Hyperlactatemia During and After Tumorcraniotomy

Completed

• Conditions: Anesthesia; Hyperlactatemia; Surgery; Brain Tumor
• Interventions: Other: Serum-lactate < 2,2 mmol/L; Other: Serum-lactate >/= 2,2 mmol/L

• Registration Number: NCT04410315
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-01
• Study Start: 2020-07-28
• Primary Completion: 2022-02-18
• Study Completion: 2022-02-18
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tumorcraniotomy patients	Serum-lactate >/= 2,2 mmol/L	-
Tumorcraniotomy patients	Serum-lactate < 2,2 mmol/L	-

Primary Outcome Measures

Name	Time	Method
Neurological disability	Change from baseline mRS at 30 days after surgery	Modified Rankin Scale (Scoring 0-6, high scores meaning worse outcome)

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	1 year	In days from admission to discharge.
Mortality	After 30 days, 6 months and 5 years

Trial Locations

Locations (1)

Department of Neuroanesthesiology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark