NCT03033706

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 25, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

10 months

First QC Date

January 20, 2017

Last Update Submit

November 21, 2018

Conditions

Brain TumorCraniotomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • volume of intraoperative fluid requirements

    intraoperatively

  • Urine output

    intraoperatively

  • heart rate

    intraoperatively

  • number of episodes of hypotension

    intraoperatively

  • arterial blood gases

    one hour postoperatively

  • +3 more secondary outcomes

Study Arms (2)

Study group

ACTIVE COMPARATOR

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 therapyProcedure: Brain tumor excision

Control group

PLACEBO COMPARATOR

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 therapyProcedure: Brain tumor excision

Interventions

Pulse pressure variation guided fluid therapyPROCEDURE

Pulse pressure variation obtained from invasive blood pressure waveform

Study group
Traditional fluid therapyPROCEDURE

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.

Control group
Brain tumor excisionPROCEDURE

Brain tumor excision under general anesthesia

Control groupStudy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ahmed Mukhtar, Professor

    Head of research committee section in anesthesia department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and critical care medicine

Study Record Dates

First Submitted

January 20, 2017

First Posted

January 27, 2017

Study Start

March 25, 2017

Primary Completion

January 25, 2018

Study Completion

January 30, 2018

Last Updated

November 23, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)