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CompletedNCT04410315Updated Aug 17, 2022

Hyperlactatemia During and After Tumorcraniotomy

An observational study in Hyperlactatemia, Brain Tumor and Surgery, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-17.

Sponsored by Rigshospitalet, Denmark · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
450
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to investigate the association between hyperlactatemia and neurological disability, length-of-stay and mortality in patients who undergo tumorcraniotomy. The risk factors that induce lactat accumulation will also be explored.

Read the detailed description

Hyperlactatemia is a frequent occurrence in brain tumor surgery. The existing studies, however, are all retrospective, reporting varying effects on clinical outcome. One study reported new neurological deficitis, some found an association with extended hospital stay, while others found no association with outcome. It is therefore important to conduct a prospective study of hyperlactatemia in this patientgroup.

Participants in this study will follow the standard treatment protocol for tumorcraniotomy, aside from 2-3 additional, perioperative blodgas analyses and 2 standardized measurements of neurological disability.

02

Conditions studied

  • Hyperlactatemia
  • Brain Tumor
  • Surgery
  • Anesthesia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients undergoing tumorcraniotomy

Inclusion criteria

  • Age >/= 18 years
  • Must undergo elective tumor craniotomy
  • Understand oral and written Danish

Exclusion criteria

Exclusion Criteria:

  • Adults with incapacity
  • Stereotactic biopsy
  • Lack of informed and signed consent to participate in study
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
450 participants (actual)
Patient registry
No

Groups and cohorts

  • Tumorcraniotomy patients

    Other: Serum-lactate < 2,2 mmol/L · Other: Serum-lactate >/= 2,2 mmol/L

Interventions

  • OtherSerum-lactate < 2,2 mmol/L

    Bloodgas analysis every hour from start surgery until recovery ward discharge

  • OtherSerum-lactate >/= 2,2 mmol/L

    Bloodgas analysis every hour from start surgery until recovery ward discharge

05

What researchers measure

Primary outcomes

  1. Neurological disability

    Modified Rankin Scale (Scoring 0-6, high scores meaning worse outcome)

    Time frame: Change from baseline mRS at 30 days after surgery

Secondary outcomes

  1. Length of hospital stay

    In days from admission to discharge.

    Time frame: 1 year

  2. Mortality

    Time frame: After 30 days, 6 months and 5 years

06

Study locations

1 site
  • Department of Neuroanesthesiology, Rigshospitalet
    Copenhagen, Denmark
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04410315
Lead sponsor
Rigshospitalet, Denmark
Responsible party
Alexandra Vassilieva (Principal investigator, Rigshospitalet, Denmark) — Principal investigator
First posted
Jun 1, 2020
Start date
Jul 28, 2020
Primary completion
Feb 18, 2022
Completion
Feb 18, 2022
Last update
Aug 17, 2022

Oversight

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

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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