NCT05145049

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

November 8, 2021

Last Update Submit

May 14, 2024

Conditions

Intracranial NeoplasmHyperlactatemiaBrain TumorHypoperfusion

Keywords

hyperlactatemiacraniotomytotal intravenous anesthesiageneral anesthesia

Outcome Measures

Primary Outcomes (4)

  • lactate level

    basal lactate level via arterial blood gas at the beginning of surgery

    0.hour

  • lactate level

    lactate level via arterial blood gas at one hour after the beginning of surgery

    1.hour

  • lactate level

    lactate level via arterial blood gas at three hour after the beginning of surgery

    3.hour

  • lactate level

    lactate level via arterial blood gas at the end of the surgery

    after extubation at the end of surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who scheduled to undergo elective craniotomy for an intracranial mass older than 18 years old

You may qualify if:

  • Scheduled to undergo elective craniotomy for an intracranial mass
  • adult patients

You may not qualify if:

  • emergency
  • In situations that may cause hyperlactatemia (such as sepsis, hepatic or renal failure, shock state, or patients who need inotropic support)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

Related 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.

    PMID: 24079682RESULT

  • 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.

    PMID: 31605893RESULT

  • 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 2015 Jun 19.

    PMID: 26100160RESULT

  • 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.2014.06.005. Epub 2014 Aug 27.

    PMID: 25172017RESULT

  • 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. eCollection 2020.

    PMID: 32257565RESULT

MeSH Terms

Conditions

Brain NeoplasmsHyperlactatemia

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fatma Özkan Sipahioglu

    Ankara Diskapi Research and Training Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Anesthesiologist

Study Record Dates

First Submitted

November 8, 2021

First Posted

December 6, 2021

Study Start

November 1, 2021

Primary Completion

September 1, 2022

Study Completion

November 30, 2022

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations

TU(1)