An observational study in Hyperlactatemia, Brain Tumor and Surgery, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-17.
Sponsored by Rigshospitalet, Denmark · Observational
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.
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.
50 studies on the registry are indexed under Hyperlactatemia; 7 are open to participants now.
This study's enrollment of 450 is above the median of 136 across 17 observational studies indexed under Hyperlactatemia.
Browse Hyperlactatemia studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing tumorcraniotomy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Serum-lactate < 2,2 mmol/L · Other: Serum-lactate >/= 2,2 mmol/L
Bloodgas analysis every hour from start surgery until recovery ward discharge
Bloodgas analysis every hour from start surgery until recovery ward discharge
Neurological disability
Modified Rankin Scale (Scoring 0-6, high scores meaning worse outcome)
Time frame: Change from baseline mRS at 30 days after surgery
Length of hospital stay
In days from admission to discharge.
Time frame: 1 year
Mortality
Time frame: After 30 days, 6 months and 5 years
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jul 2020 to primary completion in Feb 2022, 18 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.