Intraoperative Goal Directed Fluid Management in Supratentorial Brain Tumor Craniotomy

Intraoperative Goal Directed Fluid Management Guided by Pulse Pressure Variation in Supratentorial Brain Tumor Craniotomy: a Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Brain Tumor; Craniotomy
• Intervention / Treatment: Procedure: Pulse pressure variation guided fluid therapy; Procedure: Brain tumor excision; Procedure: Traditional fluid therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study group; 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%.	Procedure: Pulse pressure variation guided fluid therapy; Pulse pressure variation obtained from invasive blood pressure waveform; Procedure: Brain tumor excision; Brain tumor excision under general anesthesia
Placebo Comparator: Control group; 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.	Procedure: Brain tumor excision; Brain tumor excision under general anesthesia; Procedure: Traditional fluid therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one minute after dural puncture and one minute before dural closure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2017
• Primary Completion (Actual): January 25, 2018
• Study Completion (Actual): January 30, 2018

Study Registration Dates

• First Submitted: January 20, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: MD-4-2016

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