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

NCT04584827 | Completed DMC

• 1 other identifier: TÜTF-BAEK 2019/450
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lactate; Brain Tumor; Post-Op Complication

Keywords

lactate; glial and non glial tumor; intracranial; craniotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Glasgow Outcome Scale

  30 days after the operation (1 time)

Study Arms (2)

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; Other: Glasgow Outcome Scale

complication negative (up to 30 days after surgery)

No complications are seen within 30 days and the patient is healthy

Other: lactate level; Other: Glasgow Outcome Scale

Interventions

lactate level OTHER

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.

Also known as: lac

complication negative (up to 30 days after surgery); complication positive (up to 30 days after surgery)

Glasgow Outcome Scale OTHER

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.

Also known as: GOS

complication negative (up to 30 days after surgery); complication positive (up to 30 days after surgery)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Having an intracranial mass operation with craniotomy
• No history of congestive heart failure
• No kidney and liver dysfunction
• Not pregnant
• Not taking inotropic drugs during the operation
• Receiving less than four red blood product replacements during the operation

You may not qualify if:

• Patients with a history of congestive heart failure
• Patients with kidney and liver dysfunction
• Patients who need an inotropic agent to adjust blood pressure during the operation
• Patients who have undergone four or more red blood product transfusions during the operation
• Pregnant patients

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, Centrum, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Brain Neoplasms; Postoperative Complications

Interventions

Lactase; Glasgow Outcome Scale

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

beta-Galactosidase; Galactosidases; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Trauma Severity Indices; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• SEVTAP HEKİMOĞLU ŞAHİN, Professor

  Trakya University

  PRINCIPAL INVESTIGATOR

• ONUR KÜÇÜK, Resident

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of anesthesiology and reanimation, Research Assistant

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: December 10, 2019
• Primary Completion: December 10, 2021
• Study Completion: July 10, 2022
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)