NCT04410315

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 28, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2022

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

1.6 years

First QC Date

May 14, 2020

Last Update Submit

August 16, 2022

Conditions

HyperlactatemiaBrain TumorSurgeryAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Neurological disability

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

    Change from baseline mRS at 30 days after surgery

Secondary Outcomes (2)

  • Length of hospital stay

    1 year

  • Mortality

    After 30 days, 6 months and 5 years

Study Arms (1)

Tumorcraniotomy patients

Other: Serum-lactate < 2,2 mmol/LOther: Serum-lactate >/= 2,2 mmol/L

Interventions

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

Bloodgas analysis every hour from start surgery until recovery ward discharge

Tumorcraniotomy patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing tumorcraniotomy

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neuroanesthesiology, Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

HyperlactatemiaBrain Neoplasms

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 14, 2020

First Posted

June 1, 2020

Study Start

July 28, 2020

Primary Completion

February 18, 2022

Study Completion

February 18, 2022

Last Updated

August 17, 2022

Record last verified: 2022-08

Locations

DK(1)