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Small-Volume, Patient-Specific, Balanced Hypertonic Fluid Protocol Validation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330704
Recruitment Status : Withdrawn (lack of eligible study participants)
First Posted : November 6, 2017
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Tim Angelotti, Stanford University

Brief Summary:
Many patients with traumatic brain injuries (including strokes, blood clots, or other brain injuries) are given concentrated salt water solutions (hypertonic saline) in order to treat brain swelling (cerebral edema). Current therapies consist of a mixture of sodium and chloride, which can lead to high levels of serum chloride and increased total body water. High levels of chloride can cause acidosis, which can cause the body to function sub-optimally. Therefore, the investigators are proposing to use two concentrated solutions in these patients at the same time that will allow for a lower total volume of solution administration and reduce the rise in chloride to prevent acidosis. The main outcome will therefore be the patients sodium level, chloride level and serum pH.

Condition or disease Intervention/treatment Phase
Cerebral Edema Saline Solution, Hypertonic Drug: 3% Sodium Chloride Drug: 23.4% Sodium Chloride Drug: 8.4% Sodium Bicarbonate Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial for the Use of Patient Tailored Balanced Hypertonic Solutions in Patients With Cerebral Edema
Actual Study Start Date : November 28, 2017
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Standard Therapy
This group will receive 3% hypertonic sodium chloride for the management of their cerebral edema. 3% Sodium Chloride is the generic name of this intravenous fluid preparation.
Drug: 3% Sodium Chloride
3% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure

Experimental: Balanced Therapy
This group will undergo two simultaneous infusions. 23.4% sodium chloride and 8.4% sodium bicarbonate will be infused at the same time in various ratios for management of cerebral edema with a balanced approach
Drug: 23.4% Sodium Chloride
23.4% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure

Drug: 8.4% Sodium Bicarbonate
8.4% sodium bicarbonate will be infused into patients for the treatment or prevention of raised intracranial pressure




Primary Outcome Measures :
  1. Total volume of intravenous hypertonic fluid administered to the patient [ Time Frame: The fluid will be infused until the new serum sodium goal is achieved. This outcome measure will be assessed 1 week after study enrollment ]
    Total hypertonic fluid volume administered to each group of patients measured in milliliters of fluid.


Secondary Outcome Measures :
  1. Urine output [ Time Frame: Urine output during active hypertonic fluid infusion will be measured. This outcome measure will be assessed 1 week after study enrollment ]
    Urine output will be collected and measured quantitatively in milliliter units.



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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:

  • Able to consent
  • 18 years or older
  • English speaking
  • Clinical indication (intracranial hypertension from cerebral edema) for hypertonic fluid administration

Exclusion Criteria:

  • Fails to consent
  • < 18 years old
  • Hypertonic therapy not indicated

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): NCT03330704


Locations
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United States, California
Stanford University Hospital
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Tim Angelotti, MD, PhD Stanford University
Publications:
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Responsible Party: Tim Angelotti, Associate Professor of Anesthesiology, Stanford University
ClinicalTrials.gov Identifier: NCT03330704    
Other Study ID Numbers: IRB-43653
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Brain Edema
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases