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

NCT03330704 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2020-03-19

No results posted yet for this study

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

Interventions

DRUG

3% Sodium Chloride

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

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

Sponsors & Collaborators

Principal Investigators

  • Tim Angelotti, MD, PhD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-28
Primary Completion
2020-01-01
Completion
2020-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03330704 on ClinicalTrials.gov