To Effect and Safety of Continuous Venovenous Hemofiltration (CVVH) Versus Conventional Treatment for Acute Severe Hypernatremia in Critical Ill Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 7-day all cause mortality
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years
- •Acute severe hypernatremia(increasing of serum sodium levels from normal levels to ≥160 mmol/L within 48 hours)
- •ICU patients
排除标准
- •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
研究组 & 干预措施
continuous venovenous hemofiltration
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.
干预措施: continuous venovenous hemofiltration (Procedure)
Control group
Treatment of hypernatremia is correction of water deficit.
干预措施: Control group (Drug)
结局指标
主要结局
7-day all cause mortality
时间窗: 7days
次要结局
- Sequential Organ Failure Assessment score changes(3 days)
- Glasgow Coma score changes(3 days)
- The average reduce rate of serum sodium(3 days)
- Acute Physiology and Chronic Health Evaluation II score changes(3 days)
- 24-hour correction of hypernatremia(24-hour)
研究者
Shiren sun
M.D.
Air Force Military Medical University, China