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

Cerebral Edema Clinical Trial

Official title:

Randomized Controlled Trial for the Use of Patient Tailored Balanced Hypertonic Solutions in Patients With Cerebral Edema

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03330704
• Other study ID #: IRB-43653
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: November 28, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: February 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Edema
• Cerebral Edema
• Saline Solution, Hypertonic

Intervention

Drug:
• 3% Sodium Chloride
3% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure
• 23.4% Sodium Chloride
23.4% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure
• 8.4% Sodium Bicarbonate
8.4% sodium bicarbonate will be infused into patients for the treatment or prevention of raised intracranial pressure

Locations

Country	Name	City	State
United States	Stanford University Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Diringer MN, Zazulia AR. Osmotic therapy: fact and fiction. Neurocrit Care. 2004;1(2):219-33. Review. — View 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. — View 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. Review. — View 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. — View Citation

Wilcox CS. Regulation of renal blood flow by plasma chloride. J Clin Invest. 1983 Mar;71(3):726-35. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Urine output	Urine output will be collected and measured quantitatively in milliliter units.	Urine output during active hypertonic fluid infusion will be measured. This outcome measure will be assessed 1 week after study enrollment