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

Brain Tumor Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01738880
• Other study ID #: 4-2012-0404
• Status: Completed
• Phase: N/A
• First received: November 18, 2012
• Last updated: January 26, 2015
• Start date: December 2012
• Est. completion date: July 2014

Study information

• Verified date: January 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard base excess point		at the suturing of scalp	No