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
To compare between intermittent bolus and traditional continuous drip of 3%NaCl in patients with severe symptomatic hyponatremia in Rajavithi Hospital.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06037928 -
Plasma Sodium and Sodium Administration in the ICU
|
||
| Terminated |
NCT02012959 -
Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
|
Phase 3 | |
| Recruiting |
NCT02936167 -
Comparison of Ringer Lactate and Isotonic Acetate Solution as Perioperative Maintenance Fluid for Children
|
N/A | |
| Completed |
NCT00621348 -
Maintenance Intravenous Fluids in Children
|
Phase 3 | |
| Terminated |
NCT03703713 -
Colloid Osmotic Pressure and Osmolality in Hyponatremia
|
||
| Completed |
NCT02926989 -
Intravenous Fluids in Hospitalised Children
|
Phase 4 | |
| Terminated |
NCT02959411 -
Tolvaptan for Advanced or Refractory Heart Failure
|
Phase 4 | |
| Completed |
NCT02573077 -
An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy
|
||
| Withdrawn |
NCT02667977 -
Reexamining Hypotonic Intravenous Fluid Use
|
N/A | |
| Terminated |
NCT01708811 -
Hyponatremia and Myometrium Contractility. An Invitro Study
|
N/A | |
| Withdrawn |
NCT01326429 -
Frequency and Origin of Dysnatremias in the Emergency Department
|
N/A | |
| Completed |
NCT01456533 -
Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients
|
N/A | |
| Terminated |
NCT01227512 -
Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia
|
Phase 3 | |
| Recruiting |
NCT06013800 -
Hyponatremia Volume Status Analysis by Point-of-care Ultrasound
|
||
| Terminated |
NCT04020926 -
Impact of Hyponatremia on Muscle Strength, Gait and Cognitive Function
|
||
| Completed |
NCT02545101 -
An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH
|
N/A | |
| Withdrawn |
NCT02442674 -
A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia
|
Phase 3 | |
| Terminated |
NCT02215148 -
Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients
|
N/A | |
| Recruiting |
NCT01748331 -
The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia
|
N/A | |
| Not yet recruiting |
NCT01716611 -
Tolvaptan for Hyponatremia in Cirrhotic Patients With Ascites
|
Phase 4 |