Brain NeoplasmsPhase 2NCT02707549
Fluid Therapy During Brain Tumor Resection in Children
A Phase 2 study testing balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride) and 0.9% sodium chloride in people with Brain Neoplasms, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Fluid management of children during neurosurgery is not well established. Hypotonic solutions, commonly still used in pediatric patients, may enhance cerebral edema and worse operative conditions. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride) and 0.9% sodium chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2015to Jun 2017
- Phase
- Phase 2
- 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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children undergoing elective craniotomy for brain tumor resection
- Informed consent form signed and dated by legal guardian and investigator
- Informed assent form signed by the patient if appropriate
Who cannot join
- Uncontrolled Intracranial hypertension
- Severe heart, kidney, or pulmonary disease
- non-corrected electrolyte imbalance
- allergy to the solution administered
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Balanced Crystalloid Solution and 0,9% Sodium Chloride in Children Undergoing Brain Tumor Resection: a Randomized Controlled Trial
Fluid management of children during neurosurgery is not well established. Hypotonic solutions, commonly still used in pediatric patients, may enhance cerebral edema and worse operative conditions. This study compares two different isotonic solutions administered perioperatively regarding acid base and fluid electrolyte disturbances.
- Conditions
- Brain Neoplasms
- Being tested
- balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride), 0.9% sodium chloride
- Keywords
- crystalloid solutions, acid-base imbalance, water-electrolyte Imbalance
- Medical subject headings
- Brain Neoplasms, Acid-Base Imbalance, Water-Electrolyte Imbalance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride)Drug
0.9% sodium chlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline Group | Active comparator | the patients included in this group will receive normal saline solution (0.9% sodium chloride) during surgery and in the first 24 hours after ICU admission. Receives: Drug: 0.9% sodium chloride |
| Balanced Crystalloid Solution Group | Experimental | the patients included in this group will receive balanced crystalloid solution during surgery and in the first 24 hours after ICU admission. Receives: Drug: balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride) |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum chloride difference (mmol/L)
Serum chloride will be collected in two different moments: right before the beginning of the surgery and right after de end of the procedure. We will calculate the difference between the two values.
Measured: from the admission of the patient in the operating room until the end of the surgery.
Secondary outcomes (3)
serum chloride difference (mmol/L)
Serum chloride will be collected right after the end of the surgery as well as 24 hours after the admission in ICU. We will calculate the difference between the two values.
Measured: from the end of the surgery until exactly 24 hours after the admission in intensive care unit (ICU)
brain relaxation score
Measured: immediately after dura-mater opening
serum sodium difference (mmol/L)
Serum sodium will be collected in two different moments: right before the beginning of the surgery and right after de end of the procedure. We will calculate the difference between the two values.
Measured: from the admission of the patient in the operating room until the end of the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Fontes Lima Neville, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707549
- Sponsor's protocol ID
- CAAE: 44552315.1.0000.5505
- Status last verified
- Nov 2017
- First submitted
- 6 Mar 2016
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Balanced Crystalloid Solution and 0,9% Sodium Chloride in Children Undergoing Brain Tumor Resection: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02707549
- Acronym / sponsor ID
- CAAE: 44552315.1.0000.5505
- Conditions
- Brain Neoplasms
- Keywords
- crystalloid solutions, acid-base imbalance, water-electrolyte Imbalance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 14 Mar 2016 (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 of children during neurosurgery is not well established. Hypotonic solutions, commonly still used in pediatric patients, may enhance cerebral edema and worse operative conditions. This study compares two different isotonic solutions administered perioperatively regarding acid base and fluid electrolyte disturbances.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline Group | Active comparator | Drug: 0.9% sodium chloridethe patients included in this group will receive normal saline solution (0.9% sodium chloride) during surgery and in the first 24 hours after ICU admission. |
| Balanced Crystalloid Solution Group | Experimental | Drug: balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride)the patients included in this group will receive balanced crystalloid solution during surgery and in the first 24 hours after ICU admission. |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children undergoing elective craniotomy for brain tumor resection
- Informed consent form signed and dated by legal guardian and investigator
- Informed assent form signed by the patient if appropriate
Key exclusion criteria (4 listed)
- Uncontrolled Intracranial hypertension
- Severe heart, kidney, or pulmonary disease
- non-corrected electrolyte imbalance
- allergy to the solution administered
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 |
|---|---|---|
| balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride) | Drug | Balanced Crystalloid Solution Group |
| 0.9% sodium chloride | Drug | Normal Saline Group |
Primary outcome
serum chloride difference (mmol/L)
Time frame: from the admission of the patient in the operating room until the end of the surgery.
Serum chloride will be collected in two different moments: right before the beginning of the surgery and right after de end of the procedure. We will calculate the difference between the two values.
3 secondary outcomes
serum chloride difference (mmol/L)
Time frame: from the end of the surgery until exactly 24 hours after the admission in intensive care unit (ICU)
brain relaxation score
Time frame: immediately after dura-mater opening
serum sodium difference (mmol/L)
Time frame: from the admission of the patient in the operating room until the end of the surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride) and 0.9% sodium chloride in people with Brain Neoplasms, run by Federal University of São Paulo at 1 site in Brazil.
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 3 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: finished, as of the sponsor's last update on 14 Nov 2017. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum chloride difference (mmol/L) (time frame: from the admission of the patient in the operating room until the end of the surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2017.