Clinical Trial: Continuous Venovenous Hemofiltration Versus Conventional Treatment for Acute Severe Hypernatremia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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


Sponsor: Fourth Military Medical University

Current Primary Outcome: 7-day all cause mortality [ Time Frame: 7days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Glasgow Coma score changes [ Time Frame: 3 days ]
    On the third day of the Glasgow Coma score minus baseline of the Glasgow Coma score
  • Sequential Organ Failure Assessment score changes [ Time Frame: 3 days ]
    On the third day of the Sequential Organ Failure Assessment score minus baseline of the Sequential Organ Failure Assessment score
  • Acute Physiology and Chronic Health Evaluation II score changes [ Time Frame: 3 days ]
    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
  • The average reduce rate of serum sodium [ Time Frame: 3 days ]
    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)
  • 24-hour correction of hypernatremia [ Time Frame: 24-hour ]
    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.


Original Secondary Outcome: Same as current

Information By: Fourth Military Medical University

Dates:
Date Received: May 11, 2015
Date Started: June 2015
Date Completion: June 2017
Last Updated: July 9, 2015
Last Verified: July 2015