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

Primary Purpose

Supratentorial Neoplasms, Brain Tumor, Primary, Craniotomy

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Intravenous colloid bolus with Voluven
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Supratentorial Neoplasms focused on measuring fluid therapy, neurosurgery

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Normovolemic group (keeping SVV<10% in supine; <15% in prone)

Restricitve group (keeping SVV < 18% in supine; <23% in prone)

Arm Description

The anesthesiologist will infuse Voluven (Fresenius Kabi, Bad Homburg, Germany) 250 ml if stroke volume variation is over 10% during the surgery to keep the normovolemia. If total Voluven use is over 1500ml and then the anesthesiologist will infuse Saline 250 ml instead. The maintenance of basal fluid, criteria to use inotropes (If cardiac index is below 2.5 l/min/m2 ) are the same standards in the both groups.

The anesthesiologist will infuse Voluven (Fresenius Kabi, Bad Homburg, Germany) 250 ml if stroke volume variation is over 18% during the surgery to keep the normovolemia. If total Voluven use is over 1500ml and then the anesthesiologist will infuse Saline 250 ml instead. The maintenance of basal fluid, criteria to use inotropes (If cardiac index is below 2.5 l/min/m2 ) are the same standards in the both groups.

Outcomes

Primary Outcome Measures

serum S100B protein
serum NGAL level

Secondary Outcome Measures

Length of hospital stay
Postoperative complications rate
Total intraoperative intravenous fluid administrated

Full Information

First Posted
April 8, 2014
Last Updated
December 2, 2014
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02113358
Brief Title
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supratentorial Neoplasms, Brain Tumor, Primary, Craniotomy
Keywords
fluid therapy, neurosurgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normovolemic group (keeping SVV<10% in supine; <15% in prone)
Arm Type
Experimental
Arm Description
The anesthesiologist will infuse Voluven (Fresenius Kabi, Bad Homburg, Germany) 250 ml if stroke volume variation is over 10% during the surgery to keep the normovolemia. If total Voluven use is over 1500ml and then the anesthesiologist will infuse Saline 250 ml instead. The maintenance of basal fluid, criteria to use inotropes (If cardiac index is below 2.5 l/min/m2 ) are the same standards in the both groups.
Arm Title
Restricitve group (keeping SVV < 18% in supine; <23% in prone)
Arm Type
Active Comparator
Arm Description
The anesthesiologist will infuse Voluven (Fresenius Kabi, Bad Homburg, Germany) 250 ml if stroke volume variation is over 18% during the surgery to keep the normovolemia. If total Voluven use is over 1500ml and then the anesthesiologist will infuse Saline 250 ml instead. The maintenance of basal fluid, criteria to use inotropes (If cardiac index is below 2.5 l/min/m2 ) are the same standards in the both groups.
Intervention Type
Drug
Intervention Name(s)
Intravenous colloid bolus with Voluven
Primary Outcome Measure Information:
Title
serum S100B protein
Time Frame
Changes from preoperative to postoperative day 2
Title
serum NGAL level
Time Frame
Changes from preoperative to postoperative day 2.
Secondary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks
Title
Postoperative complications rate
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks
Title
Total intraoperative intravenous fluid administrated
Time Frame
During the surgical time, an expected average of 3 to 5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chia-Chen Liu
Phone
+886-2-23123456
Ext
65521
Email
a0918994038@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Yu Wu, MD
Organizational Affiliation
National Taiwan University Hospital Anesthesiology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu Chun-Yu
Phone
+886-972653376
Email
longersolo@gmail.com
First Name & Middle Initial & Last Name & Degree
Chun-Yu Wu, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
28981592
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.
Results Reference
derived

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

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