Supratentorial NeoplasmsNCT02113358
Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During Craniotomy: a Randomized Controlled Trial
A study testing Intravenous colloid bolus with Voluven in people with Supratentorial Neoplasms and Brain Tumor, Primary, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Supratentorial Neoplasms, Brain Tumor, Primary, Craniotomy
- What is being tested?
- Intravenous colloid bolus with Voluven
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Supratentorial brain tumor receiving elective craniotomy
- BMI between 18.5-27.0 kg.m-2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Wu Chun-Yu, +886-972653376, longersolo@gmail.com
Chun-Yu Wu, MD
About this study
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
- Being tested
- Intravenous colloid bolus with Voluven
- Keywords
- fluid therapy, neurosurgery
- Medical subject headings
- Supratentorial Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous colloid bolus with VoluvenDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Intravenous colloid bolus with Voluven |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum S100B protein
Measured: Changes from preoperative to postoperative day 2
serum NGAL level
Measured: Changes from preoperative to postoperative day 2.
Secondary outcomes (3)
Length of hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks
Postoperative complications rate
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks
Total intraoperative intravenous fluid administrated
Measured: During the surgical time, an expected average of 3 to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supratentorial NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Yu Wu, MD, Principal investigator, National Taiwan University Hospital Anesthesiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113358
- Sponsor's protocol ID
- 201312116RINC
- Status last verified
- Dec 2014
- First submitted
- 8 Apr 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28981592
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Stroke Volume Variation-guided Normovolemic and Restrictive Fluid Management During Craniotomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02113358
- Acronym / sponsor ID
- 201312116RINC
- Conditions
- Supratentorial Neoplasms, Brain Tumor, Primary, Craniotomy
- Keywords
- fluid therapy, neurosurgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normovolemic group (keeping SVV<10% in supine; <15% in prone) | Experimental | Drug: Intravenous colloid bolus with Voluven1. 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. |
| Restricitve group (keeping SVV < 18% in supine; <23% in prone) | Active comparator | Drug: Intravenous colloid bolus with Voluven1. 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Supratentorial brain tumor receiving elective craniotomy
- BMI between 18.5-27.0 kg.m-2
Key exclusion criteria (4 listed)
- Cardiac dysfunction, such as coronary artery diseases; atrial fibrillation;
- Renal dysfunction, eGFR< 60 ml.min-1.1.73m-2
- Pulmonary cormorbidity, such as COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) |
Primary outcome
serum S100B protein
Time frame: Changes from preoperative to postoperative day 2
serum NGAL level
Time frame: Changes from preoperative to postoperative day 2.
3 secondary outcomes
Length of hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks
Postoperative complications rate
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 to 4 weeks
Total intraoperative intravenous fluid administrated
Time frame: During the surgical time, an expected average of 3 to 5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Derived from this study: PubMed 28981592Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Yu Wu, MD principal investigator
National Taiwan University Hospital Anesthesiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous colloid bolus with Voluven in people with Supratentorial Neoplasms and Brain Tumor, Primary, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chia-Chen Liu (+886-2-23123456 ext. 65521, a0918994038@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum S100B protein (time frame: Changes from preoperative to postoperative day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02113358, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.