Clinical trial NCT02113358: Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During Craniotomy: a Randomized Controlled Trial
Official title: Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During Craniotomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Supratentorial Neoplasms
Brain Tumor, Primary
Craniotomy
Keywords: fluid therapy
neurosurgery
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-04-14
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: serum S100B protein
timeFrame: Changes from preoperative to postoperative day 2
measure: serum NGAL level
timeFrame: Changes from preoperative to postoperative day 2.
Secondary outcomes:
measure: Length of hospital stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks
measure: Postoperative complications rate
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks
measure: Total intraoperative intravenous fluid administrated
timeFrame: During the surgical time, an expected average of 3 to 5 hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital Anesthesiology Department
name: Chun-Yu Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu CY, Lin YS, Tseng HM, Cheng HL, Lee TS, Lin PL, Chou WH, Cheng YJ. Comparison of two stroke volume variation-based goal-directed fluid therapies for supratentorial brain tumour resection: a randomized controlled trial. Br J Anaesth. 2017 Nov 1;119(5):934-942. doi: 10.1093/bja/aex189.