Back to resultsContinuous Venovenous Hemofiltration Versus Conventional Treatment for Acute Severe Hypernatremia
Primary Purpose
Hypernatremia, Critically Ill
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
continuous venovenous hemofiltration
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Hypernatremia focused on measuring continuous venovenous hemofiltration, conventional treatment, mortality, acute severe hypernatremia
Eligibility Criteria
Inclusion Criteria:
- Age≥18 years
- Acute severe hypernatremia(increasing of serum sodium levels from normal levels to ≥160 mmol/L within 48 hours)
- ICU patients
Exclusion Criteria:
- 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
Sites / Locations
- Xijing Hospital of NephrologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
continuous venovenous hemofiltration
Control group
Arm 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 of hypernatremia is correction of water deficit.
Outcomes
Primary Outcome Measures
7-day all cause mortality
Secondary Outcome Measures
Glasgow Coma score changes
On the third day of the Glasgow Coma score minus baseline of the Glasgow Coma score
Sequential Organ Failure Assessment score changes
On 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 changes
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
The average reduce rate of serum sodium
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)
24-hour correction of hypernatremia
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.
Full Information
NCT ID
NCT02449382
First Posted
May 11, 2015
Last Updated
July 9, 2015
Sponsor
Air Force Military Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT02449382
Brief Title
Continuous Venovenous Hemofiltration Versus Conventional Treatment for Acute Severe Hypernatremia
Official Title
To Effect and Safety of Continuous Venovenous Hemofiltration (CVVH) Versus Conventional Treatment for Acute Severe Hypernatremia in Critical Ill Patients: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Demographic (gender, age, race, weight, history of drug allergy, complicating diseases, drug combination and combination therapy)
CVVH treatment (time, blood vessel, blood flow, replacement fluid flow, the type and dose of anticoagulant, limited to the test group)
Vital signs (blood pressure, heart rate, respiratory frequency, body temperature)
Severity of disease
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypernatremia, Critically Ill
Keywords
continuous venovenous hemofiltration, conventional treatment, mortality, acute severe hypernatremia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
continuous venovenous hemofiltration
Arm Type
Active Comparator
Arm 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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Treatment of hypernatremia is correction of water deficit.
Intervention Type
Procedure
Intervention Name(s)
continuous venovenous hemofiltration
Other Intervention Name(s)
continuous renal replacement therapy
Intervention Description
If the serum sodium concentration >150mmol/L, When filter occurred clotting, replace the filter to CVVH treatment
Intervention Type
Drug
Intervention Name(s)
Control group
Other Intervention Name(s)
standard treatments
Intervention Description
If the serum sodium concentration ≤150mmol/L, When filter occurred clotting, as the end of treatment.
Primary Outcome Measure Information:
Title
7-day all cause mortality
Time Frame
7days
Secondary Outcome Measure Information:
Title
Glasgow Coma score changes
Description
On the third day of the Glasgow Coma score minus baseline of the Glasgow Coma score
Time Frame
3 days
Title
Sequential Organ Failure Assessment score changes
Description
On the third day of the Sequential Organ Failure Assessment score minus baseline of the Sequential Organ Failure Assessment score
Time Frame
3 days
Title
Acute Physiology and Chronic Health Evaluation II score changes
Description
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
Time Frame
3 days
Title
The average reduce rate of serum sodium
Description
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)
Time Frame
3 days
Title
24-hour correction of hypernatremia
Description
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.
Time Frame
24-hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age≥18 years
Acute severe hypernatremia(increasing of serum sodium levels from normal levels to ≥160 mmol/L within 48 hours)
ICU patients
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiren Sun, M.D.
Phone
+8602984775193
Email
sunshiren@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Ma, M.D.
Phone
+8602984775193
Email
28186432@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiren Sun, M.D.
Organizational Affiliation
the First Affiliated Hospital of Fourth Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital of Nephrology
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiren Sun, M.D.
Phone
+8602984775193
Email
sunshiren@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Feng Ma, M.D.
Phone
+8602984775193
Email
28186432@qq.com
First Name & Middle Initial & Last Name & Degree
Shiren Sun, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
23653182
Citation
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.
Results Reference
result
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Continuous Venovenous Hemofiltration Versus Conventional Treatment for Acute Severe Hypernatremia
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