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Intraoperative Goal Directed Fluid Management in Supratentorial Brain Tumor Craniotomy

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ClinicalTrials.gov Identifier: NCT03033706
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Hasanin, Cairo University

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.

Condition or disease Intervention/treatment Phase
Brain Tumor Craniotomy Procedure: Pulse pressure variation guided fluid therapy Procedure: Traditional fluid therapy Procedure: Brain tumor excision Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraoperative Goal Directed Fluid Management Guided by Pulse Pressure Variation in Supratentorial Brain Tumor Craniotomy: a Randomized Controlled Study
Actual Study Start Date : March 25, 2017
Actual Primary Completion Date : January 25, 2018
Actual Study Completion Date : January 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

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: 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.

Procedure: Brain tumor excision
Brain tumor excision under general anesthesia




Primary Outcome Measures :
  1. Evaluation of brain relaxation [ Time Frame: one minute after dural puncture and one minute before dural closure ]
    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 :
  1. volume of intraoperative fluid requirements [ Time Frame: intraoperatively ]
    in litres

  2. Urine output [ Time Frame: intraoperatively ]
    Litres

  3. heart rate [ Time Frame: intraoperatively ]
    in beat per minute

  4. number of episodes of hypotension [ Time Frame: intraoperatively ]
    number of times where the blood pressure decreased by 25% of baseline

  5. arterial blood gases [ Time Frame: one hour postoperatively ]
    partial pressure of oxygen and carbon dioxide

  6. serum lactate [ Time Frame: one hour postoperatively ]
    in mmol per decilitre

  7. Hemoglobin concentration [ Time Frame: one hour postoperatively ]
    in grams per decilitre

  8. prothrombin concentration [ Time Frame: one hour postoperatively ]
    in percent



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033706


Locations
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Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Ahmed Mukhtar, Professor Head of research committee section in anesthesia department

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Responsible Party: Ahmed Hasanin, Lecturer of anesthesia and critical care medicine, Cairo University
ClinicalTrials.gov Identifier: NCT03033706     History of Changes
Other Study ID Numbers: MD-4-2016
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases