HyponatremiaNCT04744987
Changes in Serum Creatinine Levels Can Help Distinguish Hypovolemic From Euvolemic Hyponatremia
An observational study of Hyponatremia and Hypovolemia, run by Hospital San Carlos, Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia, Hypovolemia, SIADH
- How many people
- 122 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jul 2019to 30 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Endocrinología y Nutrición. Hospital Clínico San Carlos
Madrid, 28040
About this study
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.
Read the 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.
- Conditions
- Hyponatremia, Hypovolemia, SIADH
- Keywords
- hyponatremia diagnosis, serum creatinine;, hypovolemic hyponatremia, euvolemic hyponatremia, SIAD
- Medical subject headings
- Hyponatremia, Hypovolemia, Inappropriate ADH Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (2)
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.
Measured: 4 months
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start30 Jul 2019
- Primary completion30 May 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Gabriel Ruiz Sánchez, Hospital San Carlos, Madrid
- Investigators
- Isabelle Runkle, MDPhD, Study director, Hospital San Carlos, MadridJorge G Ruiz, MD, Principal investigator, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744987
- Sponsor's protocol ID
- creatinine-hyponatremia
- Status last verified
- Aug 2022
- First submitted
- 4 Feb 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data supporting the findings of this study will be available to be requested to the investigators.
Publications
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.
PubMed 24569125Verbalis JG, Goldsmith SR, Greenberg A, Korzelius C, Schrier RW, Sterns RH, Thompson CJ. Diagnosis, evaluation, and treatment of hyponatremia: expert panel recommendations. Am J Med. 2013 Oct;126(10 Suppl 1):S1-42. doi: 10.1016/j.amjmed.2013.07.006.
PubMed 24074529Adrogue HJ, Madias NE. Hyponatremia. N Engl J Med. 2000 May 25;342(21):1581-9. doi: 10.1056/NEJM200005253422107. No abstract available.
PubMed 10824078Chung HM, Kluge R, Schrier RW, Anderson RJ. Clinical assessment of extracellular fluid volume in hyponatremia. Am J Med. 1987 Nov;83(5):905-8. doi: 10.1016/0002-9343(87)90649-8.
PubMed 3674097Musch W, Thimpont J, Vandervelde D, Verhaeverbeke I, Berghmans T, Decaux G. Combined fractional excretion of sodium and urea better predicts response to saline in hyponatremia than do usual clinical and biochemical parameters. Am J Med. 1995 Oct;99(4):348-55. doi: 10.1016/s0002-9343(99)80180-6.
PubMed 7573088Fenske W, Stork S, Koschker AC, Blechschmidt A, Lorenz D, Wortmann S, Allolio B. Value of fractional uric acid excretion in differential diagnosis of hyponatremic patients on diuretics. J Clin Endocrinol Metab. 2008 Aug;93(8):2991-7. doi: 10.1210/jc.2008-0330. Epub 2008 May 13.
PubMed 18477658Musch W, Decaux G. Utility and limitations of biochemical parameters in the evaluation of hyponatremia in the elderly. Int Urol Nephrol. 2001;32(3):475-93. doi: 10.1023/a:1017586004688.
PubMed 11583374Musch W, Decaux G. Treating the syndrome of inappropriate ADH secretion with isotonic saline. QJM. 1998 Nov;91(11):749-53. doi: 10.1093/qjmed/91.11.749.
PubMed 10024938Tzoulis P, Runkle-De la Vega I. The Diagnostic Approach to the Patient with Hyponatremia: Are the Correct Investigations Being Done? Front Horm Res. 2019;52:190-199. doi: 10.1159/000493248. Epub 2019 Jan 15.
PubMed 32097921Cui H, He G, Yang S, Lv Y, Jiang Z, Gang X, Wang G. Inappropriate Antidiuretic Hormone Secretion and Cerebral Salt-Wasting Syndromes in Neurological Patients. Front Neurosci. 2019 Nov 8;13:1170. doi: 10.3389/fnins.2019.01170. eCollection 2019.
PubMed 31780881Narins RG, Jones ER, Stom MC, Rudnick MR, Bastl CP. Diagnostic strategies in disorders of fluid, electrolyte and acid-base homeostasis. Am J Med. 1982 Mar;72(3):496-520. doi: 10.1016/0002-9343(82)90521-6.
PubMed 7036739Cook DJ, Simel DL. The Rational Clinical Examination. Does this patient have abnormal central venous pressure? JAMA. 1996 Feb 28;275(8):630-4. No abstract available.
PubMed 8594245Avcil M, Kapci M, Dagli B, Omurlu IK, Ozluer E, Karaman K, Yilmaz A, Zencir C. Comparision of ultrasound-based methods of jugular vein and inferior vena cava for estimating central venous pressure. Int J Clin Exp Med. 2015 Jul 15;8(7):10586-94. eCollection 2015.
PubMed 26379848Nik Muhamad NA, Safferi RS, Robertson CE. Internal Jugular Vein Height and Inferior Vena Cava Diameter Measurement using Ultrasound to Determine Central Venous Pressure: A Correlation Study. Med J Malaysia. 2015 Apr;70(2):63-6.
PubMed 26162379Rizkallah J, Jack M, Saeed M, Shafer LA, Vo M, Tam J. Non-invasive bedside assessment of central venous pressure: scanning into the future. PLoS One. 2014 Oct 3;9(10):e109215. doi: 10.1371/journal.pone.0109215. eCollection 2014.
PubMed 25279995
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Serum Creatinine Levels Can Help Distinguish Hypovolemic From Euvolemic Hyponatremia
- ClinicalTrials.gov ID
- NCT04744987
- Acronym / sponsor ID
- creatinine-hyponatremia
- Conditions
- Hyponatremia, Hypovolemia, SIADH
- Keywords
- hyponatremia diagnosis, serum creatinine;, hypovolemic hyponatremia, euvolemic hyponatremia, SIAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Ratio of Correct volemic classification of hyponatremia when Changes in Serum creatinine were used.
Time frame: 4 months
Diagnostic Accuracy of Urine sodium for volemic classification of hyponatremia
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Background: PubMed 24569125Spasovski 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.
- Background: PubMed 24074529Verbalis JG, Goldsmith SR, Greenberg A, Korzelius C, Schrier RW, Sterns RH, Thompson CJ. Diagnosis, evaluation, and treatment of hyponatremia: expert panel recommendations. Am J Med. 2013 Oct;126(10 Suppl 1):S1-42. doi: 10.1016/j.amjmed.2013.07.006.
- Background: PubMed 10824078Adrogue HJ, Madias NE. Hyponatremia. N Engl J Med. 2000 May 25;342(21):1581-9. doi: 10.1056/NEJM200005253422107. No abstract available.
- Background: PubMed 3674097Chung HM, Kluge R, Schrier RW, Anderson RJ. Clinical assessment of extracellular fluid volume in hyponatremia. Am J Med. 1987 Nov;83(5):905-8. doi: 10.1016/0002-9343(87)90649-8.
- Background: PubMed 7573088Musch W, Thimpont J, Vandervelde D, Verhaeverbeke I, Berghmans T, Decaux G. Combined fractional excretion of sodium and urea better predicts response to saline in hyponatremia than do usual clinical and biochemical parameters. Am J Med. 1995 Oct;99(4):348-55. doi: 10.1016/s0002-9343(99)80180-6.
- Background: PubMed 18477658Fenske W, Stork S, Koschker AC, Blechschmidt A, Lorenz D, Wortmann S, Allolio B. Value of fractional uric acid excretion in differential diagnosis of hyponatremic patients on diuretics. J Clin Endocrinol Metab. 2008 Aug;93(8):2991-7. doi: 10.1210/jc.2008-0330. Epub 2008 May 13.
- Background: PubMed 11583374Musch W, Decaux G. Utility and limitations of biochemical parameters in the evaluation of hyponatremia in the elderly. Int Urol Nephrol. 2001;32(3):475-93. doi: 10.1023/a:1017586004688.
- Background: PubMed 10024938Musch W, Decaux G. Treating the syndrome of inappropriate ADH secretion with isotonic saline. QJM. 1998 Nov;91(11):749-53. doi: 10.1093/qjmed/91.11.749.
- Background: PubMed 32097921Tzoulis P, Runkle-De la Vega I. The Diagnostic Approach to the Patient with Hyponatremia: Are the Correct Investigations Being Done? Front Horm Res. 2019;52:190-199. doi: 10.1159/000493248. Epub 2019 Jan 15.
- Background: PubMed 31780881Cui H, He G, Yang S, Lv Y, Jiang Z, Gang X, Wang G. Inappropriate Antidiuretic Hormone Secretion and Cerebral Salt-Wasting Syndromes in Neurological Patients. Front Neurosci. 2019 Nov 8;13:1170. doi: 10.3389/fnins.2019.01170. eCollection 2019.
- Background: PubMed 7036739Narins RG, Jones ER, Stom MC, Rudnick MR, Bastl CP. Diagnostic strategies in disorders of fluid, electrolyte and acid-base homeostasis. Am J Med. 1982 Mar;72(3):496-520. doi: 10.1016/0002-9343(82)90521-6.
- Background: PubMed 8594245Cook DJ, Simel DL. The Rational Clinical Examination. Does this patient have abnormal central venous pressure? JAMA. 1996 Feb 28;275(8):630-4. No abstract available.
- Individual participant dataSharing planned: Yes. The data supporting the findings of this study will be available to be requested to the investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Runkle, MDPhD study director
Hospital San Carlos, Madrid
Jorge G Ruiz, MD principal investigator
Hospital San Carlos, Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia and Hypovolemia, run by Hospital San Carlos, Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of the changes in serum creatinine for volemic classification of hyponatremia (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04744987, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.