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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02113358
Other study ID # 201312116RINC
Secondary ID
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


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
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