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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05145049
Other study ID # Lactate
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date November 30, 2022

Study information

Verified date May 2024
Source Ankara Diskapi Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date November 30, 2022
Est. primary completion date September 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Scheduled to undergo elective craniotomy for an intracranial mass - adult patients Exclusion Criteria: - emergency - In situations that may cause hyperlactatemia (such as sepsis, hepatic or renal failure, shock state, or patients who need inotropic support)

Study Design


Locations

Country Name City State
Turkey Diskapi Training and Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara Diskapi Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

Bharadwaj 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 — View Citation

Branco 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. — View Citation

Ioannoni 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. e — View Citation

Mariappan 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.2014.0 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary lactate level basal lactate level via arterial blood gas at the beginning of surgery 0.hour
Primary lactate level lactate level via arterial blood gas at one hour after the beginning of surgery 1.hour
Primary lactate level lactate level via arterial blood gas at three hour after the beginning of surgery 3.hour
Primary lactate level lactate level via arterial blood gas at the end of the surgery after extubation at the end of surgery
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