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

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.

Study Overview

• Status: Unknown
• Conditions: Critically Ill; Hypernatremia
• Intervention / Treatment: Procedure: continuous venovenous hemofiltration; Drug: Control group

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shiren Sun, M.D.; Phone Number: +8602984775193; Email: sunshiren@medmail.com.cn
• Study Contact Backup: Name: Feng Ma, M.D.; Phone Number: +8602984775193; Email: 28186432@qq.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital of Nephrology
      • Contact: Shiren Sun, M.D.; Phone Number: +8602984775193; Email: sunshiren@medmail.com.cn
      • Contact: Feng Ma, M.D.; Phone Number: +8602984775193; Email: 28186432@qq.com
      • Principal Investigator: Shiren Sun, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: continuous venovenous hemofiltration; If the serum sodium concentration >150mmol/L, When filter occurred clotting, replace the filter to CVVH treatment; Other Names: continuous renal replacement therapy
Active Comparator: Control group; Treatment of hypernatremia is correction of water deficit.	Drug: Control group; If the serum sodium concentration ≤150mmol/L, When filter occurred clotting, as the end of treatment.; Other Names: standard treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
7-day all cause mortality	7days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glasgow Coma score changes	On the third day of the Glasgow Coma score minus baseline of the Glasgow Coma score	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	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	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)	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.	24-hour

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Principal Investigator: Shiren Sun, M.D., The First Affiliated Hospital of Fourth Military Medical University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: May 11, 2015
• First Submitted That Met QC Criteria: May 16, 2015
• First Posted (Estimate): May 20, 2015

Study Record Updates

• Last Update Posted (Estimate): July 13, 2015
• Last Update Submitted That Met QC Criteria: July 9, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: mortality; continuous venovenous hemofiltration; conventional treatment; acute severe hypernatremia
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease Attributes; Water-Electrolyte Imbalance; Critical Illness; Hypernatremia
• Other Study ID Numbers: CVVH-Na-002