Hyperlactatemia During and After Tumorcraniotomy | NCT04410315

Studies
Hyperlactatemia During and After Tumorcraniotomy

NCT04410315

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Aug 17, 2022Actual

Enrollment

450Actual

Phase

Not provided

Conditions

Hyperlactatemia
Brain Tumor
Surgery
Anesthesia

Interventions

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

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 28, 2020Actual

Primary Completion Date

Feb 18, 2022Actual

Completion Date

Feb 18, 2022Actual

First Submitted Date

May 14, 2020

First Submission Date that Met QC Criteria

May 29, 2020

First Posted Date

Jun 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2022

Last Update Posted Date

Aug 17, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

450Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tumorcraniotomy patients			Other: Serum-lactate < 2,2 mmol/L Other: Serum-lactate >/= 2,2 mmol/L

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serum-lactate < 2,2 mmol/L	Other	Bloodgas analysis every hour from start surgery until recovery ward discharge	Tumorcraniotomy patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing tumorcraniotomy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neuroanesthesiology, Rigshospitalet		Copenhagen			Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065906	Hyperlactatemia
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided