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

NCT04744987 | Completed DMC

• 1 other identifier: creatinine-hyponatremia
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyponatremia; Hypovolemia; SIADH

Keywords

hyponatremia diagnosis; serum creatinine;; hypovolemic hyponatremia; euvolemic hyponatremia; SIAD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  4 months

• Diagnostic Accuracy of Urine sodium for volemic classification of hyponatremia

  4 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (1)

Servicio de Endocrinología y Nutrición. Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Related Publications (19)

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MeSH Terms

Conditions

Hyponatremia; Hypovolemia; Inappropriate ADH Syndrome

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Isabelle Runkle, MDPhD

  Hospital San Carlos, Madrid

  STUDY DIRECTOR

• Jorge G Ruiz, MD

  Hospital San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 9, 2021
• Study Start: July 30, 2019
• Primary Completion: May 30, 2020
• Study Completion: October 30, 2020
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: starting 12 months after publication to 18 months after publication
• Access Criteria: IPD might be requested only by e-mail. IPD might be shared only with medical investigators with a corroborated affiliation and attached to an official research group. IPD would be shared only for an exploratory analysis in order to confirm the results of the current study. IPD sharing request must include reasons for the petition. No new results, research, or publications can be made with the shared IPD. IPD sharing requests will be reviewed and approved by all authors to decide whether to submit.

Locations

ES (1)