The Hemodynamic Effects During Sustained Low-efficiency Dialysis Versus Continuous Veno-venous Hemofiltration for Patients With Intracranial Hypertension in a Cross Over Study

Study Overview
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Brief Summary
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Hemodynamic instability occurs frequently during dialysis treatment and still remains as significant cause of patient mobility and mortality. Postoperative hemodynamic optimization has been proved to reduce morbidity in high-risk patients. Intracranial pressure increased can lead to further structural and functional impairment owing to its deleterious effect on the compromised microcirculation and metabolism. This study was to compare the intra-cerebral pressure (ICP) and hemodynamic parameters between the sustained low-efficiency dialysis (SLED) and continuous veno-venous hemofiltration (CVVH) in post- brain tramatic patients.

Detailed Description
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Patients and Methods This study was based on a clinical cohort study of the renal failure patients in the database of the National Taiwan University Surgical ICU Acute Renal Failure (NSARF) Study Group17-21, with the approval of the Institutional Review Board of the National Taiwan University Hospital (201107015RC). Study protocol The inclusion criteria were end stage renal disease (ESRD) patients with increased ICP status post ICP monitor insertion. We started the study after the hemodynamic stable and acceptable ICP less than 20mmHg22. The ESRD patients with active brain hemorrhage, cardiac arrhythmia during dialysis, residual urine output, with inotropic equivalent more than 15 were excluded. All the patients were ventilated in supine position in controlled-volume mode after stable from brain hemorrhage. During data collection, supportive therapies, ventilatory settings and vasopressor therapy were kept unchanged. Patients were randomized to receive CVVH or SLED and the next day on the other. The ICP monitor was equipped and the indwelling radial artery catheter connected to the FloTrac/Vigileo hemodynamic monitoring system and for whom the ultrafiltration rate was set around 1.0 kg/8hr to 1.5 kg/8hr according to fluid status. Ultrafiltration rate and sodium concentration were fixed during each session. Clinical assessment The biochemical parameters were measured using the Toshiba TBA-200FR Clinical Chemistry Analyzer (Toshiba, Tochigi-Ken, Japan). When multiple daily measurements were performed, the data obtained closest to 8:00 AM were analyzed 23. The baseline hemodynamic was defined as average of two hours prior dialysis in each dialysis sessions.

Official Title
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The Hemodynamic Effects During Sustained Low-efficiency Dialysis Versus Continuous Veno-venous Hemofiltration for Patients With Intracranial Hypertension in a Cross Over Study (NSARF)

Conditions
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End- Stage Renal Disease Patients

Intervention / Treatment
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* Procedure: hemodialysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: end-stage kidney disease with anuria status post ICP monitor insertion received Exclusion Criteria: acute dialysis patients end-stage kidney disease with uria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sustained low-efficiency dialysis<br>Patients were randomized to receive CVVH or SLED and the next day on the other. | Procedure: hemodialysis<br>* Patients were randomized to receive CVVH or SLED and the next day on the other.<br>|
| continuous veno-venous hemofiltration<br>Patients were randomized to receive CVVH or SLED and the next day on the other. | Procedure: hemodialysis<br>* Patients were randomized to receive CVVH or SLED and the next day on the other.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic stability during dialysis | Cardiac output and stroke volume variation measurements and ICP measurement | 2days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the difference between cardiovascular peptides, oxidative and inflammatory assays | the difference between cardiovascular peptides, oxidative and inflammatory assays | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sustained low-efficiency dialysis;, Continuous venovenous hemofiltration;, hemodynamic stability,, Intracranial pressure