HypernatremiaNCT02449382
Continuous Venovenous Hemofiltration Versus Conventional Treatment for Acute Severe Hypernatremia
A study testing continuous venovenous hemofiltration in people with Hypernatremia and Critically Ill, run by Air Force Military Medical University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypernatremia, Critically Ill
- What is being tested?
- continuous venovenous hemofiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years
- Acute severe hypernatremia(increasing of serum sodium levels from normal levels to ≥160 mmol/L within 48 hours)
- ICU patients
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital of Nephrology
Xi'an, Shaanxi, 710032
Shiren Sun, M.D., +8602984775193, sunshiren@medmail.com.cn
Feng Ma, M.D., +8602984775193, 28186432@qq.com
About this study
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
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.
Read the 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
- Conditions
- Hypernatremia, Critically Ill
- Being tested
- continuous venovenous hemofiltration, Control group
- Keywords
- continuous venovenous hemofiltration, conventional treatment, mortality, acute severe hypernatremia
- Medical subject headings
- Hypernatremia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous venovenous hemofiltrationProcedure or surgery
Also called continuous renal replacement therapy
If the serum sodium concentration >150mmol/L, When filter occurred clotting, replace the filter to CVVH treatment
Control groupDrug
Also called standard treatments
If the serum sodium concentration ≤150mmol/L, When filter occurred clotting, as the end of treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: continuous venovenous hemofiltration |
| Control group | Active comparator | Treatment of hypernatremia is correction of water deficit. Receives: Drug: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day all cause mortality
Measured: 7days
Secondary outcomes (5)
Glasgow Coma score changes
On the third day of the Glasgow Coma score minus baseline of the Glasgow Coma score
Measured: 3 days
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
Measured: 3 days
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
Measured: 3 days
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)
Measured: 3 days
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.
Measured: 24-hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypernatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiren sun, Air Force Military Medical University, China
- Investigators
- Shiren Sun, M.D., Principal investigator, the First Affiliated Hospital of Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449382
- Sponsor's protocol ID
- CVVH-Na-002
- Status last verified
- Jul 2015
- First submitted
- 11 May 2015
- Last updated
- 13 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23653182
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02449382
- Acronym / sponsor ID
- CVVH-Na-002
- Conditions
- Hypernatremia, Critically Ill
- Keywords
- continuous venovenous hemofiltration, conventional treatment, mortality, acute severe hypernatremia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 20 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous venovenous hemofiltration | Active comparator | Procedure: continuous venovenous hemofiltrationCVVH 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. |
| Control group | Active comparator | Drug: Control groupTreatment of hypernatremia is correction of water deficit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age≥18 years
- Acute severe hypernatremia(increasing of serum sodium levels from normal levels to ≥160 mmol/L within 48 hours)
- ICU patients
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous venovenous hemofiltrationAlso: continuous renal replacement therapyIf the serum sodium concentration >150mmol/L, When filter occurred clotting, replace the filter to CVVH treatment | Procedure or surgery | continuous venovenous hemofiltration |
| Control groupAlso: standard treatmentsIf the serum sodium concentration ≤150mmol/L, When filter occurred clotting, as the end of treatment. | Drug | Control group |
Primary outcome
7-day all cause mortality
Time frame: 7days
5 secondary outcomes
Glasgow Coma score changes
Time frame: 3 days
Sequential Organ Failure Assessment score changes
Time frame: 3 days
Acute Physiology and Chronic Health Evaluation II score changes
Time frame: 3 days
The average reduce rate of serum sodium
Time frame: 3 days
24-hour correction of hypernatremia
Time frame: 24-hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
- Results publication: PubMed 23653182Huang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiren Sun, M.D. principal investigator
the First Affiliated Hospital of Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous venovenous hemofiltration in people with Hypernatremia and Critically Ill, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiren Sun, M.D. (+8602984775193, sunshiren@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day all cause mortality (time frame: 7days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02449382, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2015.