Hyperlactatemia During and After Tumorcraniotomy

August 16, 2022 updated by: Alexandra Vassilieva, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Department of Neuroanesthesiology, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing tumorcraniotomy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurological disability
Time Frame: Change from baseline mRS at 30 days after surgery
Modified Rankin Scale (Scoring 0-6, high scores meaning worse outcome)
Change from baseline mRS at 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: 1 year
In days from admission to discharge.
1 year
Mortality
Time Frame: After 30 days, 6 months and 5 years
After 30 days, 6 months and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2020

Primary Completion (Actual)

February 18, 2022

Study Completion (Actual)

February 18, 2022

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prosp.Laktat.Tumorkraniotomi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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