Continuous Venovenous Hemofiltration Versus Conventional Treatment for Acute Severe Hypernatremia

Critically Ill Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02449382
• Other study ID #: CVVH-Na-002
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2015
• Last updated: July 9, 2015
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: July 2015
• Source: Fourth Military Medical University
• Contact: Shiren Sun, M.D.
• Phone: +8602984775193
• Email: sunshiren[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Hypernatremia

Intervention

Procedure:
• continuous venovenous hemofiltration
If the serum sodium concentration >150mmol/L, When filter occurred clotting, replace the filter to CVVH treatment

Drug:
• Control group
If the serum sodium concentration =150mmol/L, When filter occurred clotting, as the end of treatment.

Locations

Country	Name	City	State
China	Xijing Hospital of Nephrology	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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 nin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day all cause mortality		7days	No
Secondary	Glasgow Coma score changes	On the third day of the Glasgow Coma score minus baseline of the Glasgow Coma score	3 days	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No