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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01738880
First received: November 18, 2012
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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 Intervention
Brain Tumor
Drug: SVV
Drug: CVP

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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Standard base excess point [ Time Frame: at the suturing of scalp ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738880

Contacts
Contact: Seung Ho Choi, MD 82-2-2227-3833 csho99@yuhs.ac

Locations
Korea, Republic of
Severance hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jae Hoon Lee, MD    82-2-2227-3972    neogens@yuhs.ac   
Sub-Investigator: Jae Hoon Lee, MD         
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01738880     History of Changes
Other Study ID Numbers: 4-2012-0404
Study First Received: November 18, 2012
Last Updated: February 17, 2014
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Brain Neoplasms
Acidosis
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Acid-Base Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014