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Continuous Venovenous Hemofiltration Versus Conventional Treatment for Acute Severe Hypernatremia

A

Air Force Military Medical University of People's Liberation Army

Status

Unknown

Conditions

Hypernatremia
Critically Ill

Treatments

Drug: Control group
Procedure: continuous venovenous hemofiltration

Study type

Interventional

Funder types

Other

Identifiers

NCT02449382
CVVH-Na-002

Details and patient eligibility

About

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.

Full 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

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

continuous venovenous hemofiltration
Active Comparator group
Description:
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.
Treatment:
Procedure: continuous venovenous hemofiltration
Control group
Active Comparator group
Description:
Treatment of hypernatremia is correction of water deficit.
Treatment:
Drug: Control group

Trial contacts and locations

1

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Central trial contact

Feng Ma, M.D.; Shiren Sun, M.D.

Data sourced from clinicaltrials.gov

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