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Completed

NCT Number: NCT04744987

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Diagnostic Accuracy of the changes in serum creatinine for volemic classification of hyponatremia

    Time frame: 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 outcomes

  1. Ratio of Correct volemic classification of hyponatremia when Changes in Serum creatinine were used.

    Time frame: 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.

  2. Diagnostic Accuracy of Urine sodium for volemic classification of hyponatremia

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 9, 2021
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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