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

Sponsor

Hospital San Carlos, Madrid (Other)

Overall Status

Completed

CT.gov ID

NCT04744987

Collaborator

(none)

122

Enrollment

Location

Actual Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyponatremia Hypovolemia SIADH

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 Design

Study Type:

Observational

Actual Enrollment :

122 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jul 30, 2019

Actual Primary Completion Date :

May 30, 2020

Actual Study Completion Date :

Oct 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Hypovolemic hyponatremia Patients with any cause of hypovolemic hyponatremia were included.
Euvolemic hyponatremia Only patients with euvolemic hyponatremia secondary to Syndrome of inappropriate antidiuresis were included.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.