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

NCT01738880 | Completed

• 1 other identifier: 4-2012-0404
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Standard base excess point

  at the suturing of scalp

Study Arms (2)

group C

ACTIVE COMPARATOR

intraoperative fluid management based on CVP

Drug: CVP

group S

EXPERIMENTAL

intraoperative fluid management based on SVV

Drug: SVV

Interventions

SVV 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.

group S

CVP 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 C

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2012
• First Posted: November 30, 2012
• Study Start: December 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 28, 2015

Record last verified: 2015-01

Locations

KR (1)