The Hemodynamic Effects During Sustained Low-efficiency Dialysis Versus Continuous Veno-venous Hemofiltration for Patients With Intracranial Hypertension in a Cross Over Study (NSARF)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
End- Stage Renal Disease Patients |
Procedure: hemodialysis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Crossover Time Perspective: Prospective |
| Official Title: | The Hemodynamic Effects During Sustained Low-efficiency Dialysis Versus Continuous Veno-venous Hemofiltration for Patients With Intracranial Hypertension in a Cross Over Study (NSARF) |
- hemodynamic stability during dialysis [ Time Frame: 2days ] [ Designated as safety issue: Yes ]Cardiac output and stroke volume variation measurements and ICP measurement
- the difference between cardiovascular peptides, oxidative and inflammatory assays [ Time Frame: 2 days ] [ Designated as safety issue: No ]the difference between cardiovascular peptides, oxidative and inflammatory assays
| Estimated Enrollment: | 12 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
sustained low-efficiency dialysis
Patients were randomized to receive CVVH or SLED and the next day on the other.
|
Procedure: hemodialysis
Patients were randomized to receive CVVH or SLED and the next day on the other.
|
|
continuous veno-venous hemofiltration
Patients were randomized to receive CVVH or SLED and the next day on the other.
|
Procedure: hemodialysis
Patients were randomized to receive CVVH or SLED and the next day on the other.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The inclusion criteria were end stage renal disease (ESRD) patients with increased ICP status post ICP monitor insertion
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
Contacts and Locations| Contact: VinCent Wu, MD | +886937223218 | q91421028@ntu.edu.tw |
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan, 100 | |
| Contact: VinCent Wu, MD +886-937223218 q91421028@ntu.edu.tw | |
| Principal Investigator: VinCent Wu, MD | |
| Principal Investigator: | VinCent Wu, MD | National Taiwan University Hospital |
More Information
Publications:
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01781585 History of Changes |
| Other Study ID Numbers: | 201107015RC |
| Study First Received: | September 17, 2012 |
| Last Updated: | January 30, 2013 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
Sustained low-efficiency dialysis; Continuous venovenous hemofiltration; hemodynamic stability, Intracranial pressure |
Additional relevant MeSH terms:
|
Hypertension Kidney Diseases Kidney Failure, Chronic Intracranial Hypertension Vascular Diseases Cardiovascular Diseases |
Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013