Clinical trial NCT02449382: Continuous Venovenous Hemofiltration Versus Conventional Treatment for Acute Severe Hypernatremia
Official title: To Effect and Safety of Continuous Venovenous Hemofiltration (CVVH) Versus Conventional Treatment for Acute Severe Hypernatremia in Critical Ill Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypernatremia
Critically Ill
Keywords: continuous venovenous hemofiltration
conventional treatment
mortality
acute severe hypernatremia
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2015-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Date collection:

1. Demographic (gender, age, race, weight, history of drug allergy, complicating diseases, drug combination and combination therapy)
2. CVVH treatment (time, blood vessel, blood flow, replacement fluid flow, the type and dose of anticoagulant, limited to the test group)
3. Vital signs (blood pressure, heart rate, respiratory frequency, body temperature)
4. Severity of disease
5. 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

Eligibility criteria: Inclusion Criteria:

1. Age≥18 years
2. Acute severe hypernatremia(increasing of serum sodium levels from normal levels to ≥160 mmol/L within 48 hours)
3. ICU patients

Exclusion Criteria:

1. Hypovolemic hypernatremia fractional excretion of sodium \<0.5% and Urea/Creatinine \>40 receiving diuretics: Urea/Creatinine \>40, No edema.
2. Acute kidney injure network III
3. End-stage renal disease Hemodialysis or peritoneal dialysis
4. K+\>6.5mmol/L The drug is difficult to treat hyperkalemia
5. Hydrogen ion concentration\<7.2 The drug is difficult to treat metabolic acidosis
6. Acute pulmonary edema
7. Systolic blood pressure \<90 mmHg vasoactive drugs in the treatment of systolic blood pressure less than 90 mmHg
8. The heparin or low molecular allergic patients
9. HIV positive patients
10. Pregnant women or lactational pregnancy women
11. Suspected tuberculosis patients

Primary outcomes:
measure: 7-day all cause mortality
timeFrame: 7days
Secondary outcomes:
measure: Glasgow Coma score changes
timeFrame: 3 days
measure: Sequential Organ Failure Assessment score changes
timeFrame: 3 days
measure: Acute Physiology and Chronic Health Evaluation II score changes
timeFrame: 3 days
measure: The average reduce rate of serum sodium
timeFrame: 3 days
measure: 24-hour correction of hypernatremia
timeFrame: 24-hour
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Nephrology
state: Shaanxi
Study officials:
affiliation: the First Affiliated Hospital of Fourth Military Medical University
name: Shiren Sun, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang C, Zhang P, Du R, Li Y, Yu Y, Zhou M, Jing R, Li L, Zheng Y, Wang H, Liu H, He L, Sun S. Treatment of acute hypernatremia in severely burned patients using continuous veno-venous hemofiltration with gradient sodium replacement fluid: a report of nine cases. Intensive Care Med. 2013 Aug;39(8):1495-6. doi: 10.1007/s00134-013-2933-9. Epub 2013 May 8. No abstract available.