Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408077
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-03
Brief Title:
Regulation of Extracellular Sodium in End Stage Renal Disease Upon Volume and Electrolyte Challenges
Sponsor:
University of Cologne
Organization:
University of Cologne
Study Overview
Official Title:
Regulation of Extracellular Sodium in End Stage Renal Disease Upon Volume and Electrolyte Challenges - a Prospective Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESERVE
Brief Summary:
Hyponatremia is the most common electrolyte disorder of all and can be observed in more than 30 of all patients in hospitals Osmotic homeostasis of body fluids is essential for survival of all living creatures It is widely accepted that extra- and intracellular osmolalities are in equilibrium at all times and thus changes in the extracellular osmolality will lead to either shrinkage or swelling of cells which can be detrimental In severe cases it can lead to swelling of the brain and death Even in less dramatic scenarios symptoms such as epileptic seizures headaches depression and dizziness exist leading to an increased risk of fractures hospital admissions and a considerable burden for affected patients
As short-term defense against osmotic stress each individual cell is capable of actively externalizing or internalizing osmotically active solutes which restores normal or near-normal cell volume at the expense of an altered milieu interior Obviously there must be limitations to this strategy if intracellular integrity is meant to be kept stable It has therefore been postulated that apart from this cell-immanent mechanism extracellular and intracellular electrolyte stores could assist in buffering osmotic imbalances
The Edelman formula states that extracellular sodium is determined by the total amount of exchangeable body sodium the major extracellular cation plus potassium the major intracellular cation divided by total body water Several studies have shown that it only partially explains the changes in patients outside the osmotic equilibrium
To better understand these physiological responses might not only promote the researchers insight into the most basic cellular self-defense systems by measuring and comparing extra- and intracellular electrolyte concentrations with estimated changes in a patient that will be intravenously challenged with either water or sodium chloride 3
The evolution over time of extra- and intracellular sodium and other electrolytes will be assessed quantitatively in patients with impaired renal function after water or sodium chloride NaCl administration
As short-term defense against osmotic stress each individual cell is capable of actively externalizing or internalizing osmotically active solutes which restores normal or near-normal cell volume at the expense of an altered milieu interior Obviously there must be limitations to this strategy if intracellular integrity is meant to be kept stable It has therefore been postulated that apart from this cell-immanent mechanism extracellular and intracellular electrolyte stores could assist in buffering osmotic imbalances
The Edelman formula states that extracellular sodium is determined by the total amount of exchangeable body sodium the major extracellular cation plus potassium the major intracellular cation divided by total body water Several studies have shown that it only partially explains the changes in patients outside the osmotic equilibrium
To better understand these physiological responses might not only promote the researchers insight into the most basic cellular self-defense systems by measuring and comparing extra- and intracellular electrolyte concentrations with estimated changes in a patient that will be intravenously challenged with either water or sodium chloride 3
The evolution over time of extra- and intracellular sodium and other electrolytes will be assessed quantitatively in patients with impaired renal function after water or sodium chloride NaCl administration
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None