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

NCT03330704 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: IRB-43653
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Edema; Saline Solution, Hypertonic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Urine output

  Urine output during active hypertonic fluid infusion will be measured. This outcome measure will be assessed 1 week after study enrollment

Study Arms (2)

Standard Therapy

ACTIVE COMPARATOR

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

Balanced Therapy

EXPERIMENTAL

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; Drug: 8.4% Sodium Bicarbonate

Interventions

3% Sodium Chloride DRUG

3% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure

Standard Therapy

23.4% Sodium Chloride DRUG

23.4% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure

Balanced Therapy

8.4% Sodium Bicarbonate DRUG

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

Balanced Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Hospital

Stanford, California, 94305, United States

Location

Related Publications (5)

• Wilcox CS. Regulation of renal blood flow by plasma chloride. J Clin Invest. 1983 Mar;71(3):726-35. doi: 10.1172/jci110820.

  PMID: 6826732 BACKGROUND

• 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.

  PMID: 18090381 BACKGROUND

• Diringer MN, Zazulia AR. Osmotic therapy: fact and fiction. Neurocrit Care. 2004;1(2):219-33. doi: 10.1385/NCC:1:2:219.

  PMID: 16174920 BACKGROUND

• 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.

  PMID: 28042364 BACKGROUND

• 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.

  PMID: 23636658 BACKGROUND

MeSH Terms

Conditions

Brain Edema

Interventions

Sodium Chloride; Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic

Study Officials

• Tim Angelotti, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: November 6, 2017
• Study Start: November 28, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 19, 2020

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)