Continuous Venovenous Hemofiltration Versus Conventional Treatment for Acute Severe Hypernatremia

Study Overview
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Brief Summary
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The patients with severe hypernatremia who received conventional treatment are often undertreated. Continuous venovenous hemofiltration (CVVH) can effectively remove solute or water from circulation system. Several case reports demonstrated that CVVH could effectively decrease serum sodium concentration of the patients with severe hypernatremia. The use of CVVH for acute severe hypernatremia in critically ill patients could improve patient survival by effectively decreasing the serum sodium concentration to a normal level.

Detailed Description
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Date collection: Demographic (gender, age, race, weight, history of drug allergy, complicating diseases, drug combination and combination therapy) CVVH treatment (time, blood vessel, blood flow, replacement fluid flow, the type and dose of anticoagulant, limited to the test group) Vital signs (blood pressure, heart rate, respiratory frequency, body temperature) Severity of disease General treatment (Vasoactive drugs, mechanical ventilation, diuretic, steroid hormones) 6.24 hours input 7.24 hour output 8.Daily sodium intake 9.Adverse events were confirmed 10.Laboratory date: Routine blood test Blood biochemical Blood gas analysis Blood electrolyte Plasma osmotic pressure Urine osmotic pressure Plasma osmotic pressure Urinary electrolyte excretion fraction

Official Title
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To Effect and Safety of Continuous Venovenous Hemofiltration (CVVH) Versus Conventional Treatment for Acute Severe Hypernatremia in Critical Ill Patients: A Randomized Clinical Trial

Conditions
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Hypernatremia, Critically Ill

Intervention / Treatment
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* Procedure: continuous venovenous hemofiltration
* Drug: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥18 years Acute severe hypernatremia(increasing of serum sodium levels from normal levels to ≥160 mmol/L within 48 hours) ICU patients Exclusion Criteria: Hypovolemic hypernatremia fractional excretion of sodium <0.5% and Urea/Creatinine >40 receiving diuretics: Urea/Creatinine >40, No edema. Acute kidney injure network III End-stage renal disease Hemodialysis or peritoneal dialysis K+>6.5mmol/L The drug is difficult to treat hyperkalemia Hydrogen ion concentration<7.2 The drug is difficult to treat metabolic acidosis Acute pulmonary edema Systolic blood pressure <90 mmHg vasoactive drugs in the treatment of systolic blood pressure less than 90 mmHg The heparin or low molecular allergic patients HIV positive patients Pregnant women or lactational pregnancy women Suspected tuberculosis patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: continuous venovenous hemofiltration<br>CVVH was mainly determined by the differences of sodium concentration between serum and replacement fluid. The rate of decline serum sodium could be real-time adjusted using different-sodium-concentration replacement fluid according to the updated serum sodium concentration. | Procedure: continuous venovenous hemofiltration<br>* If the serum sodium concentration >150mmol/L, When filter occurred clotting, replace the filter to CVVH treatment<br>* Other names: continuous renal replacement therapy;|
| Active Comparator: Control group<br>Treatment of hypernatremia is correction of water deficit. | Drug: Control group<br>* If the serum sodium concentration ≤150mmol/L, When filter occurred clotting, as the end of treatment.<br>* Other names: standard treatments;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day all cause mortality |  | 7days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Coma score changes | On the third day of the Glasgow Coma score minus baseline of the Glasgow Coma score | 3 days | 
| Sequential Organ Failure Assessment score changes | On the third day of the Sequential Organ Failure Assessment score minus baseline of the Sequential Organ Failure Assessment score | 3 days | 
| Acute Physiology and Chronic Health Evaluation II score changes | On the third day of the Acute Physiology and Chronic Health Evaluation II score minus baseline of the Acute Physiology and Chronic Health Evaluation II score | 3 days | 
| The average reduce rate of serum sodium | The average reduce rate of serum sodium was calculated as following: (serum sodium concentration before treatment (mmol/L) - serum sodium concentration after treatment (mmol/L)) / time after treatment (hours) | 3 days | 
| 24-hour correction of hypernatremia | Twenty-four-hour correction of hypernatremia was defined as the reduction of serum sodium concentration to ≤145 mmol/L within 24 hours after the start of treatment. | 24-hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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continuous venovenous hemofiltration, conventional treatment, mortality, acute severe hypernatremia