LactateNCT04584827
Evaluation of Lactate in Patients Undergoing Glial and Non Glial Mass Surgery With Craniotomy
An observational study of Lactate and Brain Tumor, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effects of the level of metabolites used in routine on mortality and morbidity in patients who will undergo intracranial surgery with craniotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lactate, Brain Tumor, Post-Op Complication
- What is being tested?
- lactate level and Glasgow Outcome Scale
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2019to 10 Jul 2022
- 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: It is planned to include intracranial mass operations performed by craniotomy between 10 December 2019 - 10 December 2020 in Trakya University Faculty of Medicine, Department of Neurosurgery.
Who may be able to join
- Having an intracranial mass operation with craniotomy
- No history of congestive heart failure
- No kidney and liver dysfunction
- Not pregnant
- Not taking inotropic drugs during the operation
- Receiving less than four red blood product replacements during the operation
Who cannot join
- Patients with a history of congestive heart failure
- Patients with kidney and liver dysfunction
- Patients who need an inotropic agent to adjust blood pressure during the operation
- Patients who have undergone four or more red blood product transfusions during the operation
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine the effects of the level of metabolites used in routine on mortality and morbidity in patients who will undergo intracranial surgery with craniotomy.
Read the detailed description
In this study, in patients who are planned to have an intracranial mass operation with craniotomy, their medical histories, demographic features, comorbidities, preoperative radiotherapy treatment, the parameters examined in the preoperative routine will be collected as a file scan (previous operations, GKS, laboratory values). The classification of patients according to the 2016 World Health Organization Central Classification of Nervous System Tumors (WHO-CNS classification) and whether it is glial or non glial will be recorded from the clinical file. Intraoperative; hemodynamic data of patients; heart rate, diastolic, systolic and mean arterial pressures, fluid and blood products delivered, anesthetic and other medications, and blood gas samples will be written from the anesthesia document after the operation is finished. For the study, the application of the anesthesiologist for the patient will not be interfered. If postoperative patients are sent to the intensive care unit, their laboratory values and clinical observations (mortality, morbidity, neurological sequelae, imaging techniques, GOSE (Glasgow outcome skale)) will be recorded. In our study, mortality and morbidity will be evaluated 30 days postoperatively, and if the patient was sent to the service from the intensive care unit in this process, the values in the postoperative clinic (mortality, morbidity, neurological evaluation, imaging techniques, pathology results) will be recorded from the patient document. If the patient was discharged 30 days before, outpatient data will be recorded. The patients will be classified by evaluating the collected data (intraoperative hemodynamic data, blood transfusions, postoperative neurological sequel, postoperative complications and mortality).
In our study; the effects of lactate level on mortality and morbidity will be investigated in patients undergoing an intracranial mass operation with general anesthesia.
- Conditions
- Lactate, Brain Tumor, Post-Op Complication
- Being tested
- lactate level, Glasgow Outcome Scale
- Keywords
- lactate, glial and non glial tumor, intracranial, craniotomy
- Medical subject headings
- Brain Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lactate levelOther
Also called lac
Lactate, a byproduct of glycolysis, is an indicator of weak tissue perfusion and a useful biomarker with prognostic value in various diseases. Lactate value is calculated by blood gas.
Glasgow Outcome ScaleOther
Also called GOS
Glasgow Outcome Scale; It is a scale developed to categorize people suffering from head trauma or non-traumatic acute brain injury into broad outcome categories. It shows postoperative mortality and morbidity of patients who underwent intracranial surgery.
| Study group | Role | What they receive |
|---|---|---|
| complication positive (up to 30 days after surgery) | Complications:
* Moderate to severe intracerebral hemorrhage confirmed in a brain CT scan (Midline shift in brain imaging ≥ 3 mm),
* İntracranial hypertension requiring post op surgical drainage,
* Status epilepticus or seizures,
* The need for tracheal intubation or use of mechanical ventilation after surgery,
* Decrease in GKS,
* Unmanageable agitation that requires restriction or sedation,
* Need for respiratory failure and oxygen therapy,
* Unexpected serious motor deficit
* Died Receives: Other: lactate level; Other: Glasgow Outcome Scale | |
| complication negative (up to 30 days after surgery) | No complications are seen within 30 days and the patient is healthy Receives: Other: lactate level; Other: Glasgow Outcome Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
lactate level
Lactate, a byproduct of glycolysis, is an indicator of weak tissue perfusion and a useful biomarker with prognostic value in various diseases. Lactate value is calculated by blood gas.
Measured: change from operation to post-op second day (4 time)
Secondary outcomes (1)
Glasgow Outcome Scale
Glasgow Outcome Scale; It is a scale developed to categorize people suffering from head trauma or non-traumatic acute brain injury into broad outcome categories. It shows postoperative mortality and morbidity of patients who underwent intracranial surgery. Glasgow Outcome Scale is a five-point scale. 1 point is considered death and five points as good recovery. As the score increases, morbidity and mortality decrease.
Measured: 30 days after the operation (1 time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start10 Dec 2019
- Primary completion10 Dec 2021
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactateStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Kucuk, Trakya University
- Investigators
- SEVTAP HEKİMOĞLU ŞAHİN, Professor, Principal investigator, Trakya UniversityONUR KÜÇÜK, Resident, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584827
- Sponsor's protocol ID
- TÜTF-BAEK 2019/450
- Status last verified
- Jan 2023
- First submitted
- 6 Oct 2020
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lactate in Patients Undergoing Glial and Non Glial Mass Surgery With Craniotomy
- ClinicalTrials.gov ID
- NCT04584827
- Acronym / sponsor ID
- TÜTF-BAEK 2019/450
- Conditions
- Lactate, Brain Tumor, Post-Op Complication
- Keywords
- lactate, glial and non glial tumor, intracranial, craniotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 14 Oct 2020 (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 aim of this study is to determine the effects of the level of metabolites used in routine on mortality and morbidity in patients who will undergo intracranial surgery with craniotomy.
Detailed description
In this study, in patients who are planned to have an intracranial mass operation with craniotomy, their medical histories, demographic features, comorbidities, preoperative radiotherapy treatment, the parameters examined in the preoperative routine will be collected as a file scan (previous operations, GKS, laboratory values). The classification of patients according to the 2016 World Health Organization Central Classification of Nervous System Tumors (WHO-CNS classification) and whether it is glial or non glial will be recorded from the clinical file. Intraoperative; hemodynamic data of patients; heart rate, diastolic, systolic and mean arterial pressures, fluid and blood products delivered, anesthetic and other medications, and blood gas samples will be written from the anesthesia document after the operation is finished. For the study, the application of the anesthesiologist for the patient will not be interfered. If postoperative patients are sent to the intensive care unit, their laboratory values and clinical observations (mortality, morbidity, neurological sequelae, imaging techniques, GOSE (Glasgow outcome skale)) will be recorded. In our study, mortality and morbidity will be evaluated 30 days postoperatively, and if the patient was sent to the service from the intensive care unit in this process, the values in the postoperative clinic (mortality, morbidity, neurological evaluation, imaging techniques, pathology results) will be recorded from the patient document. If the patient was discharged 30 days before, outpatient data will be recorded. The patients will be classified by evaluating the collected data (intraoperative hemodynamic data, blood transfusions, postoperative neurological sequel, postoperative complications and mortality).
In our study; the effects of lactate level on mortality and morbidity will be investigated in patients undergoing an intracranial mass operation with general anesthesia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| complication positive (up to 30 days after surgery) | – | Other: lactate level, Other: Glasgow Outcome ScaleComplications: * Moderate to severe intracerebral hemorrhage confirmed in a brain CT scan (Midline shift in brain imaging ≥ 3 mm), * İntracranial hypertension requiring post op surgical drainage, * Status epilepticus or seizures, * The need for tracheal intubation or use of mechanical ventilation after surgery, * Decrease in GKS, * Unmanageable agitation that requires restriction or sedation, * Need for respiratory failure and oxygen therapy, * Unexpected serious motor deficit * Died |
| complication negative (up to 30 days after surgery) | – | Other: lactate level, Other: Glasgow Outcome ScaleNo complications are seen within 30 days and the patient is healthy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is planned to include intracranial mass operations performed by craniotomy between 10 December 2019 - 10 December 2020 in Trakya University Faculty of Medicine, Department of Neurosurgery.
Key inclusion criteria (6 listed)
- Having an intracranial mass operation with craniotomy
- No history of congestive heart failure
- No kidney and liver dysfunction
- Not pregnant
- Not taking inotropic drugs during the operation
Key exclusion criteria (5 listed)
- Patients with a history of congestive heart failure
- Patients with kidney and liver dysfunction
- Patients who need an inotropic agent to adjust blood pressure during the operation
- Patients who have undergone four or more red blood product transfusions during the operation
- Pregnant patients
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 |
|---|---|---|
| lactate levelAlso: lacLactate, a byproduct of glycolysis, is an indicator of weak tissue perfusion and a useful biomarker with prognostic value in various diseases. Lactate value is calculated by blood gas. | Other | complication negative (up to 30 days after surgery), complication positive (up to 30 days after surgery) |
| Glasgow Outcome ScaleAlso: GOSGlasgow Outcome Scale; It is a scale developed to categorize people suffering from head trauma or non-traumatic acute brain injury into broad outcome categories. It shows postoperative mortality and morbidity of patients who underwent intracranial surgery. | Other | complication negative (up to 30 days after surgery), complication positive (up to 30 days after surgery) |
Primary outcome
lactate level
Time frame: change from operation to post-op second day (4 time)
Lactate, a byproduct of glycolysis, is an indicator of weak tissue perfusion and a useful biomarker with prognostic value in various diseases. Lactate value is calculated by blood gas.
1 secondary outcome
Glasgow Outcome Scale
Time frame: 30 days after the operation (1 time)
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 19 Jan 2023.
- 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.
SEVTAP HEKİMOĞLU ŞAHİN, Professor principal investigator
Trakya University
ONUR KÜÇÜK, Resident principal investigator
Trakya University
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 Lactate and Brain Tumor, run by Trakya University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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 19 Jan 2023. 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 Turkey (Türkiye). 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?
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?
lactate level (time frame: change from operation to post-op second day (4 time)). 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 19 Jan 2023.