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CompletedNCT03531307Updated Feb 15, 2019

Lactate Levels Correlates With Ki-67 in Brain Tumor Surgery

An observational study in Brain Tumor and Anesthesia, sponsored by Ricard Valero. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Ricard Valero · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
100
Sex
All
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Study summary

In neurosurgery, brain tumor patients show increased levels of lactate at the beginning of surgery. This has been related to malignancy. Ki-67 is a cell proliferation index used as a marker of tumor mitotic activity.

This research aims to describe the correlation between lactate levels and the Ki-67 index in patients with brain tumor.

Read the detailed description

Lactate levels are used in the evaluation of perfusion status in critical care. Increases not related to a hypoperfusion state are observed in the patient with brain tumors. These increases have been related to type and tumor grade. This observation does not fully explain the variation within the same tumor grade.

Ki-67 label index is a marker of mitotic activity that can be used as proliferation index. It has been associated with histologic grade and survival rate. Provides a quantitative measure of the tumor proliferation status.

The investigators will perform a retrospective analysis of the clinical charts of patients after brain tumor resection. The study will address the relationship between baseline lactate levels and the proliferation index found in tissues biopsies.

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Conditions studied

  • Brain Tumor
  • Anesthesia

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Keywords

  • Lactate
  • Ki-67
  • Mitotic index
  • Brain tumor
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In context

Brain Neoplasms

1,993 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's enrollment of 100 is close to the median of 100 across 389 observational studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

Ricard Valero is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Craniectomy cases for tumoral and non-tumoral surgery with lactate levels and biopsy information.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Neurosurgical craniectomy cases
  • June 2017 - February 2018
  • Valid lactate information after anesthesia induction
  • Ki-67 label index informed in biopsies
  • Tumor type information confirmed in biopsies

Exclusion criteria

Exclusion Criteria:

  • Incomplete lactate or Ki-67 index information
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Lactate and Ki 67 levels

    Neurosurgical patients between June 2017 and February 2018 for tumoral and non-tumoral craniectomy with lactate levels at the beginning of surgery and Ki-67 index in biopsies.

    Other: Data correlation

Interventions

  • OtherData correlation

    Correlation between lactate levels and Ki-67 index

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What researchers measure

Primary outcomes

  1. Evaluate the correlation between Lactate levels and Ki-67 Index

    Levels of lactate in first blood analysis after anesthesia induction and proliferation index in biopsy results

    Time frame: Within 1 week after data acquisition

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Study locations

1 site
  • Anesthesia department, Hospital Clínic de Barcelona
    Barcelona, 08036, Spain
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2018 to primary completion in Jul 2018, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 24, 2018
First posted
May 21, 2018
StartActual
May 30, 2018
Primary completionActual
Jul 30, 2018
CompletionActual
Aug 2, 2018
Last update
Feb 15, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03531307
Lead sponsor
Ricard Valero
Responsible party
Ricard Valero (Head of Neuroanesthesia. Associated Professor., Fundacion Clinic per a la Recerca Biomédica) — Sponsor-investigator
First posted
May 21, 2018
Start date
May 30, 2018
Primary completion
Jul 30, 2018
Completion
Aug 2, 2018
Last update
Feb 15, 2019

Study contacts

Ricard Valero, Dr.
principal investigator · Hospital Clinic of Barcelona

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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