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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)

This study has been withdrawn prior to enrollment.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

September 17, 2012
April 11, 2014
August 2011
August 2011   (final data collection date for primary outcome measure)
hemodynamic stability during dialysis [ Time Frame: 2days ] [ Designated as safety issue: Yes ]
Cardiac output and stroke volume variation measurements and ICP measurement
Same as current
Complete list of historical versions of study NCT01781585 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
The Hemodynamic Effects During Sustained Low-efficiency Dialysis Versus Continuous Veno-venous Hemofiltration for Patients With Intracranial Hypertension in a Cross Over Study
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 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.

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.

Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

End- Stage Renal Disease Patients
Procedure: hemodialysis
Patients were randomized to receive CVVH or SLED and the next day on the other.
  • sustained low-efficiency dialysis
    Patients were randomized to receive CVVH or SLED and the next day on the other.
    Intervention: Procedure: hemodialysis
  • continuous veno-venous hemofiltration
    Patients were randomized to receive CVVH or SLED and the next day on the other.
    Intervention: Procedure: hemodialysis

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01781585
201107015RC
No
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: VinCent Wu, MD National Taiwan University Hospital
National Taiwan University Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP