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

This study has been withdrawn prior to enrollment.
(Inclusion criteria difficulties to receive the case, it is taken off the case to apply)
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01781585
First received: September 17, 2012
Last updated: April 11, 2014
Last verified: April 2014
  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)

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • hemodynamic stability during dialysis [ Time Frame: 2days ] [ Designated as safety issue: Yes ]
    Cardiac output and stroke volume variation measurements and ICP measurement


Secondary Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: August 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (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
Study Population

The inclusion criteria were end stage renal disease (ESRD) patients with increased ICP status post ICP monitor insertion

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01781585

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: VinCent Wu, MD National Taiwan University Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: April 11, 2014
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 September 15, 2014