Effect of Goal-directed Fluid Therapy Based on Stroke Volume Variation on Metabolic Acidosis in Patients Undergoing Brain Tumor Surgery
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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 |
- 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: | August 2013 |
| Estimated Primary Completion Date: | July 2013 (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 |
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| Contact: Seung Ho Choi, MD | 82-2-2227-3833 | csho99@yuhs.ac |
| Korea, Republic of | |
| Severance hospital | Not yet 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 | |
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: | November 27, 2012 |
| 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 May 23, 2013