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

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.

Study Overview

• Status: Completed
• Conditions: Brain Tumor; Post-Op Complication; Lactate
• Intervention / Treatment: Other: lactate level; Other: Glasgow Outcome Scale

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Centrum
    • Edirne, Centrum, Turkey, 22030
      • Trakya University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

It is planned to include intracranial mass operations performed by craniotomy between 10 December 2019 - 10 December 2020 in Trakya University Faculty of Medicine, Department of Neurosurgery.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
complication positive (up to 30 days after surgery); Complications: Moderate to severe intracerebral hemorrhage confirmed in a brain CT scan (Midline shift in brain imaging ≥ 3 mm),; İntracranial hypertension requiring post op surgical drainage,; Status epilepticus or seizures,; The need for tracheal intubation or use of mechanical ventilation after surgery,; Decrease in GKS,; Unmanageable agitation that requires restriction or sedation,; Need for respiratory failure and oxygen therapy,; Unexpected serious motor deficit; Died	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.; Other Names: lac; Other: 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.; Other Names: GOS
complication negative (up to 30 days after surgery); No complications are seen within 30 days and the patient is healthy	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.; Other Names: lac; Other: 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.; Other Names: GOS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Trakya University
• Investigators: Principal Investigator: SEVTAP HEKİMOĞLU ŞAHİN, Professor, Trakya University; Principal Investigator: ONUR KÜÇÜK, Resident, Trakya University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): December 10, 2021
• Study Completion (Actual): July 10, 2022

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Estimate): January 19, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: craniotomy; lactate; glial and non glial tumor; intracranial
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: TÜTF-BAEK 2019/450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No