Study on Urea for Treating Low Sodium Levels in Patients with Brain Hemorrhage

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What is this study about?

This clinical trial is focused on studying the treatment of hyponatremia, a condition characterized by low sodium levels in the blood, which can occur during a subarachnoid hemorrhage. A subarachnoid hemorrhage is a type of stroke caused by bleeding on the surface of the brain. The treatment being tested in this study is Urea, which is administered as an oral powder. Urea is a compound that can help increase sodium levels in the blood.

The purpose of the study is to demonstrate the effectiveness of urea in correcting persistent hyponatremia, even when other management strategies have been adequately applied. Participants in the study will receive either urea or a placebo, which is a substance with no active medication. The study will monitor changes in sodium levels before and after the treatment period, which lasts up to five days. The study will also look at how much sodium intake is needed to correct the sodium levels, the mechanism of action of urea, and any potential side effects.

Throughout the study, researchers will assess the impact of the treatment on the length of hospital stay and the neurological outcomes three months after starting the treatment. They will also evaluate how quickly the sodium levels are corrected and whether the correction persists 48 hours after stopping the treatment. This trial aims to provide valuable insights into the management of hyponatremia in patients with subarachnoid hemorrhage.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria. Participants must be aged 18 or over and have a condition known as hyponatremia during a subarachnoid hemorrhage. This means having a low sodium level in the blood, less than 135 mmol/L, despite proper salt intake management.

2 treatment initiation

The treatment involves taking a medication called urea, which is administered as an oral powder. The purpose of this treatment is to help correct the low sodium levels in the blood.

The dosage, frequency, and duration of the urea administration are determined by the study protocol and will be explained by the healthcare team.

3 monitoring and assessments

Throughout the study, regular monitoring of sodium levels in the blood is conducted. This includes measuring the sodium level before starting the treatment and on the day the treatment is stopped.

Additional assessments may include evaluating the amount of sodium intake needed to correct the sodium levels, studying how urea works in the body, and assessing any side effects of the treatment.

4 treatment discontinuation

The treatment is discontinued according to the study protocol. The impact of stopping the treatment on sodium levels is observed for 48 hours after discontinuation.

The healthcare team will provide guidance on what to expect during this phase.

5 follow-up evaluations

Follow-up evaluations are conducted to assess the long-term effects of the treatment. This includes evaluating the impact on the duration of hospital stay and neurological outcomes three months after joining the study.

Any adverse effects experienced during the study are also assessed and documented.

Who Can Join the Study?

Patients must be 18 years or older.
Patients must have experienced a subarachnoid hemorrhage (SAH), which is bleeding in the space around the brain, that is non-traumatic (not caused by an injury).
Patients must have hyponatremia, which means low sodium levels in the blood, defined as a sodium level of less than 135 mmol/L.
Patients must have a high natriuresis, which means a high level of sodium in the urine, greater than 250 mmol/day, even though their salt intake is well-managed.
Both male and female patients can participate.

Who Cannot Join the Study?

Patients with hyponatremia (low sodium levels in the blood) caused by a subarachnoid hemorrhage (bleeding in the space around the brain) cannot participate if their condition is not persistent despite adequate management.
Patients who are not within the specified age range for the study cannot participate.
Patients who belong to a vulnerable population group are not eligible to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
CHU Grenoble Alpes	La Tronche	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Not recruiting	03.12.2020

Trial locations

Investigated drugs:

Urea

Urea is a medication used in this clinical trial to help treat a condition called hyponatremia, which is when there is not enough sodium in the blood. This can happen after a type of bleeding in the brain known as subarachnoid hemorrhage. Urea works by helping the body get rid of extra water, which can help increase the sodium levels in the blood. The goal of using urea in this trial is to see if it can effectively correct low sodium levels when other treatments have not worked well enough.

Investigated diseases:

Hyponatremia during subarachnoid hemorrhage – Hyponatremia is a condition characterized by low sodium levels in the blood. During a subarachnoid hemorrhage, which is bleeding in the space surrounding the brain, hyponatremia can occur due to the body’s response to stress and injury. This condition can lead to symptoms such as confusion, headaches, and muscle weakness. The progression involves a decrease in blood sodium levels, which can affect brain function and overall fluid balance in the body. If not addressed, it can lead to more severe neurological symptoms. The condition requires careful monitoring of sodium levels to prevent complications.

Trial ID:

2024-518532-36-00

Protocol code:

38RC19.189

NCT ID:

NCT04552873

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Urea for Treating Low Sodium Levels in Patients with Brain Hemorrhage

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