Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During Craniotomy: a Randomized Controlled Trial

Fluid management during neurosurgery presents a special clinical agenda. Volume overload can have detrimental effects on intracranial pressure by increasing either cerebral blood volume or hydrostatically driven cerebral edema formation. On the other hand, an overt restrictive fluid strategy may risk hemodynamic instability.

Recently, dynamic fluid responsiveness parameters such as stroke volume variation (SVV) have been shown as a more precise parameters for fluid management including in neurosurgical patients. The threshold of SVV is reported about 10-15%. In this study, the investigators aim to using two SVV threshold to conduct intraoperative fluid therapy for craniotomy. Randomization will be generated by computer sampling. One of the two groups of patients will be managed with fluid bolus to keep intraoperative SVV <10% presenting the "normovolemia" group. The other group of patients will be kept intraoperative SVV <18% which is slightly above previously reported SVV threshold upper limit. The second group thus presents the "restrictive" group. Clinical outcomes, laboratory analysis including S100-B for neuronal damage and neutrophil gelatinase-associated lipocalin (NGAL) for acute kidney injury, will be compared.

Study Overview

• Status: Unknown
• Conditions: Supratentorial Neoplasms; Craniotomy; Brain Tumor, Primary
• Intervention / Treatment: Drug: Intravenous colloid bolus with Voluven

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Wu Chun-Yu; Phone Number: +886-972653376; Email: longersolo@gmail.com
    • Principal Investigator: Chun-Yu Wu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Supratentorial brain tumor receiving elective craniotomy
• BMI between 18.5-27.0 kg.m-2

Exclusion Criteria:

• Cardiac dysfunction, such as coronary artery diseases; atrial fibrillation;

  • NYHA class II
• Renal dysfunction, eGFR< 60 ml.min-1.1.73m-2
• Pulmonary cormorbidity, such as COPD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normovolemic group (keeping SVV<10% in supine; <15% in prone); The anesthesiologist will infuse Voluven (Fresenius Kabi, Bad Homburg, Germany) 250 ml if stroke volume variation is over 10% during the surgery to keep the normovolemia.; If total Voluven use is over 1500ml and then the anesthesiologist will infuse Saline 250 ml instead.; The maintenance of basal fluid, criteria to use inotropes (If cardiac index is below 2.5 l/min/m2 ) are the same standards in the both groups.	Drug: Intravenous colloid bolus with Voluven
Active Comparator: Restricitve group (keeping SVV < 18% in supine; <23% in prone); The anesthesiologist will infuse Voluven (Fresenius Kabi, Bad Homburg, Germany) 250 ml if stroke volume variation is over 18% during the surgery to keep the normovolemia.; If total Voluven use is over 1500ml and then the anesthesiologist will infuse Saline 250 ml instead.; The maintenance of basal fluid, criteria to use inotropes (If cardiac index is below 2.5 l/min/m2 ) are the same standards in the both groups.	Drug: Intravenous colloid bolus with Voluven

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
serum S100B protein	Changes from preoperative to postoperative day 2
serum NGAL level	Changes from preoperative to postoperative day 2.

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay	participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks
Postoperative complications rate	participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks
Total intraoperative intravenous fluid administrated	During the surgical time, an expected average of 3 to 5 hours

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chun-Yu Wu, MD, National Taiwan University Hospital Anesthesiology Department

Publications and helpful links

General Publications

• Wu CY, Lin YS, Tseng HM, Cheng HL, Lee TS, Lin PL, Chou WH, Cheng YJ. Comparison of two stroke volume variation-based goal-directed fluid therapies for supratentorial brain tumour resection: a randomized controlled trial. Br J Anaesth. 2017 Nov 1;119(5):934-942. doi: 10.1093/bja/aex189.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): May 1, 2015

Study Registration Dates

• First Submitted: April 8, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (Estimate): April 14, 2014

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: neurosurgery; fluid therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms; Supratentorial Neoplasms
• Other Study ID Numbers: 201312116RINC