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Hyperlactatemia During and After Tumorcraniotomy

Elevated Serum-lactate in Patients With Brain Tumor During and After Elective Craniotomy: an Observational Clinical Study of Postoperative Patient Outcome.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04410315
Enrollment
450
Registered
2020-06-01
Start date
2020-07-28
Completion date
2022-02-18
Last updated
2022-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Brain Tumor, Hyperlactatemia, Surgery

Brief 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.

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.

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

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Neurological disabilityChange from baseline mRS at 30 days after surgeryModified Rankin Scale (Scoring 0-6, high scores meaning worse outcome)

Secondary

MeasureTime frameDescription
Length of hospital stay1 yearIn days from admission to discharge.
MortalityAfter 30 days, 6 months and 5 years

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026