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Effect of Goal-directed Fluid Therapy Based on Stroke Volume Variation on Metabolic Acidosis in Patients Undergoing Brain Tumor Surgery

Primary Purpose

Brain Tumor

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SVV
CVP
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Tumor

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing craniotomy due to brain tumor
  • American Society of Anesthesiologists physical status I or II
  • aged from 20 to 65

Exclusion Criteria:

  • compromised cardiopulmonary function
  • diabetes mellitus
  • symptom or sign with increased intracranial pressure
  • liver or renal disease
  • pre-existing metabolic acidosis
  • pregnant or breast-feeding
  • patients who cannot understand the statements for subjects

Sites / Locations

  • Severance hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

group C

group S

Arm Description

intraoperative fluid management based on CVP

intraoperative fluid management based on SVV

Outcomes

Primary Outcome Measures

Standard base excess point

Secondary Outcome Measures

Full Information

First Posted
November 18, 2012
Last Updated
January 26, 2015
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01738880
Brief Title
Effect of Goal-directed Fluid Therapy Based on Stroke Volume Variation on Metabolic Acidosis in Patients Undergoing Brain Tumor Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In patients undergoing craniotomy, 0.9% normal saline is commonly administered in order to reduce cerebral edema. Excessive administration of 0.9% normal saline has been to reported to cause hyperchloremic metabolic acidosis. On the other hand, hypovolemia due to insufficient fluid replacement for perioperative loss can also result in metabolic acidosis by lactic acid accumulation. However, the guideline for perioperative fluid management has not been yet established. The investigators hypothesized that intraoperative fluid management according to SVV(Stroke Volume Variation)could reduce perioperative metabolic acidosis compared to those by CVP(Central Venous Pressure). Therefore, the study is trying to determine if intraoperative fluid administration based on SVV could reduce metabolic acidosis when compared with CVP in patients undergoing craniotomy due to brain tumor who receive 0.9% normal saline as main fluid regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group C
Arm Type
Active Comparator
Arm Description
intraoperative fluid management based on CVP
Arm Title
group S
Arm Type
Experimental
Arm Description
intraoperative fluid management based on SVV
Intervention Type
Drug
Intervention Name(s)
SVV
Intervention Description
During the surgery, patients in group S receive additional fluids (400 ml of normal saline or 200 ml of colloid) when SVV is less than 13.
Intervention Type
Drug
Intervention Name(s)
CVP
Intervention Description
Patients in group C receive additional fluids (400 ml of normal saline or 200 ml of colloid) when CVP is less 8 during the surgery.
Primary Outcome Measure Information:
Title
Standard base excess point
Time Frame
at the suturing of scalp

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients undergoing craniotomy due to brain tumor American Society of Anesthesiologists physical status I or II aged from 20 to 65 Exclusion Criteria: compromised cardiopulmonary function diabetes mellitus symptom or sign with increased intracranial pressure liver or renal disease pre-existing metabolic acidosis pregnant or breast-feeding patients who cannot understand the statements for subjects
Facility Information:
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of Goal-directed Fluid Therapy Based on Stroke Volume Variation on Metabolic Acidosis in Patients Undergoing Brain Tumor Surgery

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