Efficacy and Safety of Bolus Comparing With Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia.

Hyponatremia Clinical Trial

Official title:

Efficacy and Safety of Intermittent Bolus Comparing With Traditional Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia at Rajavithi Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04561531
• Other study ID #: 148/2563
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: August 2020
• Source: Rajavithi Hospital
• Contact: Orakan Lanwong
• Phone: 0803625252
• Email: orakanpor[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare between intermittent bolus and traditional continuous drip of 3%NaCl in patients with severe symptomatic hyponatremia in Rajavithi Hospital.

Description:

Background: Hyponatremia is the most common electrolyte imbalance in clinical practice, associated with increased mortality and length of stay. In 2014,European guideline have recommended promp infusion of 3%NaCl 150 ml in 20 minutes to raise plasma Na to 5 mmol/L and improve symptoms. The recommendation was the result of studies with small numbers of patients, and expert opinions. Methods: A single center opened-label randomized controlled-trial,we will randomly assign 40 patients with severe symptomatic hyponatremia (plasmaNa<125mmol/L) in Rajavithi Hospital into two groups: First group receive intermittent bolus of 3%NaCl 150 ml in 30 minutes and follow plasma sodium until achieve target of goal plasma sodium = 5 mmol/L in 6 hours (no more than 12 mmol/L in 24 hr and 18 mmol/L in 48 hr),another receive traditional continuous drip of 3%NaCl start with rate = 1ml/kg/hr and follow plasma sodium every 1 hour until achieve target of plasma sodium 5 mmol/L in 6 hours .The primary end point is change in plasma sodium in 6 hours and improvement of glasglow coma scale.The secondary end points are change in plasma sodium in 24,48 hours,overcorrection rate in 24 and 48 hours ,ODS rate ,hospitality days and mortality rate.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients in Rajavithi Hospital
• Age from 18 years
• Plasma Na < 125 mmol/l with glucose-corrected
• Severe symptomatic hyponatremia (Vomitting ,Coma ,Somnolence)

Exclusion Criteria:

• Systolic BP < 90 mmHg Or MAP< 70 mmHg
• Pregnancy or Lactation
• Congestive Heart Failure or Volume overload
• Lung congestionfrom CXR
• Chronic renal failure patients with edema
• Cirrhosis patients with edema
• Patients with coronary artery disease
• Patients with brain injuries
• Deny consent

Related Conditions & MeSH terms

• Demyelinating Diseases
• Hyponatremia
• Osmotic Demyelination Syndrome

Intervention

Other:
• 3%NaCl
Intervention is infusion of 3%NaCl which is defined in arms of experiment.

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (13)

Adrogué HJ, Madias NE. Hyponatremia. N Engl J Med. 2000 May 25;342(21):1581-9. Review. — View Citation

Ayus JC, Krothapalli RK, Arieff AI. Treatment of symptomatic hyponatremia and its relation to brain damage. A prospective study. N Engl J Med. 1987 Nov 5;317(19):1190-5. Review. — View Citation

Ball SG, Iqbal Z. Diagnosis and treatment of hyponatraemia. Best Pract Res Clin Endocrinol Metab. 2016 Mar;30(2):161-73. doi: 10.1016/j.beem.2015.12.001. Epub 2015 Dec 30. Review. — View Citation

Garrahy A, Dineen R, Hannon AM, Cuesta M, Tormey W, Sherlock M, Thompson CJ. Continuous Versus Bolus Infusion of Hypertonic Saline in the Treatment of Symptomatic Hyponatremia Caused by SIAD. J Clin Endocrinol Metab. 2019 Sep 1;104(9):3595-3602. doi: 10.1 — View Citation

George JC, Zafar W, Bucaloiu ID, Chang AR. Risk Factors and Outcomes of Rapid Correction of Severe Hyponatremia. Clin J Am Soc Nephrol. 2018 Jul 6;13(7):984-992. doi: 10.2215/CJN.13061117. Epub 2018 Jun 5. — View Citation

Hoorn EJ, Zietse R. Diagnosis and Treatment of Hyponatremia: Compilation of the Guidelines. J Am Soc Nephrol. 2017 May;28(5):1340-1349. doi: 10.1681/ASN.2016101139. Epub 2017 Feb 7. Review. — View Citation

King JD, Rosner MH. Osmotic demyelination syndrome. Am J Med Sci. 2010 Jun;339(6):561-7. doi: 10.1097/MAJ.0b013e3181d3cd78. Review. — View Citation

Koenig MA, Bryan M, Lewin JL 3rd, Mirski MA, Geocadin RG, Stevens RD. Reversal of transtentorial herniation with hypertonic saline. Neurology. 2008 Mar 25;70(13):1023-9. doi: 10.1212/01.wnl.0000304042.05557.60. Epub 2008 Feb 13. — View Citation

Lee A, Jo YH, Kim K, Ahn S, Oh YK, Lee H, Shin J, Chin HJ, Na KY, Lee JB, Baek SH, Kim S. Efficacy and safety of rapid intermittent correction compared with slow continuous correction with hypertonic saline in patients with moderately severe or severe sym — View Citation

Mohmand HK, Issa D, Ahmad Z, Cappuccio JD, Kouides RW, Sterns RH. Hypertonic saline for hyponatremia: risk of inadvertent overcorrection. Clin J Am Soc Nephrol. 2007 Nov;2(6):1110-7. Epub 2007 Oct 3. — View Citation

Owen BE, Rogers IR, Hoffman MD, Stuempfle KJ, Lewis D, Fogard K, Verbalis JG, Hew-Butler T. Efficacy of oral versus intravenous hypertonic saline in runners with hyponatremia. J Sci Med Sport. 2014 Sep;17(5):457-62. doi: 10.1016/j.jsams.2013.09.001. Epub — View Citation

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 guidel — View Citation

Sterns RH, Nigwekar SU, Hix JK. The treatment of hyponatremia. Semin Nephrol. 2009 May;29(3):282-99. doi: 10.1016/j.semnephrol.2009.03.002. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma sodium and glasglow coma scale(GCS)	Change in plasma sodium and level of consciousness (GCS)	6 hours
Secondary	Plasma sodium and glasglow coma scale(GCS)	Change in plasma sodium and level of consciousness (GCS)	24 and 48 hours
Secondary	overcorrection rate	rate of overcorrection which defined as change in plasma sodium over 12 mmol/L in 24 hr and 18 mmol/L in 48 hr	24 and 48 hours
Secondary	ODS rate	rate of osmotic demyelinating syndrome	in 7 days
Secondary	hospitality days	hospitality days	until discharge
Secondary	mortality rate	mortality rate	in 30 days

External Links

•   14. Lambeck J, Hieber M, Dreßing A, Niesen WD. Central pontine myelinolysis and osmotic demyelination syndrome. Dtsch Arztebl Int. 2019; 116: 600-6.
•   7. Mohamed OH, Abdallah N. Prevention and treatment of the osmotic demyelination syndrome: JSM Brain Sci 2016; 1: 1004.