Clinical Trials Directory

Trials / Completed

CompletedNCT04584827

Evaluation of Lactate in Patients Undergoing Glial and Non Glial Mass Surgery With Craniotomy

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Trakya University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The aim of this study is to determine the effects of the level of metabolites used in routine on mortality and morbidity in patients who will undergo intracranial surgery with craniotomy.

Detailed description

In this study, in patients who are planned to have an intracranial mass operation with craniotomy, their medical histories, demographic features, comorbidities, preoperative radiotherapy treatment, the parameters examined in the preoperative routine will be collected as a file scan (previous operations, GKS, laboratory values). The classification of patients according to the 2016 World Health Organization Central Classification of Nervous System Tumors (WHO-CNS classification) and whether it is glial or non glial will be recorded from the clinical file. Intraoperative; hemodynamic data of patients; heart rate, diastolic, systolic and mean arterial pressures, fluid and blood products delivered, anesthetic and other medications, and blood gas samples will be written from the anesthesia document after the operation is finished. For the study, the application of the anesthesiologist for the patient will not be interfered. If postoperative patients are sent to the intensive care unit, their laboratory values and clinical observations (mortality, morbidity, neurological sequelae, imaging techniques, GOSE (Glasgow outcome skale)) will be recorded. In our study, mortality and morbidity will be evaluated 30 days postoperatively, and if the patient was sent to the service from the intensive care unit in this process, the values in the postoperative clinic (mortality, morbidity, neurological evaluation, imaging techniques, pathology results) will be recorded from the patient document. If the patient was discharged 30 days before, outpatient data will be recorded. The patients will be classified by evaluating the collected data (intraoperative hemodynamic data, blood transfusions, postoperative neurological sequel, postoperative complications and mortality). In our study; the effects of lactate level on mortality and morbidity will be investigated in patients undergoing an intracranial mass operation with general anesthesia.

Conditions

Interventions

TypeNameDescription
OTHERlactate levelLactate, a byproduct of glycolysis, is an indicator of weak tissue perfusion and a useful biomarker with prognostic value in various diseases. Lactate value is calculated by blood gas.
OTHERGlasgow Outcome ScaleGlasgow Outcome Scale; It is a scale developed to categorize people suffering from head trauma or non-traumatic acute brain injury into broad outcome categories. It shows postoperative mortality and morbidity of patients who underwent intracranial surgery.

Timeline

Start date
2019-12-10
Primary completion
2021-12-10
Completion
2022-07-10
First posted
2020-10-14
Last updated
2023-01-19

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04584827. Inclusion in this directory is not an endorsement.