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

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ClinicalTrials.gov Identifier: NCT02113358
Recruitment Status : Unknown
Verified December 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : April 14, 2014
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.


Condition or disease Intervention/treatment Phase
Supratentorial Neoplasms Brain Tumor, Primary Craniotomy Drug: Intravenous colloid bolus with Voluven Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During Craniotomy: a Randomized Controlled Trial
Study Start Date : April 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Hextend

Arm Intervention/treatment
Experimental: 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.
Drug: Intravenous colloid bolus with Voluven
Active Comparator: 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.
Drug: Intravenous colloid bolus with Voluven



Primary Outcome Measures :
  1. serum S100B protein [ Time Frame: Changes from preoperative to postoperative day 2 ]
  2. serum NGAL level [ Time Frame: Changes from preoperative to postoperative day 2. ]

Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks ]
  2. Postoperative complications rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks ]
  3. Total intraoperative intravenous fluid administrated [ Time Frame: During the surgical time, an expected average of 3 to 5 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113358


Contacts
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Contact: Chia-Chen Liu +886-2-23123456 ext 65521 a0918994038@yahoo.com.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Wu Chun-Yu    +886-972653376    longersolo@gmail.com   
Principal Investigator: Chun-Yu Wu, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Chun-Yu Wu, MD National Taiwan University Hospital Anesthesiology Department

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02113358    
Other Study ID Numbers: 201312116RINC
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014
Keywords provided by National Taiwan University Hospital:
fluid therapy
neurosurgery
Additional relevant MeSH terms:
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Brain Neoplasms
Supratentorial Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes