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NCT Number: NCT04410315

Hyperlactatemia During and After Tumorcraniotomy

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.

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Key information

Conditions

Hyperlactatemia Anesthesia Brain Diseases Brain Neoplasms Brain Tumor Central Nervous System Diseases Central Nervous System Neoplasms Metabolic Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neuroanesthesiology, Rigshospitalet

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum-lactate < 2,2 mmol/L

Other

Bloodgas analysis every hour from start surgery until recovery ward discharge

Serum-lactate >/= 2,2 mmol/L

Other

Bloodgas analysis every hour from start surgery until recovery ward discharge

Primary outcomes

  1. Neurological disability

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

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

Secondary outcomes

  1. Length of hospital stay

    Time frame: 1 year

    In days from admission to discharge.

  2. Mortality

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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2020
Registry last updated
Aug 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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