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Continuous Venovenous Hemofiltration Versus Conventional Treatment for Acute Severe Hypernatremia

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02449382
Enrollment
60
Registered
2015-05-20
Start date
2015-06-30
Completion date
2017-06-30
Last updated
2015-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill, Hypernatremia

Keywords

continuous venovenous hemofiltration, conventional treatment, mortality, acute severe hypernatremia

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

Interventions

If the serum sodium concentration \>150mmol/L, When filter occurred clotting, replace the filter to CVVH treatment

DRUGControl group

If the serum sodium concentration ≤150mmol/L, When filter occurred clotting, as the end of treatment.

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
7-day all cause mortality7days

Secondary

MeasureTime frameDescription
Glasgow Coma score changes3 daysOn the third day of the Glasgow Coma score minus baseline of the Glasgow Coma score
Sequential Organ Failure Assessment score changes3 daysOn 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 changes3 daysOn 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 sodium3 daysThe 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 hypernatremia24-hourTwenty-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.

Countries

China

Contacts

Primary ContactShiren Sun, M.D.
sunshiren@medmail.com.cn+8602984775193
Backup ContactFeng Ma, M.D.
28186432@qq.com+8602984775193

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026