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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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ClinicalTrials.gov Identifier: NCT01738880
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : January 28, 2015
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Brain Tumor Drug: SVV Drug: CVP Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Study Start Date : December 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: group C
intraoperative fluid management based on CVP
Drug: CVP
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.
Experimental: group S
intraoperative fluid management based on SVV
Drug: SVV
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.



Primary Outcome Measures :
  1. Standard base excess point [ Time Frame: at the suturing of scalp ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738880


Locations
Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01738880     History of Changes
Other Study ID Numbers: 4-2012-0404
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases