Intracranial NeoplasmNCT05145049
The Relationship of Anesthesia Method With Serum Lactate Level in Craniotomies
An observational study of Intracranial Neoplasm and Hyperlactatemia, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to research the incidence of hyperlactatemia in craniotomy cases, the relationship of lactate elevation with tumor type and other factors that may be related, and whether the general anesthesia method applied (inhalation anesthesia or total ıntravenous anesthesia) affects lactate level. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intracranial Neoplasm, Hyperlactatemia, Brain Tumor
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 30 Nov 2022
- How long will I take part?
- 3 Months
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients who scheduled to undergo elective craniotomy for an intracranial mass older than 18 years old
Who may be able to join
- Scheduled to undergo elective craniotomy for an intracranial mass
- adult patients
Who cannot join
- emergency
- In situations that may cause hyperlactatemia (such as sepsis, hepatic or renal failure, shock state, or patients who need inotropic support)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Training and Research Hospital
Ankara, 06110
About this study
The investigators aimed to research the incidence of hyperlactatemia in craniotomy cases, the relationship of lactate elevation with tumor type and other factors that may be related, and whether the general anesthesia method applied (inhalation anesthesia or total ıntravenous anesthesia) affects lactate level.
Read the detailed description
Lactate level is one of the easy-to-measure parameters that are frequently used in anesthesia and intensive care clinical practice, especially to evaluate the severity of disease and the response to treatment. In patients with high lactate levels, the first considerations are hypoperfusion and sepsis. However, many causes such as trauma, seizures, ischemia, diabetic ketoacidosis, thiamine deficiency, malignancies, liver dysfunction, genetic disorders, toxins, drugs, etc. can be associated with increased lactate. Many tissues in the body can produce lactate. 25% of production is from muscle, 25% skin, 20% brain, 20% RBC and 10% bowel cells. Some malignancies, especially hematological cancers, have also been associated with increased lactate. In recent years, it has been reported that serum lactate levels are associated with the degree of glial tumor malignancy, and that lactate can even be used as a non-invasive malignancy biomarker in brain tumors. In a recent study, it was reported that the type of 'glioblastoma multiforme' among patients who underwent craniotomy with the diagnosis of intracranial brain tumor was an independent influencer factor for preoperative and postoperative hyperlactatemia. Anesthesia is one of the factors that can affect lactate levels due to its effect on systemic perfusion and the hepatic effects of anesthetic drugs. It looks like that there is no study in the literature on the effect of anesthesia technique on hyperlactatemia in patients who underwent craniotomy. Therefore the investigators aimed to research the incidence of hyperlactatemia in craniotomy cases, the relationship of lactate elevation with tumor type and other factors that may be related, and whether the general anesthesia method applied (inhalation anesthesia or total ıntravenous anesthesia) affects lactate level.
- Conditions
- Intracranial Neoplasm, Hyperlactatemia, Brain Tumor, Hypoperfusion
- Keywords
- hyperlactatemia, craniotomy, total intravenous anesthesia, general anesthesia
- Medical subject headings
- Brain Neoplasms, Hyperlactatemia
What is being measured
The primary outcome is the main question the study is designed to answer.
lactate level
basal lactate level via arterial blood gas at the beginning of surgery
Measured: 0.hour
lactate level
lactate level via arterial blood gas at one hour after the beginning of surgery
Measured: 1.hour
lactate level
lactate level via arterial blood gas at three hour after the beginning of surgery
Measured: 3.hour
lactate level
lactate level via arterial blood gas at the end of the surgery
Measured: after extubation at the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Nov 2021
- Primary completion1 Sep 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intracranial NeoplasmStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ankara Diskapi Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Özkan Sipahioğlu, Ankara Diskapi Training and Research Hospital
- Investigators
- Fatma Özkan Sipahioglu, Principal investigator, Ankara Diskapi Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145049
- Sponsor's protocol ID
- Lactate
- Status last verified
- May 2024
- First submitted
- 8 Nov 2021
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Andersen LW, Mackenhauer J, Roberts JC, Berg KM, Cocchi MN, Donnino MW. Etiology and therapeutic approach to elevated lactate levels. Mayo Clin Proc. 2013 Oct;88(10):1127-40. doi: 10.1016/j.mayocp.2013.06.012.
PubMed 24079682Branco M, Linhares P, Carvalho B, Santos P, Costa BM, Vaz R. Serum lactate levels are associated with glioma malignancy grade. Clin Neurol Neurosurg. 2019 Nov;186:105546. doi: 10.1016/j.clineuro.2019.105546. Epub 2019 Oct 1.
PubMed 31605893Bharadwaj S, Venkatraghavan L, Mariappan R, Ebinu J, Meng Y, Khan O, Tung T, Reyhani S, Bernstein M, Zadeh G. Serum lactate as a potential biomarker of non-glial brain tumors. J Clin Neurosci. 2015 Oct;22(10):1625-7. doi: 10.1016/j.jocn.2015.05.009. Epub 2015 Jun 19.
PubMed 26100160Mariappan R, Venkatraghavan L, Vertanian A, Agnihotri S, Cynthia S, Reyhani S, Tung T, Khan OH, Zadeh G. Serum lactate as a potential biomarker of malignancy in primary adult brain tumours. J Clin Neurosci. 2015 Jan;22(1):144-8. doi: 10.1016/j.jocn.2014.06.005. Epub 2014 Aug 27.
PubMed 25172017Ioannoni E, Grande G, Olivi A, Antonelli M, Caricato A, Montano N. Factors affecting serum lactate in patients with intracranial tumors - A report of our series and review of the literature. Surg Neurol Int. 2020 Mar 6;11:39. doi: 10.25259/SNI_552_2019. eCollection 2020.
PubMed 32257565
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Anesthesia Method With Serum Lactate Level in Craniotomies
- ClinicalTrials.gov ID
- NCT05145049
- Acronym / sponsor ID
- Lactate
- Conditions
- Intracranial Neoplasm, Hyperlactatemia, Brain Tumor, Hypoperfusion
- Keywords
- hyperlactatemia, craniotomy, total intravenous anesthesia, general anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ankara Diskapi Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 6 Dec 2021 (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 investigators aimed to research the incidence of hyperlactatemia in craniotomy cases, the relationship of lactate elevation with tumor type and other factors that may be related, and whether the general anesthesia method applied (inhalation anesthesia or total ıntravenous anesthesia) affects lactate level.
Detailed description
Lactate level is one of the easy-to-measure parameters that are frequently used in anesthesia and intensive care clinical practice, especially to evaluate the severity of disease and the response to treatment. In patients with high lactate levels, the first considerations are hypoperfusion and sepsis. However, many causes such as trauma, seizures, ischemia, diabetic ketoacidosis, thiamine deficiency, malignancies, liver dysfunction, genetic disorders, toxins, drugs, etc. can be associated with increased lactate. Many tissues in the body can produce lactate. 25% of production is from muscle, 25% skin, 20% brain, 20% RBC and 10% bowel cells. Some malignancies, especially hematological cancers, have also been associated with increased lactate. In recent years, it has been reported that serum lactate levels are associated with the degree of glial tumor malignancy, and that lactate can even be used as a non-invasive malignancy biomarker in brain tumors. In a recent study, it was reported that the type of 'glioblastoma multiforme' among patients who underwent craniotomy with the diagnosis of intracranial brain tumor was an independent influencer factor for preoperative and postoperative hyperlactatemia. Anesthesia is one of the factors that can affect lactate levels due to its effect on systemic perfusion and the hepatic effects of anesthetic drugs. It looks like that there is no study in the literature on the effect of anesthesia technique on hyperlactatemia in patients who underwent craniotomy. Therefore the investigators aimed to research the incidence of hyperlactatemia in craniotomy cases, the relationship of lactate elevation with tumor type and other factors that may be related, and whether the general anesthesia method applied (inhalation anesthesia or total ıntravenous anesthesia) affects lactate level.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who scheduled to undergo elective craniotomy for an intracranial mass older than 18 years old
Key inclusion criteria (2 listed)
- Scheduled to undergo elective craniotomy for an intracranial mass
- adult patients
Key exclusion criteria (2 listed)
- emergency
- In situations that may cause hyperlactatemia (such as sepsis, hepatic or renal failure, shock state, or patients who need inotropic support)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
lactate level
Time frame: 0.hour
basal lactate level via arterial blood gas at the beginning of surgery
lactate level
Time frame: 1.hour
lactate level via arterial blood gas at one hour after the beginning of surgery
lactate level
Time frame: 3.hour
lactate level via arterial blood gas at three hour after the beginning of surgery
lactate level
Time frame: after extubation at the end of surgery
lactate level via arterial blood gas at 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 16 May 2024.
- Results publication: PubMed 24079682Andersen LW, Mackenhauer J, Roberts JC, Berg KM, Cocchi MN, Donnino MW. Etiology and therapeutic approach to elevated lactate levels. Mayo Clin Proc. 2013 Oct;88(10):1127-40. doi: 10.1016/j.mayocp.2013.06.012.
- Results publication: PubMed 31605893Branco M, Linhares P, Carvalho B, Santos P, Costa BM, Vaz R. Serum lactate levels are associated with glioma malignancy grade. Clin Neurol Neurosurg. 2019 Nov;186:105546. doi: 10.1016/j.clineuro.2019.105546. Epub 2019 Oct 1.
- Results publication: PubMed 26100160Bharadwaj S, Venkatraghavan L, Mariappan R, Ebinu J, Meng Y, Khan O, Tung T, Reyhani S, Bernstein M, Zadeh G. Serum lactate as a potential biomarker of non-glial brain tumors. J Clin Neurosci. 2015 Oct;22(10):1625-7. doi: 10.1016/j.jocn.2015.05.009. Epub 2015 Jun 19.
- Results publication: PubMed 25172017Mariappan R, Venkatraghavan L, Vertanian A, Agnihotri S, Cynthia S, Reyhani S, Tung T, Khan OH, Zadeh G. Serum lactate as a potential biomarker of malignancy in primary adult brain tumours. J Clin Neurosci. 2015 Jan;22(1):144-8. doi: 10.1016/j.jocn.2014.06.005. Epub 2014 Aug 27.
- Results publication: PubMed 32257565Ioannoni E, Grande G, Olivi A, Antonelli M, Caricato A, Montano N. Factors affecting serum lactate in patients with intracranial tumors - A report of our series and review of the literature. Surg Neurol Int. 2020 Mar 6;11:39. doi: 10.25259/SNI_552_2019. eCollection 2020.
Related trials for Intracranial Neoplasm
RecruitingPhase 2
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
Intracranial Meningioma, Recurrent Meningioma
RecruitingPhase 1
Dose Ranging, Toxicity Seeking, Phase 1 Trial of Oncolytic Adenoviral Therapy for Melanoma Intracranial and Extracranial Metastases
Melanoma
Active, not recruitingPhase 1/2
RNA Lipid Particles Targeting Pediatric Recurrent Intracranial Malignancies and Other systEmic Solid Tumors
Recurrent Pulmonary Osteosarcoma, Recurrent High-grade Glioma
Not yet recruitingObservational study
Impact of a Radiologic and Immunologic Signature on Cerebral Efficacy of Treatments in Lung Cancers With Brain Metastasis
Carcinoma, Non-Small-Cell Lung
RecruitingPhase 2
A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma
Meningioma
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.
Fatma Özkan Sipahioglu principal investigator
Ankara Diskapi Research and Training Hospital
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 Intracranial Neoplasm and Hyperlactatemia, run by Ankara Diskapi Training and Research Hospital 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 2 inclusion and 2 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 16 May 2024. 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: 0.hour). The study lists 4 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 NCT05145049, which also lists 5 linked publications.
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 16 May 2024.