Benign NeoplasmsNCT03429127
Normal Saline Vrs Balanced i.v. Fluids in Neurosurgery
An observational study of Benign Neoplasms and Vascular Malformations, Brain, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
Trial summary
The purpose of this study was to investigate whether the balanced fluids therapy change plasma osmolality in neurosurgical procedures due to brain tumors, meningeomas and arterio-venous malformation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Neoplasms, Vascular Malformations, Brain
- What is being tested?
- Normal saline and Balanced fluid
- How many people
- 120 participants
- Where
- 1 siteCroatia
- Study dates
- 23 Mar 2017to 23 Feb 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent neurosurgical procedure because of brain tumor, meningeoma and vascular malformation. And without signs of elevated intracranial pressure and any history of kidney or heart disease.
Who may be able to join
- Patients with brain tumor, meningeomas and vascular malformation.
Who cannot join
- Patients with signs of elevated intracranial pressure; History of kidney disease, History of heart disease
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
UHC Zgagreb
Zagreb, 10000
Natasa Kovac, M.D., +38598296686, natasakovac787@gmail.com
Inga Mladic Batinica, M.D., +385917811015, ingamblue@gmail.com
About this study
Official title: Comparison of Normal Saline and Balanced Crystalloid Intravenous Therapy During Neurosurgery
The purpose of this study was to investigate whether the balanced fluids therapy change plasma osmolality in neurosurgical procedures due to brain tumors, meningeomas and arterio-venous malformation.
Read the detailed description
Normal saline or 0.9% sodium chloride solution is the most commonly used intravenous fluid worldwide and its composition are 154 mmol Na+ and 154 mmol Cl- per litter with osmolality of 308 mOsmol/L. That composition is not "normal" because plasma contains potassium in range between 137-146 mmol/L, and chloride in range between 98-106 mmol/L, with plasma osmolality of 280-295 mOsmol/kg. Recently published data suggested detrimental effects of chloride rich fluids on renal blood flow and glomerular filtration rate, urine output and acute kidney injury. One alternative to saline solution is a buffered, balanced, crystalloid solution with an electrolyte composition similar to plasma and osmolality between 286-295 mOsmol/L. Someone could indicate that such balanced solutions are not suitable for neurosurgical patients because of a possible impact on the brain edema development.
- Conditions
- Benign Neoplasms, Vascular Malformations, Brain
- Being tested
- Normal saline, Balanced fluid
- Keywords
- balanced fluids, neurosurgery, plasma osmolality
- Medical subject headings
- Neoplasms, Central Nervous System Vascular Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineOther
Also called 0,9 % sodium chloride
Plasma osmolality, acid base status and electrolytes after application up to 2000 ml of normal saline during neurosurgical operation
Balanced fluidOther
Also called Plasma-Lyte 148
Plasma osmolality, acid base status and electrolytes after application of up to 2000 ml balanced fluids during neurosurgical operation
| Study group | Role | What they receive |
|---|---|---|
| Normal saline fluid group | The patients in this group will receive up to 2000 ml of normal saline during neurosurgical operation. Receives: Other: Normal saline | |
| Balanced fluid group | The patients in this group will receive up to 2000 ml of balanced fluids during neurosurgical operation. Receives: Other: Balanced fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in acid base pH status
Changes in acid base pH status after each 500 ml of normal saline vrs. balanced fluid
Measured: During operation and immediately after operation
Secondary outcomes (1)
Changes in electrolytes (sodium and chloride)
Electrolytes changes (sodium and chloride) after each 500 ml of normal saline vrs. balanced fluid
Measured: During operation and immediately after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start23 Mar 2017
- Primary completion23 Oct 2019 (estimated)
- Study completion23 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Centre Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- Sisters of Mercy University Hospital
- Responsible party
- Principal investigator, Natasa Kovac, Clinical Hospital Centre Zagreb
- Investigators
- Natasa Kovac, M.D., Principal investigator, UHC Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429127
- Sponsor's protocol ID
- 02/21 AG
- Status last verified
- Apr 2019
- First submitted
- 3 Feb 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Normal Saline and Balanced Crystalloid Intravenous Therapy During Neurosurgery
- ClinicalTrials.gov ID
- NCT03429127
- Acronym / sponsor ID
- 02/21 AG
- Conditions
- Benign Neoplasms, Vascular Malformations, Brain
- Keywords
- balanced fluids, neurosurgery, plasma osmolality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Clinical Hospital Centre ZagrebUniversity, hospital or other
- Collaborators
- Sisters of Mercy University Hospital
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 23 Oct 2019 (estimated)
- Study completion
- 23 Feb 2020 (estimated)
- First posted
- 12 Feb 2018 (actual)
- 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.
The purpose of this study was to investigate whether the balanced fluids therapy change plasma osmolality in neurosurgical procedures due to brain tumors, meningeomas and arterio-venous malformation.
Detailed description
Normal saline or 0.9% sodium chloride solution is the most commonly used intravenous fluid worldwide and its composition are 154 mmol Na+ and 154 mmol Cl- per litter with osmolality of 308 mOsmol/L. That composition is not "normal" because plasma contains potassium in range between 137-146 mmol/L, and chloride in range between 98-106 mmol/L, with plasma osmolality of 280-295 mOsmol/kg. Recently published data suggested detrimental effects of chloride rich fluids on renal blood flow and glomerular filtration rate, urine output and acute kidney injury. One alternative to saline solution is a buffered, balanced, crystalloid solution with an electrolyte composition similar to plasma and osmolality between 286-295 mOsmol/L. Someone could indicate that such balanced solutions are not suitable for neurosurgical patients because of a possible impact on the brain edema development.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal saline fluid group | – | Other: Normal salineThe patients in this group will receive up to 2000 ml of normal saline during neurosurgical operation. |
| Balanced fluid group | – | Other: Balanced fluidThe patients in this group will receive up to 2000 ml of balanced fluids during neurosurgical operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent neurosurgical procedure because of brain tumor, meningeoma and vascular malformation. And without signs of elevated intracranial pressure and any history of kidney or heart disease.
Key inclusion criteria (1 listed)
- Patients with brain tumor, meningeomas and vascular malformation.
Key exclusion criteria (1 listed)
- Patients with signs of elevated intracranial pressure; History of kidney disease, History of heart disease
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 |
|---|---|---|
| Normal salineAlso: 0,9 % sodium chloridePlasma osmolality, acid base status and electrolytes after application up to 2000 ml of normal saline during neurosurgical operation | Other | Normal saline fluid group |
| Balanced fluidAlso: Plasma-Lyte 148Plasma osmolality, acid base status and electrolytes after application of up to 2000 ml balanced fluids during neurosurgical operation | Other | Balanced fluid group |
Primary outcome
Changes in acid base pH status
Time frame: During operation and immediately after operation
Changes in acid base pH status after each 500 ml of normal saline vrs. balanced fluid
1 secondary outcome
Changes in electrolytes (sodium and chloride)
Time frame: During operation and immediately after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Natasa Kovac, M.D. principal investigator
UHC Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Neoplasms and Vascular Malformations, Brain, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
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 1 inclusion and 1 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 18 Apr 2019. 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 Croatia. 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 Natasa Kovac, M.D. (+38598296686, natasakovac787@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in acid base pH status (time frame: During operation and immediately after operation). 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 18 Apr 2019; AzTrials last refreshed its copy on 31 Oct 2026.