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

NCT ID: NCT02113358

Last Updated: 2014-12-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-05-31

Brief Summary

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.

Conditions

Supratentorial Neoplasms; Brain Tumor, Primary; Craniotomy

Study Design

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

Study Groups

Normovolemic group (keeping SVV<10% in supine; <15% in prone)

1. 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.

2. If total Voluven use is over 1500ml and then the anesthesiologist will infuse Saline 250 ml instead.

3. 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.

Group Type: EXPERIMENTAL

Intravenous colloid bolus with Voluven

Intervention Type: DRUG

Restricitve group (keeping SVV < 18% in supine; <23% in prone)

1. 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.

2. If total Voluven use is over 1500ml and then the anesthesiologist will infuse Saline 250 ml instead.

3. 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.

Group Type: ACTIVE_COMPARATOR

Intravenous colloid bolus with Voluven

Intervention Type: DRUG

Interventions

Intravenous colloid bolus with Voluven

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chun-Yu Wu, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital Anesthesiology Department

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chia-Chen Liu

Role: CONTACT

a0918994038@yahoo.com.tw

+886-2-23123456 ext. 65521

Facility Contacts

Wu Chun-Yu

Role: primary

longersolo@gmail.com

+886-972653376

References

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.

Reference Type: DERIVED

PMID: 28981592 (View on PubMed)

Other Identifiers

201312116RINC

Identifier Type: -

Identifier Source: org_study_id