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

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04584827
• Other study ID #: TÜTF-BAEK 2019/450
• Status: Completed
• Start date: December 10, 2019
• Est. completion date: July 10, 2022

Study information

• Verified date: January 2023
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 10, 2022
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Having an intracranial mass operation with craniotomy

2. No history of congestive heart failure

3. No kidney and liver dysfunction

4. Not pregnant

5. Not taking inotropic drugs during the operation

6. Receiving less than four red blood product replacements during the operation

Exclusion Criteria:

1. Patients with a history of congestive heart failure

2. Patients with kidney and liver dysfunction

3. Patients who need an inotropic agent to adjust blood pressure during the operation

4. Patients who have undergone four or more red blood product transfusions during the operation

5. Pregnant patients

Related Conditions & MeSH terms

• Brain Tumor
• Lactate
• Post-Op Complication
• Postoperative Complications

Intervention

Other:
• lactate level
Lactate, 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.
• Glasgow Outcome Scale
Glasgow 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.

Locations

Country	Name	City	State
Turkey	Trakya University	Edirne	Centrum

Sponsors (1)

Lead Sponsor	Collaborator
Trakya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lactate level	Lactate, 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.	change from operation to post-op second day (4 time)
Secondary	Glasgow Outcome Scale	Glasgow 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. Glasgow Outcome Scale is a five-point scale. 1 point is considered death and five points as good recovery. As the score increases, morbidity and mortality decrease.	30 days after the operation (1 time)