NCT01601314

Brief Summary

The purpose of this study is to determine the relationship between magnesium sulphate administration and levels of S100B protein in serum of patients undergoing supratentorial brain parenchymal resection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 18, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

5.2 years

First QC Date

May 10, 2012

Last Update Submit

January 12, 2018

Conditions

Seizures (Incl Subtypes)Brain Tumor

Outcome Measures

Primary Outcomes (1)

  • Serum S100B protein

    2 hours after the end of the surgery

Secondary Outcomes (7)

  • Serum S100B protein

    1 hour before surgery; daily postoperative until day 10.

  • Serum Specific Neuronal Enolase (SNE)

    1 hour before surgery; 2 hours after end of surgery; every 48 hours until day 10

  • Improvement on Magnetic Resonance Imaging

    within the month prior to surgery; early postoperative; 6 months postoperative

  • Improvement on Neuropsychological Assessment

    within the month prior to surgery; early postoperative; 1, 6 and 12 months postoperative

  • Glasgow Outcome Scale

    6 and 12 month postoperative

  • +2 more secondary outcomes

Study Arms (2)

magnesium sulphate

EXPERIMENTAL

The patients who are going to receive Magnesium Sulphate

Drug: Magnesium Sulfate

Control

PLACEBO COMPARATOR

Patients who are going to receive Sodium Chloride 0.9%

Other: Sodium Chloride

Interventions

Magnesium SulfateDRUG

At the beginning of the neurosurgery, the subjects are going to receive one 4gr bolus in Sodium Chloride 100 mL, lasting 20 minutes, intravenously. After that, a intravenously perfusion of Magnesium Sulfate 20 gr, in Sodium Chloride 1000 mL, lasting 24 hours, will be started.

magnesium sulphate
Sodium ChlorideOTHER

At the beginning of the neurosurgery, the subjects are going to receive a bolus of Sodium Chloride 100 mL, lasting 20 minutes, intravenously. After that, a intravenously perfusion of Sodium Chloride 1000 mL, lasting 24 hours, will be started.

Control

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and females older than 18 years.
  • Undergoing supratentorial parenchyma resection surgery.
  • Capable of collaborate on probes and explorations included in the study.
  • Signature the written informed consent form.

You may not qualify if:

  • Life expectancy less than 12 months due to the suspected histological type of tumour.
  • Hypothalamic-pituitary axis illness.
  • Presence of Melanoma previously.
  • Glomerular filtration rate less than 60 mL/min.
  • Thyroid or parathyroid glands pathology.
  • Myasthenia gravis.
  • Respiratory depression.
  • Pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

SeizuresBrain Neoplasms

Interventions

Magnesium SulfateSodium Chloride

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Study Officials

  • Neus Fabregas, MD PhD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Manager

Study Record Dates

First Submitted

May 10, 2012

First Posted

May 18, 2012

Study Start

October 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

ES(1)