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

Sponsor
Trakya University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04584827
Collaborator
(none)
100
1
24
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Evaluation of Lactate in Patients Undergoing Glial and Non Glial Mass Surgery With Craniotomy
Actual Study Start Date :
Dec 10, 2019
Anticipated Primary Completion Date :
Jul 10, 2021
Anticipated Study Completion Date :
Dec 10, 2021

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. lactate level [change from operation to post-op second day (4 time)]

      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.

    Secondary Outcome Measures

    1. Glasgow Outcome Scale [30 days after the operation (1 time)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Trakya University Edirne Centrum Turkey 22030

    Sponsors and Collaborators

    • Trakya University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Onur Kucuk, Department of anesthesiology and reanimation, Research Assistant, Trakya University
    ClinicalTrials.gov Identifier:
    NCT04584827
    Other Study ID Numbers:
    • TÜTF-BAEK 2019/450
    First Posted:
    Oct 14, 2020
    Last Update Posted:
    Apr 27, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Onur Kucuk, Department of anesthesiology and reanimation, Research Assistant, Trakya University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 27, 2021