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

Primary Purpose

Cerebral Edema, Saline Solution, Hypertonic

Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
3% Sodium Chloride
23.4% Sodium Chloride
8.4% Sodium Bicarbonate
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Therapy

Balanced Therapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Total volume of intravenous hypertonic fluid administered to the patient
Total hypertonic fluid volume administered to each group of patients measured in milliliters of fluid.

Secondary Outcome Measures

Urine output
Urine output will be collected and measured quantitatively in milliliter units.

Full Information

First Posted
October 23, 2017
Last Updated
March 17, 2020
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03330704
Brief Title
Small-Volume, Patient-Specific, Balanced Hypertonic Fluid Protocol Validation
Official Title
Randomized Controlled Trial for the Use of Patient Tailored Balanced Hypertonic Solutions in Patients With Cerebral Edema
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
lack of eligible study participants
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Edema, Saline Solution, Hypertonic

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Balanced Therapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
3% Sodium Chloride
Intervention Description
3% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure
Intervention Type
Drug
Intervention Name(s)
23.4% Sodium Chloride
Intervention Description
23.4% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure
Intervention Type
Drug
Intervention Name(s)
8.4% Sodium Bicarbonate
Intervention Description
8.4% sodium bicarbonate will be infused into patients for the treatment or prevention of raised intracranial pressure
Primary Outcome Measure Information:
Title
Total volume of intravenous hypertonic fluid administered to the patient
Description
Total hypertonic fluid volume administered to each group of patients measured in milliliters of fluid.
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
Secondary Outcome Measure Information:
Title
Urine output
Description
Urine output will be collected and measured quantitatively in milliliter units.
Time Frame
Urine output during active hypertonic fluid infusion will be measured. This outcome measure will be assessed 1 week after study enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Angelotti, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data
Citations:
PubMed Identifier
6826732
Citation
Wilcox CS. Regulation of renal blood flow by plasma chloride. J Clin Invest. 1983 Mar;71(3):726-35. doi: 10.1172/jci110820.
Results Reference
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PubMed Identifier
18090381
Citation
Toung TJ, Nyquist P, Mirski MA. Effect of hypertonic saline concentration on cerebral and visceral organ water in an uninjured rodent model. Crit Care Med. 2008 Jan;36(1):256-61. doi: 10.1097/01.CCM.0000295306.52783.1E.
Results Reference
background
PubMed Identifier
16174920
Citation
Diringer MN, Zazulia AR. Osmotic therapy: fact and fiction. Neurocrit Care. 2004;1(2):219-33. doi: 10.1385/NCC:1:2:219.
Results Reference
background
PubMed Identifier
28042364
Citation
Erdman MJ, Riha H, Bode L, Chang JJ, Jones GM. Predictors of Acute Kidney Injury in Neurocritical Care Patients Receiving Continuous Hypertonic Saline. Neurohospitalist. 2017 Jan;7(1):9-14. doi: 10.1177/1941874416665744. Epub 2016 Aug 29.
Results Reference
background
PubMed Identifier
23636658
Citation
Neavyn MJ, Boyer EW, Bird SB, Babu KM. Sodium acetate as a replacement for sodium bicarbonate in medical toxicology: a review. J Med Toxicol. 2013 Sep;9(3):250-4. doi: 10.1007/s13181-013-0304-0.
Results Reference
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Small-Volume, Patient-Specific, Balanced Hypertonic Fluid Protocol Validation

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