Continuous Venovenous Hemofiltration Versus Conventional Treatment for Acute Severe Hypernatremia

Not Applicable

• Conditions: Hypernatremia; Critically Ill
• Interventions: Procedure: continuous venovenous hemofiltration; Drug: Control group

• Registration Number: NCT02449382
• Lead Sponsor: Air Force Military Medical University, China

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

Study Timeline

• Study First Submitted: 2015-05-11
• Study First Submitted QC: 2015-05-16
• Study First Posted: 2015-05-20
• Study Start: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-09
• Last Update Posted: 2015-07-13
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
continuous venovenous hemofiltration	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.
Control group	Control group	Treatment of hypernatremia is correction of water deficit.

Primary Outcome Measures

Name	Time	Method
7-day all cause mortality	7days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Xijing Hospital of Nephrology; 🇨🇳 Xi'an, Shaanxi, China