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Trial record 31 of 303 for:    "Parkes Weber syndrome" OR "Vascular Malformations"

Normal Saline Vrs Balanced i.v. Fluids in Neurosurgery

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ClinicalTrials.gov Identifier: NCT03429127
Recruitment Status : Enrolling by invitation
First Posted : February 12, 2018
Last Update Posted : February 12, 2018
Sponsor:
Collaborator:
Sisters of Mercy University Hospital
Information provided by (Responsible Party):
Natasa Kovac, Clinical Hospital Centre Zagreb

Brief Summary:
The purpose of this study was to investigate whether the balanced fluids therapy change plasma osmolality in neurosurgical procedures due to brain tumors, meningeomas and arterio-venous malformation.

Condition or disease Intervention/treatment
Benign Neoplasms Vascular Malformations, Brain Other: Normal saline Other: Balanced fluid

Detailed Description:
Normal saline or 0.9% sodium chloride solution is the most commonly used intravenous fluid worldwide and its composition are 154 mmol Na+ and 154 mmol Cl- per litter with osmolality of 308 mOsmol/L. That composition is not "normal" because plasma contains potassium in range between 137-146 mmol/L, and chloride in range between 98-106 mmol/L, with plasma osmolality of 280-295 mOsmol/kg. Recently published data suggested detrimental effects of chloride rich fluids on renal blood flow and glomerular filtration rate, urine output and acute kidney injury. One alternative to saline solution is a buffered, balanced, crystalloid solution with an electrolyte composition similar to plasma and osmolality between 286-295 mOsmol/L. Someone could indicate that such balanced solutions are not suitable for neurosurgical patients because of a possible impact on the brain edema development.

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of Normal Saline and Balanced Crystalloid Intravenous Therapy During Neurosurgery
Actual Study Start Date : March 23, 2017
Estimated Primary Completion Date : October 23, 2018
Estimated Study Completion Date : February 23, 2019


Group/Cohort Intervention/treatment
Normal saline fluid group
The patients in this group will receive up to 2000 ml of normal saline during neurosurgical operation.
Other: Normal saline
Plasma osmolality, acid base status and electrolytes after application up to 2000 ml of normal saline during neurosurgical operation
Other Name: 0,9 % sodium chloride

Balanced fluid group
The patients in this group will receive up to 2000 ml of balanced fluids during neurosurgical operation.
Other: Balanced fluid
Plasma osmolality, acid base status and electrolytes after application of up to 2000 ml balanced fluids during neurosurgical operation
Other Name: Plasma-Lyte 148




Primary Outcome Measures :
  1. Changes in acid base pH status [ Time Frame: During operation and immediately after operation ]
    Changes in acid base pH status after each 500 ml of normal saline vrs. balanced fluid


Secondary Outcome Measures :
  1. Changes in electrolytes (sodium and chloride) [ Time Frame: During operation and immediately after operation ]
    Electrolytes changes (sodium and chloride) after each 500 ml of normal saline vrs. balanced fluid


Other Outcome Measures:
  1. Plasma osmolality [ Time Frame: Immediately after operation ]
    Whether the applied fluids affect plasma osmolality



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who underwent neurosurgical procedure because of brain tumor, meningeoma and vascular malformation. And without signs of elevated intracranial pressure and any history of kidney or heart disease.
Criteria

Inclusion Criteria:

  • Patients with brain tumor, meningeomas and vascular malformation.

Exclusion Criteria:

  • Patients with signs of elevated intracranial pressure; History of kidney disease, History of heart disease

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): NCT03429127


Locations
Croatia
UHC Zgagreb
Zagreb, Croatia, 10000
Sponsors and Collaborators
Clinical Hospital Centre Zagreb
Sisters of Mercy University Hospital
Investigators
Principal Investigator: Natasa Kovac, M.D. UHC Zagreb

Responsible Party: Natasa Kovac, Natasa Kovac, M.D., Anesthesiologyst and intensive care medicine subspecialist, Clinical Hospital Centre Zagreb
ClinicalTrials.gov Identifier: NCT03429127     History of Changes
Other Study ID Numbers: 02/21 AG
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Natasa Kovac, Clinical Hospital Centre Zagreb:
balanced fluids, neurosurgery, plasma osmolality

Additional relevant MeSH terms:
Vascular Malformations
Central Nervous System Vascular Malformations
Congenital Abnormalities
Neoplasms
Cardiovascular Abnormalities
Cardiovascular Diseases
Nervous System Malformations
Nervous System Diseases
Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions