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

NCT ID: NCT01738880

Last Updated: 2015-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-07-31

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.

Conditions

Brain Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

group C

intraoperative fluid management based on CVP

Group Type: ACTIVE_COMPARATOR

CVP

Intervention Type: DRUG

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.

group S

intraoperative fluid management based on SVV

Group Type: EXPERIMENTAL

SVV

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Severance hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

4-2012-0404

Identifier Type: -

Identifier Source: org_study_id