Clinical trial NCT04744987: Changes in Serum Creatinine Levels Can Help Distinguish Hypovolemic From Euvolemic Hyponatremia
Official title: Changes in Serum Creatinine Levels Can Help Distinguish Hypovolemic From Euvolemic Hyponatremia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyponatremia
Hypovolemia
SIADH
Keywords: hyponatremia diagnosis
serum creatinine;
hypovolemic hyponatremia
euvolemic hyponatremia
SIAD
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients presenting with hyponatremia, followed in the monographic Hyponatremia outpatient clinic of the Endocrinology and Nutrition Department of the Hospital Clínico San Carlos, Madrid, Spain. Patients were attended from January 1st 2014 through November 30th 2019.

Brief summary: Retrospective study that analyzes the changes in serum creatinine as a tool to correctly classify the volemic status volemic status (euvolemia vs hypovolemia) of the patients with hyponatremia.

Detailed description: This study evaluates the usefulness of the changes in serum creatinine in differentiating between euvolemia and hypovolemia in hyponatremic patients. Changes in serum creatinine were retrospectively analyzed . The latter was calculated subtracting the serum creatinine value of eunatremia from that of hyponatremia, and was categorized as an increase when it was "positive", or "decrease/no change" when it was negative or equal to zero. The percentual change in serum creatinine was also calculated.

Two groups of patients were selected for the current study. First group was conformed by patients with hypovolemic hyponatremia, and second group by patients with euvolemic hyponatremia. Data from eunatremia as well as the hyponatremic episode were collected. Both groups were matched in Receiver operating characteristic curve analyzes where both arithmetical and percentual changes in serum creatinine were assessed and cut-off points were selected for an additional Odd Ratio analysis.

Eligibility criteria: Inclusion Criteria:

* Patients with hypovolemic hyponatremia secondary to any cause
* Patients with euvolemic hyponatremia caused by Syndrome of inappropriate antidiuresis
* Complete clinical volemia assessment during hyponatremia.
* Presence of serum creatinine measured in eunatremia as well as in hyponatremic episodes.

Exclusion Criteria:

* Pregnants.
* Patients with a prior history of diabetes, advanced chronic kidney disease (glomerular filtrate rate below 30 ml/min), cirrhosis, or heart failure were excluded.
* Patients with hypervolemic hyponatremia.

Primary outcomes:
measure: Diagnostic Accuracy of the changes in serum creatinine for volemic classification of hyponatremia
timeFrame: 4 months
Secondary outcomes:
measure: Ratio of Correct volemic classification of hyponatremia when Changes in Serum creatinine were used.
timeFrame: 4 months
measure: Diagnostic Accuracy of Urine sodium for volemic classification of hyponatremia
timeFrame: 4 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Servicio de Endocrinología y Nutrición. Hospital Clínico San Carlos
Study officials:
affiliation: Hospital San Carlos, Madrid
name: Isabelle Runkle, MDPhD
role: STUDY_DIRECTOR
affiliation: Hospital San Carlos, Madrid
name: Jorge G Ruiz, MD
role: PRINCIPAL_INVESTIGATOR
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