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Hyperlactatemia During and After Tumorcraniotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04410315
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Alexandra Vassilieva, 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.

Condition or disease Intervention/treatment
Hyperlactatemia Brain Tumor Surgery Anesthesia Other: Serum-lactate < 2,2 mmol/L Other: Serum-lactate >/= 2,2 mmol/L

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.

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Elevated Serum-lactate in Patients With Brain Tumor During and After Elective Craniotomy: an Observational Clinical Study of Postoperative Patient Outcome.
Actual Study Start Date : July 28, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Tumorcraniotomy patients Other: Serum-lactate < 2,2 mmol/L
Bloodgas analysis every hour from start surgery until recovery ward discharge

Other: Serum-lactate >/= 2,2 mmol/L
Bloodgas analysis every hour from start surgery until recovery ward discharge




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing tumorcraniotomy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410315


Locations
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Denmark
Department of Neuroanesthesiology, Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Alexandra Vassilieva, MD    +4526525373    alexandra.vassilieva@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
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Responsible Party: Alexandra Vassilieva, Principal investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04410315    
Other Study ID Numbers: Prosp.Laktat.Tumorkraniotomi
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Hyperlactatemia
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases