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

NCT02113358 | Unknown

• 1 other identifier: 201312116RINC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

fluid therapy; neurosurgery

Outcome Measures

Primary Outcomes (2)

• serum S100B protein

  Changes from preoperative to postoperative day 2

• serum NGAL level

  Changes from preoperative to postoperative day 2.

Secondary Outcomes (3)

• 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

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: Intravenous colloid bolus with Voluven

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

ACTIVE COMPARATOR

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.

Drug: Intravenous colloid bolus with Voluven

Interventions

Intravenous colloid bolus with Voluven DRUG

Normovolemic group (keeping SVV<10% in supine; <15% in prone); Restricitve group (keeping SVV < 18% in supine; <23% in prone)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 28981592 DERIVED

MeSH Terms

Conditions

Supratentorial Neoplasms; Brain Neoplasms

Interventions

HES 130-0.4

Condition Hierarchy (Ancestors)

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

Study Officials

• Chun-Yu Wu, MD

  National Taiwan University Hospital Anesthesiology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-Chen Liu

CONTACT

+886-2-23123456; a0918994038@yahoo.com.tw

Study Design

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

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 14, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

TW (1)