Clinical trial NCT06061783: Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water
Official title: Correction of Hypernatremia by Intravenous Hypotonic Solution Compared to Enteral Water, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypernatremia
Keywords: Hypernatremia
intravenous hypotonic solution
enteral water
Lead sponsor: Hospital Civil de Guadalajara
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open Label randomized trial
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients with hypernatremia (serum sodium\>145mEq/L).

Exclusion Criteria:

* Age below 18 years
* Pregnant, on dialysis
* Unwilling to participate or without informed consent.

Primary outcomes:
measure: The efficiency of intravenous hypotonic solution for the correction of hypernatremia compared with enteral water.
timeFrame: every 12 hours during the first 48hrs of treatment and then every 24 hours for the first 5 days of the study.
Secondary outcomes:
measure: mortality
timeFrame: the first 5 days of the study
measure: renal function
timeFrame: the first 5 days of the study
measure: volume overload
timeFrame: the first 5 days of the study
measure: neurological alterations
timeFrame: the first 5 days of the study
Other outcomes:
measure: hyperglycemia, glucose >180mg/dL
timeFrame: the first 5 days of the study
Locations:
Study officials:
affiliation: HCG
name: Jonathan Samuel Chavez Iñiguez
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lindner 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.
citation: Darmon 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.
citation: O'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.
citation: Chand 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.
citation: Thongprayoon 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.
citation: Robertson 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.
citation: Fenske 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.
citation: Timper 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.
citation: Bolat 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.
citation: Alshayeb 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.
citation: Borra SI, Beredo R, Kleinfeld M. Hypernatremia in the aging: causes, manifestations, and outcome. J Natl Med Assoc. 1995 Mar;87(3):220-4.
citation: Darmon 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.
citation: Andersen 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.
citation: Sands 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.
citation: Gordon CE, Vantzelfde S, Francis JM. Acetazolamide in Lithium-Induced Nephrogenic Diabetes Insipidus. N Engl J Med. 2016 Nov 17;375(20):2008-2009. doi: 10.1056/NEJMc1609483. No abstract available.
citation: Chauhan K, Pattharanitima P, Patel N, Duffy A, Saha A, Chaudhary K, Debnath N, Van Vleck T, Chan L, Nadkarni GN, Coca SG. Rate of Correction of Hypernatremia and Health Outcomes in Critically Ill Patients. Clin J Am Soc Nephrol. 2019 May 7;14(5):656-663. doi: 10.2215/CJN.10640918. Epub 2019 Apr 4.
citation: Muhsin SA, Mount DB. Diagnosis and treatment of hypernatremia. Best Pract Res Clin Endocrinol Metab. 2016 Mar;30(2):189-203. doi: 10.1016/j.beem.2016.02.014. Epub 2016 Mar 4.
citation: Lindner G, Schwarz C, Kneidinger N, Kramer L, Oberbauer R, Druml W. Can we really predict the change in serum sodium levels? An analysis of currently proposed formulae in hypernatraemic patients. Nephrol Dial Transplant. 2008 Nov;23(11):3501-8. doi: 10.1093/ndt/gfn476. Epub 2008 Aug 22.
citation: de Vos EAJ, van der Voort PHJ. ICU acquired hypernatremia treated by enteral free water - A retrospective cohort study. J Crit Care. 2021 Apr;62:72-75. doi: 10.1016/j.jcrc.2020.11.013. Epub 2020 Nov 21.
citation: McCowen KC, Malhotra A, Bistrian BR. Stress-induced hyperglycemia. Crit Care Clin. 2001 Jan;17(1):107-24. doi: 10.1016/s0749-0704(05)70154-8.
citation: Popas RH. Treatment of hypernatremia in adults. In: Emmett M, Forman JP, eds. Wolters Kluwer; 2020. Available at: https://www.uptodate.com
citation: Sarahian S, Pouria MM, Ing TS, Sam R. Hypervolemic hypernatremia is the most common type of hypernatremia in the intensive care unit. Int Urol Nephrol. 2015 Nov;47(11):1817-21. doi: 10.1007/s11255-015-1103-0. Epub 2015 Sep 16.
citation: Nur S, Khan Y, Nur S, Boroujerdi H. Hypernatremia: correction rate and hemodialysis. Case Rep Med. 2014;2014:736073. doi: 10.1155/2014/736073. Epub 2014 Nov 9.
citation: Ma F, Bai M, Li Y, Yu Y, Liu Y, Zhou M, Li L, Jing R, Zhao L, He L, Li R, Huang C, Wang H, Sun S. Continuous Venovenous Hemofiltration (CVVH) Versus Conventional Treatment for Acute Severe Hypernatremia in Critically Ill Patients: A Retrospective Study. Shock. 2015 Nov;44(5):445-51. doi: 10.1097/SHK.0000000000000443.