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

Hyponatremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04744987
• Other study ID #: creatinine-hyponatremia
• Status: Completed
• Start date: July 30, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: August 2022
• Source: Hospital San Carlos, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: October 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyponatremia
• Hypovolemia
• SIADH

Locations

Country	Name	City	State
Spain	Servicio de Endocrinología y Nutrición. Hospital Clínico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (19)

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Ruiz-Sánchez JG, Meneses D, Álvarez-Escolá C, Cuesta M, Calle-Pascual AL, Runkle I. The Effect of the Dose of Isotonic Saline on the Correction of Serum Sodium in the Treatment of Hypovolemic Hyponatremia. J Clin Med. 2020 Nov 5;9(11). pii: E3567. doi: 10.3390/jcm9113567. — View Citation

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Spasovski G, Vanholder R, Allolio B, Annane D, Ball S, Bichet D, Decaux G, Fenske W, Hoorn EJ, Ichai C, Joannidis M, Soupart A, Zietse R, Haller M, van der Veer S, Van Biesen W, Nagler E; Hyponatraemia Guideline Development Group. Clinical practice guideline on diagnosis and treatment of hyponatraemia. Eur J Endocrinol. 2014 Feb 25;170(3):G1-47. doi: 10.1530/EJE-13-1020. Print 2014 Mar. Erratum in: Eur J Endocrinol. 2014 Jul;171(1):X1. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Accuracy of the changes in serum creatinine for volemic classification of hyponatremia	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.	4 months
Secondary	Ratio of Correct volemic classification of hyponatremia when Changes in Serum creatinine were used.	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.	4 months
Secondary	Diagnostic Accuracy of Urine sodium for volemic classification of hyponatremia	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.	4 months