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Intraoperative Goal Directed Fluid Management in Supratentorial Brain Tumor Craniotomy

Primary Purpose

Brain Tumor, Craniotomy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pulse pressure variation guided fluid therapy
Traditional fluid therapy
Brain tumor excision
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled for supratentorial mass excision will be enrolled in the study.

Exclusion Criteria:

  • Patients with arrhythmias, pulmonary hypertension, impaired cardiac contractility, impaired liver or kidney function, and patients with BMI above 40 will be excluded.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Study group

Control group

Arm Description

Brain tumor excision under general anesthesia. Intervention (Pulse pressure variation guided fluid therapy): Study group will receive restricted fluid management with 1 ml/Kg/hr with concomitant PPV monitoring. PPV will be measured using invasive blood pressure monitor. Fluid bolus of 3 ml/Kg of ringer solution will be administrated whenever PPV is higher than 13%.

Brain tumor excision under general anesthesia. Intervention (Traditional fluid therapy): Control Group will receive standard fluid management of 4 ml/Kg/hr ringer solution plus rescue fluid bolus of 200 ml Ringer solution if Mean arterial pressure decreased by 20% with central venous pressure less than 4 mmHg.

Outcomes

Primary Outcome Measures

Evaluation of brain relaxation
A 4-point scale will be performed as follows: grade 1, perfectly relaxed; grade 2, satisfactorily relaxed; grade 3, firm brain; grade 4, bulging brain.

Secondary Outcome Measures

volume of intraoperative fluid requirements
in litres
Urine output
Litres
heart rate
in beat per minute
number of episodes of hypotension
number of times where the blood pressure decreased by 25% of baseline
arterial blood gases
partial pressure of oxygen and carbon dioxide
serum lactate
in mmol per decilitre
Hemoglobin concentration
in grams per decilitre
prothrombin concentration
in percent

Full Information

First Posted
January 20, 2017
Last Updated
November 21, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03033706
Brief Title
Intraoperative Goal Directed Fluid Management in Supratentorial Brain Tumor Craniotomy
Official Title
Intraoperative Goal Directed Fluid Management Guided by Pulse Pressure Variation in Supratentorial Brain Tumor Craniotomy: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 25, 2017 (Actual)
Primary Completion Date
January 25, 2018 (Actual)
Study Completion Date
January 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pulse pressure variation (PPV) to standard fluid management (4ml/Kg/hr) in patients undergoing supratentorial mass excision. The investigators hypothesize that in these procedures, goal-directed fluid therapy (GDT) might improve brain relaxation, and patient hemodynamics intra and postoperatively.
Detailed Description
Neurosurgical operations are characterized by major fluid shift, frequent use of diuretics, and prolonged operative time. The role of fluid therapy in these patients is very critical, hypovolemia might lead to brain hypoperfusion and over-transfusion might lead increased intracranial tension. All these factors make fluid management in these procedures complex and challenging. Evidence on the optimum protocol for intraoperative fluid management in neurosurgical patients is still lacking. Goal-directed therapy (GDT) in the operating room is a term used to describe the use of cardiac output or similar parameters to guide intravenous fluid and inotropic therapy. Although GDT was well reported in many procedures, its benefit in neurosurgical operations is not well studied. Pulse pressure variation (PPV) is a famous dynamic method of fluid responsiveness. PPV is simply calculated by dividing the largest pulse pressure (PPmax - PPmin) by the average pulse pressure (PPmax + PPmin /2) and expressed as percentage. PPV was previously used in GDT in major abdominal surgery with good performance. The aim of this study is to compare the restricted fluid approach (1 ml/Kg/hr) guided by PPV to standard fluid management (4ml/Kg/hr) in patients undergoing supratentorial mass excision. The investigators hypothesize that in these procedures GDT might improve brain relaxation, and patient hemodynamics intra and postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Craniotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Active Comparator
Arm Description
Brain tumor excision under general anesthesia. Intervention (Pulse pressure variation guided fluid therapy): Study group will receive restricted fluid management with 1 ml/Kg/hr with concomitant PPV monitoring. PPV will be measured using invasive blood pressure monitor. Fluid bolus of 3 ml/Kg of ringer solution will be administrated whenever PPV is higher than 13%.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Brain tumor excision under general anesthesia. Intervention (Traditional fluid therapy): Control Group will receive standard fluid management of 4 ml/Kg/hr ringer solution plus rescue fluid bolus of 200 ml Ringer solution if Mean arterial pressure decreased by 20% with central venous pressure less than 4 mmHg.
Intervention Type
Procedure
Intervention Name(s)
Pulse pressure variation guided fluid therapy
Intervention Description
Pulse pressure variation obtained from invasive blood pressure waveform
Intervention Type
Procedure
Intervention Name(s)
Traditional fluid therapy
Intervention Description
4 ml/Kg/hr ringer solution plus rescue fluid bolus of 200 ml Ringer solution if Mean arterial pressure decreased by 20% with central venous pressure less than 4 mmHg.
Intervention Type
Procedure
Intervention Name(s)
Brain tumor excision
Intervention Description
Brain tumor excision under general anesthesia
Primary Outcome Measure Information:
Title
Evaluation of brain relaxation
Description
A 4-point scale will be performed as follows: grade 1, perfectly relaxed; grade 2, satisfactorily relaxed; grade 3, firm brain; grade 4, bulging brain.
Time Frame
one minute after dural puncture and one minute before dural closure
Secondary Outcome Measure Information:
Title
volume of intraoperative fluid requirements
Description
in litres
Time Frame
intraoperatively
Title
Urine output
Description
Litres
Time Frame
intraoperatively
Title
heart rate
Description
in beat per minute
Time Frame
intraoperatively
Title
number of episodes of hypotension
Description
number of times where the blood pressure decreased by 25% of baseline
Time Frame
intraoperatively
Title
arterial blood gases
Description
partial pressure of oxygen and carbon dioxide
Time Frame
one hour postoperatively
Title
serum lactate
Description
in mmol per decilitre
Time Frame
one hour postoperatively
Title
Hemoglobin concentration
Description
in grams per decilitre
Time Frame
one hour postoperatively
Title
prothrombin concentration
Description
in percent
Time Frame
one hour postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for supratentorial mass excision will be enrolled in the study. Exclusion Criteria: Patients with arrhythmias, pulmonary hypertension, impaired cardiac contractility, impaired liver or kidney function, and patients with BMI above 40 will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Mukhtar, Professor
Organizational Affiliation
Head of research committee section in anesthesia department
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Intraoperative Goal Directed Fluid Management in Supratentorial Brain Tumor Craniotomy

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