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

Craniotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02113358
• Other study ID #: 201312116RINC
• Status: Recruiting
• Phase: N/A
• First received: April 8, 2014
• Last updated: December 2, 2014
• Start date: April 2014
• Est. completion date: May 2015

Study information

• Verified date: December 2014
• Source: National Taiwan University Hospital
• Contact: Chia-Chen Liu
• Phone: +886-2-23123456
• Email: a0918994038[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor, Primary
• Craniotomy
• Supratentorial Neoplasms

Intervention

Drug:
• Intravenous colloid bolus with Voluven

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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