Continuous Venovenous Hemofiltration Versus Conventional Treatment for Acute Severe Hypernatremia

NCT ID: NCT02449382

Last Updated: 2015-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-06-30

Brief Summary

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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

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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

Conditions

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Hypernatremia Critically Ill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

continuous venovenous hemofiltration

Intervention Type PROCEDURE

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

Control group

Treatment of hypernatremia is correction of water deficit.

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type DRUG

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

Interventions

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continuous venovenous hemofiltration

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

Intervention Type PROCEDURE

Control group

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

Intervention Type DRUG

Other Intervention Names

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continuous renal replacement therapy standard treatments

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Shiren sun

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shiren Sun, M.D.

Role: PRINCIPAL_INVESTIGATOR

the First Affiliated Hospital of Fourth Military Medical University

Locations

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Xijing Hospital of Nephrology

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shiren Sun, M.D.

Role: CONTACT

+8602984775193

Feng Ma, M.D.

Role: CONTACT

+8602984775193

Facility Contacts

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Shiren Sun, M.D.

Role: primary

+8602984775193

Feng Ma, M.D.

Role: backup

+8602984775193

References

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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 nine cases. Intensive Care Med. 2013 Aug;39(8):1495-6. doi: 10.1007/s00134-013-2933-9. Epub 2013 May 8. No abstract available.

Reference Type RESULT
PMID: 23653182 (View on PubMed)

Other Identifiers

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CVVH-Na-002

Identifier Type: -

Identifier Source: org_study_id

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