Continuous Venovenous Hemofiltration Versus Conventional Treatment for Acute Severe Hypernatremia

NCT02449382 | Unknown

• 1 other identifier: CVVH-Na-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypernatremia; Critically Ill

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 7-day all cause mortality

  7days

Secondary Outcomes (5)

• Glasgow Coma score changes

  3 days

• Sequential Organ Failure Assessment score changes

  3 days

• Acute Physiology and Chronic Health Evaluation II score changes

  3 days

• The average reduce rate of serum sodium

  3 days

• 24-hour correction of hypernatremia

  24-hour

Study Arms (2)

continuous venovenous hemofiltration

ACTIVE COMPARATOR

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.

Procedure: continuous venovenous hemofiltration

Control group

ACTIVE COMPARATOR

Treatment of hypernatremia is correction of water deficit.

Drug: Control group

Interventions

continuous venovenous hemofiltration PROCEDURE

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

Also known as: continuous renal replacement therapy

continuous venovenous hemofiltration

Control group DRUG

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

Also known as: standard treatments

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 years
• Acute severe hypernatremia(increasing of serum sodium levels from normal levels to ≥160 mmol/L within 48 hours)
• ICU patients

You may not qualify if:

• Hypovolemic hypernatremia fractional excretion of sodium \<0.5% and Urea/Creatinine \>40 receiving diuretics: Urea/Creatinine \>40, No edema.
• Acute kidney injure network III
• End-stage renal disease Hemodialysis or peritoneal dialysis
• K+\>6.5mmol/L The drug is difficult to treat hyperkalemia
• Hydrogen ion concentration\<7.2 The drug is difficult to treat metabolic acidosis
• Acute pulmonary edema
• Systolic blood pressure \<90 mmHg vasoactive drugs in the treatment of systolic blood pressure less than 90 mmHg
• The heparin or low molecular allergic patients
• HIV positive patients
• Pregnant women or lactational pregnancy women
• Suspected tuberculosis patients

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Xijing Hospital of Nephrology

Xi'an, Shaanxi, 710032, China

RECRUITING

Related 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 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.

  PMID: 23653182 RESULT

MeSH Terms

Conditions

Hypernatremia; Critical Illness

Interventions

Continuous Renal Replacement Therapy; Control Groups

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Shiren Sun, M.D.

  the First Affiliated Hospital of Fourth Military Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiren Sun, M.D.

CONTACT

+8602984775193; sunshiren@medmail.com.cn

Feng Ma, M.D.

CONTACT

+8602984775193; 28186432@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 20, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 13, 2015

Record last verified: 2015-07

Locations

CN (1)