Brief summary

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.

Interventions

DRUGIntravenous colloid bolus with Voluven

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
serum S100B proteinChanges from preoperative to postoperative day 2
serum NGAL levelChanges from preoperative to postoperative day 2.

Secondary

MeasureTime frame
Length of hospital stayparticipants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks
Postoperative complications rateparticipants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks
Total intraoperative intravenous fluid administratedDuring the surgical time, an expected average of 3 to 5 hours

Countries

Taiwan

Contacts

Primary ContactChia-Chen Liu
a0918994038@yahoo.com.tw+886-2-23123456

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026