Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT05023434 - A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
Completed NCT04474678 - Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!") N/A
Completed NCT02768389 - Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma Early Phase 1
Terminated NCT01902771 - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors Phase 1
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Recruiting NCT03286335 - Local Control, Quality of Life and Toxicities in Adults With Benign or Indolent Brain Tumors Undergoing Proton Radiation Therapy N/A
Recruiting NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Recruiting NCT05358340 - Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions N/A
Recruiting NCT03276676 - [18F]Fluciclovine and [18F]FLT PET/CT Assessment of Primary High-Grade Brain Tumors Phase 2
Completed NCT02851355 - Follow-up Survey of Patients Who Were Treated for Medulloblastoma or Primitive Neuroectodermal Tumors of the Central Nervous in Norway
Completed NCT02558569 - The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block Phase 4
Completed NCT02713087 - Vasopressor Effects in Anesthetized Patients Phase 4
Completed NCT02409121 - A Novel Health Information Technology System (BMT Roadmap) for Pediatric BMT Patients and Caregivers N/A
Withdrawn NCT02165995 - Use of Navigated Transcranial Magnetic Stimulation (nTMS) in Generated Motor and Language Mapping to Evaluate Brain Recovery Following Surgery N/A
Terminated NCT02674945 - Understanding and Improving Quality of Life Through a Wireless Activity Tracker: Observational Phase
Completed NCT01171469 - Vaccination With Dendritic Cells Loaded With Brain Tumor Stem Cells for Progressive Malignant Brain Tumor Phase 1
Withdrawn NCT01202539 - Real-time Assessment of Frameless Intrafraction Motion
Terminated NCT01044966 - A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma Phase 1/Phase 2
Completed NCT00760409 - Differentiating Recurrent Brain Tumor Versus Radiation Injury Using MRI N/A
Completed NCT00503204 - Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour Phase 1