HyperlactatemiaNCT04410315
Hyperlactatemia During and After Tumorcraniotomy
An observational study of Hyperlactatemia and Brain Tumor, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlactatemia, Brain Tumor, Surgery
- What is being tested?
- Serum-lactate < 2,2 mmol/L and Serum-lactate >/= 2,2 mmol/L
- How many people
- 450 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Jul 2020to 18 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing tumorcraniotomy
Who may be able to join
- Age >/= 18 years
- Must undergo elective tumor craniotomy
- Understand oral and written Danish
Who cannot join
- Adults with incapacity
- Stereotactic biopsy
- Lack of informed and signed consent to participate in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperlactatemia, Brain Tumor, Surgery, Anesthesia
- Being tested
- Serum-lactate < 2,2 mmol/L, Serum-lactate >/= 2,2 mmol/L
- Medical subject headings
- Hyperlactatemia, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum-lactate < 2,2 mmol/LOther
Bloodgas analysis every hour from start surgery until recovery ward discharge
Serum-lactate >/= 2,2 mmol/LOther
Bloodgas analysis every hour from start surgery until recovery ward discharge
| Study group | Role | What they receive |
|---|---|---|
| Tumorcraniotomy patients | Not described Receives: Other: Serum-lactate < 2,2 mmol/L; Other: Serum-lactate >/= 2,2 mmol/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological disability
Modified Rankin Scale (Scoring 0-6, high scores meaning worse outcome)
Measured: Change from baseline mRS at 30 days after surgery
Secondary outcomes (2)
Length of hospital stay
In days from admission to discharge.
Measured: 1 year
Mortality
Measured: After 30 days, 6 months and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start28 Jul 2020
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlactatemiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Vassilieva, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410315
- Sponsor's protocol ID
- Prosp.Laktat.Tumorkraniotomi
- Status last verified
- Aug 2022
- First submitted
- 14 May 2020
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elevated Serum-lactate in Patients With Brain Tumor During and After Elective Craniotomy: an Observational Clinical Study of Postoperative Patient Outcome.
- ClinicalTrials.gov ID
- NCT04410315
- Acronym / sponsor ID
- Prosp.Laktat.Tumorkraniotomi
- Conditions
- Hyperlactatemia, Brain Tumor, Surgery, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumorcraniotomy patients | – | Other: Serum-lactate < 2,2 mmol/L, Other: Serum-lactate >/= 2,2 mmol/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing tumorcraniotomy
Key inclusion criteria (3 listed)
- Age >/= 18 years
- Must undergo elective tumor craniotomy
- Understand oral and written Danish
Key exclusion criteria (3 listed)
- Adults with incapacity
- Stereotactic biopsy
- Lack of informed and signed consent to participate in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum-lactate < 2,2 mmol/LBloodgas analysis every hour from start surgery until recovery ward discharge | Other | Tumorcraniotomy patients |
| Serum-lactate >/= 2,2 mmol/LBloodgas analysis every hour from start surgery until recovery ward discharge | Other | Tumorcraniotomy patients |
Primary outcome
Neurological disability
Time frame: Change from baseline mRS at 30 days after surgery
Modified Rankin Scale (Scoring 0-6, high scores meaning worse outcome)
2 secondary outcomes
Length of hospital stay
Time frame: 1 year
Mortality
Time frame: After 30 days, 6 months and 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlactatemia and Brain Tumor, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological disability (time frame: Change from baseline mRS at 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.