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Trial Title:
Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During Craniotomy: a Randomized Controlled Trial
NCT ID:
NCT02113358
Condition:
Supratentorial Neoplasms
Brain Tumor, Primary
Craniotomy
Conditions: Official terms:
Brain Neoplasms
Supratentorial Neoplasms
Conditions: Keywords:
fluid therapy
neurosurgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Intravenous colloid bolus with Voluven
Arm group label:
Normovolemic group (keeping SVV<10% in supine; <15% in prone)
Arm group label:
Restricitve group (keeping SVV < 18% in supine; <23% in prone)
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Wu Chun-Yu
Phone:
+886-972653376
Email:
longersolo@gmail.com
Investigator:
Last name:
Chun-Yu Wu, MD
Email:
Principal Investigator
Start date:
April 2014
Completion date:
May 2015
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02113358
