HypernatremiaNCT06061783
Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water
A study testing Hypotonic Solution and Water Purified in people with Hypernatremia, run by Hospital Civil de Guadalajara.
Trial summary
Hypernatremia, defined as an elevation of serum sodium >145 mEq/L, is one of the most common electrolyte disturbances in hospitalized patients and intensive care units. In this study, the investigator aims, for the first time, to compare two strategies used for the correction of hypernatremia, using intravenous… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypernatremia
- What is being tested?
- Hypotonic Solution and Water Purified
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2023to 30 Sep 2024
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients with hypernatremia (serum sodium>145mEq/L).
Who cannot join
- Age below 18 years
- Pregnant, on dialysis
- Unwilling to participate or without informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water, Randomized Clinical Trial
Hypernatremia, defined as an elevation of serum sodium >145 mEq/L, is one of the most common electrolyte disturbances in hospitalized patients and intensive care units.
In this study, the investigator aims, for the first time, to compare two strategies used for the correction of hypernatremia, using intravenous hypotonic solution compared to naso- or orogastric tube enteral water.
Read the detailed description
Hypernatremia, defined as an elevation of serum sodium >145 mEq/L, is one of the most common electrolyte disturbances in hospitalized patients and intensive care units, increasing mortality. Currently, the most effective correction strategy for hypernatremia (intravenous hypotonic solution compared to enteral water) is still a matter of debate due to a lack of evidence and clinical trials.
This study aims to determine whether the administration of intravenous hypotonic solution is more effective in the correction of hypernatremia compared to enteral water by naso- or orogastric tube. Therefore, the investigator proposes the first randomized clinical trial, which compares two strategies used for the correction of hypernatremia, with this we will determine which of the two is more effective, and we will also compare the speed of correction, renal function during hospitalization with serum creatinine and we will evaluate its safety.
- Conditions
- Hypernatremia
- Being tested
- Hypotonic Solution, Water Purified
- Keywords
- Hypernatremia, intravenous hypotonic solution, enteral water
- Medical subject headings
- Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypotonic SolutionDrug
Intravenous administration of 5% glucose solution 1,200ml every 8 hours for a total of 3,600ml per day.
If hyperglycemia is present, it will be glucose solution 5% 500ml + injectable water 500ml intravenous every 8 hours for a total of 3,600ml daily.
Water PurifiedDrug
administration of bottled water through the nasogastric or orogastric tube at a dose of 150 ml/hour for a total of 3,600 ml per day.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous hypotonic solution | Active comparator | In this group, the administration will be according to the presence of basal hyperglycemia on the day before the assignment (>180mg/dL).
If hyperglycemia is present, it will be glucose solution 5% 500ml + injectable water 500ml intravenous every 8 hours for a total of 3,600ml daily.
If there is no hyperglycemia, it will be 5% glucose solution 1,200ml every 8 hours for a total of 3,600ml per day. Receives: Drug: Hypotonic Solution |
| Enteral water | Placebo comparator | This group will receive bottled water through the nasogastric or orogastric tube at a dose of 150 ml/hour for a total of 3,600 ml per day. Receives: Drug: Water Purified |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficiency of intravenous hypotonic solution for the correction of hypernatremia compared with enteral water.
Correction of hypernatremia is <145mEq/L serum sodium
Measured: every 12 hours during the first 48hrs of treatment and then every 24 hours for the first 5 days of the study.
Secondary outcomes (4)
mortality
Measured: the first 5 days of the study
renal function
serum creatinine
Measured: the first 5 days of the study
volume overload
volume overload determined by accumulated water balance in milliliters
Measured: the first 5 days of the study
neurological alterations
neurological disorders defined as the presence of altered state of consciousness, seizures and/or cerebral edema
Measured: the first 5 days of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start30 Nov 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for HypernatremiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open Label randomized trial
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Samuel Chavez Iñiguez, Hospital Civil de Guadalajara
- Investigators
- Jonathan Samuel Chavez Iñiguez, Principal investigator, HCG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061783
- Sponsor's protocol ID
- Correction of hypernatremia
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Polderman KH, Schreuder WO, Strack van Schijndel RJ, Thijs LG. Hypernatremia in the intensive care unit: an indicator of quality of care? Crit Care Med. 1999 Jun;27(6):1105-8. doi: 10.1097/00003246-199906000-00029.
PubMed 10397213Lindner G, Funk GC, Schwarz C, Kneidinger N, Kaider A, Schneeweiss B, Kramer L, Druml W. Hypernatremia in the critically ill is an independent risk factor for mortality. Am J Kidney Dis. 2007 Dec;50(6):952-7. doi: 10.1053/j.ajkd.2007.08.016.
PubMed 18037096Darmon M, Timsit JF, Francais A, Nguile-Makao M, Adrie C, Cohen Y, Garrouste-Orgeas M, Goldgran-Toledano D, Dumenil AS, Jamali S, Cheval C, Allaouchiche B, Souweine B, Azoulay E. Association between hypernatraemia acquired in the ICU and mortality: a cohort study. Nephrol Dial Transplant. 2010 Aug;25(8):2510-5. doi: 10.1093/ndt/gfq067. Epub 2010 Feb 17.
PubMed 20167570O'Donoghue SD, Dulhunty JM, Bandeshe HK, Senthuran S, Gowardman JR. Acquired hypernatraemia is an independent predictor of mortality in critically ill patients. Anaesthesia. 2009 May;64(5):514-20. doi: 10.1111/j.1365-2044.2008.05857.x.
PubMed 19413821Chand R, Chand R, Goldfarb DS. Hypernatremia in the intensive care unit. Curr Opin Nephrol Hypertens. 2022 Mar 1;31(2):199-204. doi: 10.1097/MNH.0000000000000773.
PubMed 34939612Thongprayoon C, Cheungpasitporn W, Petnak T, Ghamrawi R, Thirunavukkarasu S, Chewcharat A, Bathini T, Vallabhajosyula S, Kashani KB. The prognostic importance of serum sodium levels at hospital discharge and one-year mortality among hospitalized patients. Int J Clin Pract. 2020 Oct;74(10):e13581. doi: 10.1111/ijcp.13581. Epub 2020 Jun 23.
PubMed 32510711Robertson GL. Diabetes insipidus: Differential diagnosis and management. Best Pract Res Clin Endocrinol Metab. 2016 Mar;30(2):205-18. doi: 10.1016/j.beem.2016.02.007. Epub 2016 Feb 18.
PubMed 27156759Fenske W, Refardt J, Chifu I, Schnyder I, Winzeler B, Drummond J, Ribeiro-Oliveira A Jr, Drescher T, Bilz S, Vogt DR, Malzahn U, Kroiss M, Christ E, Henzen C, Fischli S, Tonjes A, Mueller B, Schopohl J, Flitsch J, Brabant G, Fassnacht M, Christ-Crain M. A Copeptin-Based Approach in the Diagnosis of Diabetes Insipidus. N Engl J Med. 2018 Aug 2;379(5):428-439. doi: 10.1056/NEJMoa1803760.
PubMed 30067922Timper K, Fenske W, Kuhn F, Frech N, Arici B, Rutishauser J, Kopp P, Allolio B, Stettler C, Muller B, Katan M, Christ-Crain M. Diagnostic Accuracy of Copeptin in the Differential Diagnosis of the Polyuria-polydipsia Syndrome: A Prospective Multicenter Study. J Clin Endocrinol Metab. 2015 Jun;100(6):2268-74. doi: 10.1210/jc.2014-4507. Epub 2015 Mar 13.
PubMed 25768671Bolat F, Oflaz MB, Guven AS, Ozdemir G, Alaygut D, Dogan MT, Icagasoglu FD, Cevit O, Gultekin A. What is the safe approach for neonatal hypernatremic dehydration? A retrospective study from a neonatal intensive care unit. Pediatr Emerg Care. 2013 Jul;29(7):808-13. doi: 10.1097/PEC.0b013e3182983bac.
PubMed 23823259Alshayeb HM, Showkat A, Babar F, Mangold T, Wall BM. Severe hypernatremia correction rate and mortality in hospitalized patients. Am J Med Sci. 2011 May;341(5):356-60. doi: 10.1097/MAJ.0b013e31820a3a90.
PubMed 21358313Borra SI, Beredo R, Kleinfeld M. Hypernatremia in the aging: causes, manifestations, and outcome. J Natl Med Assoc. 1995 Mar;87(3):220-4.
PubMed 7731073Darmon M, Pichon M, Schwebel C, Ruckly S, Adrie C, Haouache H, Azoulay E, Bouadma L, Clec'h C, Garrouste-Orgeas M, Souweine B, Goldgran-Toledano D, Khallel H, Argaud L, Dumenil AS, Jamali S, Allaouchiche B, Zeni F, Timsit JF. Influence of early dysnatremia correction on survival of critically ill patients. Shock. 2014 May;41(5):394-9. doi: 10.1097/SHK.0000000000000135.
PubMed 24667611Andersen LJ, Andersen JL, Pump B, Bie P. Natriuresis induced by mild hypernatremia in humans. Am J Physiol Regul Integr Comp Physiol. 2002 Jun;282(6):R1754-61. doi: 10.1152/ajpregu.00732.2001.
PubMed 12010758Sands JM, Klein JD. Physiological insights into novel therapies for nephrogenic diabetes insipidus. Am J Physiol Renal Physiol. 2016 Dec 1;311(6):F1149-F1152. doi: 10.1152/ajprenal.00418.2016. Epub 2016 Aug 17.
PubMed 27534996
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06061783
- Acronym / sponsor ID
- Correction of hypernatremia
- Conditions
- Hypernatremia
- Keywords
- Hypernatremia, intravenous hypotonic solution, enteral water
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Study start
- 30 Nov 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 29 Sep 2023 (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.
Hypernatremia, defined as an elevation of serum sodium >145 mEq/L, is one of the most common electrolyte disturbances in hospitalized patients and intensive care units.
In this study, the investigator aims, for the first time, to compare two strategies used for the correction of hypernatremia, using intravenous hypotonic solution compared to naso- or orogastric tube enteral water.
Detailed description
Hypernatremia, defined as an elevation of serum sodium >145 mEq/L, is one of the most common electrolyte disturbances in hospitalized patients and intensive care units, increasing mortality. Currently, the most effective correction strategy for hypernatremia (intravenous hypotonic solution compared to enteral water) is still a matter of debate due to a lack of evidence and clinical trials.
This study aims to determine whether the administration of intravenous hypotonic solution is more effective in the correction of hypernatremia compared to enteral water by naso- or orogastric tube. Therefore, the investigator proposes the first randomized clinical trial, which compares two strategies used for the correction of hypernatremia, with this we will determine which of the two is more effective, and we will also compare the speed of correction, renal function during hospitalization with serum creatinine and we will evaluate its safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open Label randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intravenous hypotonic solution | Active comparator | Drug: Hypotonic SolutionIn this group, the administration will be according to the presence of basal hyperglycemia on the day before the assignment (>180mg/dL). If hyperglycemia is present, it will be glucose solution 5% 500ml + injectable water 500ml intravenous every 8 hours for a total of 3,600ml daily. If there is no hyperglycemia, it will be 5% glucose solution 1,200ml every 8 hours for a total of 3,600ml per day. |
| Enteral water | Placebo comparator | Drug: Water PurifiedThis group will receive bottled water through the nasogastric or orogastric tube at a dose of 150 ml/hour for a total of 3,600 ml per day. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized patients with hypernatremia (serum sodium>145mEq/L).
Key exclusion criteria (3 listed)
- Age below 18 years
- Pregnant, on dialysis
- Unwilling to participate or without informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypotonic SolutionIntravenous administration of 5% glucose solution 1,200ml every 8 hours for a total of 3,600ml per day. If hyperglycemia is present, it will be glucose solution 5% 500ml + injectable water 500ml intravenous every 8 hours for a total of 3,600ml daily. | Drug | Intravenous hypotonic solution |
| Water Purifiedadministration of bottled water through the nasogastric or orogastric tube at a dose of 150 ml/hour for a total of 3,600 ml per day. | Drug | Enteral water |
Primary outcome
The efficiency of intravenous hypotonic solution for the correction of hypernatremia compared with enteral water.
Time frame: every 12 hours during the first 48hrs of treatment and then every 24 hours for the first 5 days of the study.
Correction of hypernatremia is <145mEq/L serum sodium
4 secondary outcomes
mortality
Time frame: the first 5 days of the study
renal function
Time frame: the first 5 days of the study
volume overload
Time frame: the first 5 days of the study
neurological alterations
Time frame: the first 5 days of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Background: PubMed 10397213Polderman KH, Schreuder WO, Strack van Schijndel RJ, Thijs LG. Hypernatremia in the intensive care unit: an indicator of quality of care? Crit Care Med. 1999 Jun;27(6):1105-8. doi: 10.1097/00003246-199906000-00029.
- Background: PubMed 18037096Lindner G, Funk GC, Schwarz C, Kneidinger N, Kaider A, Schneeweiss B, Kramer L, Druml W. Hypernatremia in the critically ill is an independent risk factor for mortality. Am J Kidney Dis. 2007 Dec;50(6):952-7. doi: 10.1053/j.ajkd.2007.08.016.
- Background: PubMed 20167570Darmon M, Timsit JF, Francais A, Nguile-Makao M, Adrie C, Cohen Y, Garrouste-Orgeas M, Goldgran-Toledano D, Dumenil AS, Jamali S, Cheval C, Allaouchiche B, Souweine B, Azoulay E. Association between hypernatraemia acquired in the ICU and mortality: a cohort study. Nephrol Dial Transplant. 2010 Aug;25(8):2510-5. doi: 10.1093/ndt/gfq067. Epub 2010 Feb 17.
- Background: PubMed 19413821O'Donoghue SD, Dulhunty JM, Bandeshe HK, Senthuran S, Gowardman JR. Acquired hypernatraemia is an independent predictor of mortality in critically ill patients. Anaesthesia. 2009 May;64(5):514-20. doi: 10.1111/j.1365-2044.2008.05857.x.
- Background: PubMed 34939612Chand R, Chand R, Goldfarb DS. Hypernatremia in the intensive care unit. Curr Opin Nephrol Hypertens. 2022 Mar 1;31(2):199-204. doi: 10.1097/MNH.0000000000000773.
- Background: PubMed 32510711Thongprayoon C, Cheungpasitporn W, Petnak T, Ghamrawi R, Thirunavukkarasu S, Chewcharat A, Bathini T, Vallabhajosyula S, Kashani KB. The prognostic importance of serum sodium levels at hospital discharge and one-year mortality among hospitalized patients. Int J Clin Pract. 2020 Oct;74(10):e13581. doi: 10.1111/ijcp.13581. Epub 2020 Jun 23.
- Background: PubMed 27156759Robertson GL. Diabetes insipidus: Differential diagnosis and management. Best Pract Res Clin Endocrinol Metab. 2016 Mar;30(2):205-18. doi: 10.1016/j.beem.2016.02.007. Epub 2016 Feb 18.
- Background: PubMed 30067922Fenske W, Refardt J, Chifu I, Schnyder I, Winzeler B, Drummond J, Ribeiro-Oliveira A Jr, Drescher T, Bilz S, Vogt DR, Malzahn U, Kroiss M, Christ E, Henzen C, Fischli S, Tonjes A, Mueller B, Schopohl J, Flitsch J, Brabant G, Fassnacht M, Christ-Crain M. A Copeptin-Based Approach in the Diagnosis of Diabetes Insipidus. N Engl J Med. 2018 Aug 2;379(5):428-439. doi: 10.1056/NEJMoa1803760.
- Background: PubMed 25768671Timper K, Fenske W, Kuhn F, Frech N, Arici B, Rutishauser J, Kopp P, Allolio B, Stettler C, Muller B, Katan M, Christ-Crain M. Diagnostic Accuracy of Copeptin in the Differential Diagnosis of the Polyuria-polydipsia Syndrome: A Prospective Multicenter Study. J Clin Endocrinol Metab. 2015 Jun;100(6):2268-74. doi: 10.1210/jc.2014-4507. Epub 2015 Mar 13.
- Background: PubMed 23823259Bolat F, Oflaz MB, Guven AS, Ozdemir G, Alaygut D, Dogan MT, Icagasoglu FD, Cevit O, Gultekin A. What is the safe approach for neonatal hypernatremic dehydration? A retrospective study from a neonatal intensive care unit. Pediatr Emerg Care. 2013 Jul;29(7):808-13. doi: 10.1097/PEC.0b013e3182983bac.
- Background: PubMed 21358313Alshayeb HM, Showkat A, Babar F, Mangold T, Wall BM. Severe hypernatremia correction rate and mortality in hospitalized patients. Am J Med Sci. 2011 May;341(5):356-60. doi: 10.1097/MAJ.0b013e31820a3a90.
- Background: PubMed 7731073Borra SI, Beredo R, Kleinfeld M. Hypernatremia in the aging: causes, manifestations, and outcome. J Natl Med Assoc. 1995 Mar;87(3):220-4.
- Individual participant dataSharing planned: Undecided
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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.
Jonathan Samuel Chavez Iñiguez principal investigator
HCG
Questions about this trial
What is this clinical trial studying?
A study testing Hypotonic Solution and Water Purified in people with Hypernatremia, run by Hospital Civil de Guadalajara.
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 1 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: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Samuel Chavez Iñiguez (3313299609, jonarchi_10@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficiency of intravenous hypotonic solution for the correction of hypernatremia compared with enteral water. (time frame: every 12 hours during the first 48hrs of treatment and then every 24 hours for the first 5 days of the study.). 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 NCT06061783, which also lists 25 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 29 Sep 2023.