Hyperlactatemia During and After Tumorcraniotomy

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04410315
• Other study ID #: Prosp.Laktat.Tumorkraniotomi
• Status: Completed
• Start date: July 28, 2020
• Est. completion date: February 18, 2022

Study information

• Verified date: August 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: February 18, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Brain Neoplasms
• Brain Tumor
• Hyperlactatemia
• Surgery

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Neuroanesthesiology, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological disability	Modified Rankin Scale (Scoring 0-6, high scores meaning worse outcome)	Change from baseline mRS at 30 days after surgery
Secondary	Length of hospital stay	In days from admission to discharge.	1 year
Secondary	Mortality		After 30 days, 6 months and 5 years