Changes in Serum Creatinine Levels Can Help Distinguish Hypovolemic From Euvolemic Hyponatremia

Completed

• Conditions: Hyponatremia; SIADH; Hypovolemia

• Registration Number: NCT04744987
• Lead Sponsor: Hospital San Carlos, Madrid

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.

Study Timeline

• Study Start: 2019-07-30
• Primary Completion: 2020-05-30
• Study Completion: 2020-10-30
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-09
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy of the changes in serum creatinine for volemic classification of hyponatremia	4 months	Area under the curve from the Receiver operating characteristic curve analysis were calculated for the changes in serum creatinine. Probabilities of each evaluated tool (arithmetic and percentual change in serum creatinine) to correctly classified the volemic status of the hyponatremic patients were calculated.

Secondary Outcome Measures

Name	Time	Method
Ratio of Correct volemic classification of hyponatremia when Changes in Serum creatinine were used.	4 months	Ratio of patients who were correctly classified according to volemic status with different cut-off points obtained from the Receiver operating characteristic curve analyzes. Sensitivity, Specificity, Positive and Negative predictive values were also calculated.
Diagnostic Accuracy of Urine sodium for volemic classification of hyponatremia	4 months	Area under the curve from the Receiver operating characteristic curve analysis were calculated for the urine sodium y patients with hyponatremia. Sensitivity, specificity, and Positive and Negative predictive values were calculated.

Trial Locations

Locations (1)

Servicio de Endocrinología y Nutrición. Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain